Aug. 12, 2020 12:00 UTC

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Omega Therapeutics, a company pioneering a new category of genomic medicine through epigenomic programming, today announced the appointment of Dr. Roger Sawhney as Chief Financial Officer. Dr. Sawhney brings 25 years of financial and strategic expertise to Omega, with vast experience ranging from global investments in healthcare sectors to business and strategy development in the biopharma industry.

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Omega Therapeutics strengthens leadership team with appointment of Roger Sawhney, M.D. as Chief Financial Officer. (Photo: Business Wire)

Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics remarked, The addition of Roger as Chief Financial Officer strengthens our leadership team and positions Omega for continued success in 2020 and beyond, particularly as we look to further developing our epigenomic programming platform, exploring partnerships, and readying our lead indications for clinical development in 2021. Rogers stellar background, and breadth and depth of industry expertise, combined with his strategic and transactional experience are invaluable attributes, and I am proud to welcome him to the team.

Most recently, Dr. Sawhney served at KKR & Co. as Director of its healthcare investment platform in the Americas, where his work focused on investments across private and growth equity in the healthcare sector. While at KKR & Co., he was responsible for deal sourcing, diligence, investing, corporate governance and portfolio value realization, and he ultimately helped lead and manage investments in over five portfolio companies across KKRs healthcare platform.

Earlier, he held the role of Senior Vice President and Head of Corporate Strategy for Novartis AG, as well as Senior Vice President of Corporate Strategy and Business Development for Outcome Health, a privately-funded leader in the digital health space. In these roles, Roger was progressively responsible for growth initiatives, M&A, business development and global strategic planning.

Dr. Sawhney commented, "Omega has a compelling story, breakthrough science and an ambitious mission, so I am excited to join Mahesh and the team in their efforts to deliver transformative genomic medicine to patients, forging a new future of disease management. Through pursuing strategic financial and operational initiatives, I aim to assist Omega in successfully capitalizing on opportunities and achieving its clinical, regulatory, and financial milestones."

We are thrilled to announce that Roger has joined the Omega leadership team as CFO, said Noubar Afeyan, Ph.D., Chief Executive Officer of Flagship Pioneering and Co-founder and Chairman of the Board for Omega Therapeutics. His impressive background bolsters Omegas strategic position, which is especially relevant during these uncertain times in the global markets. I look forward to his contributions in helping Omega capitalize on opportunities in what is certain to be an impactful year for the company.

Dr. Sawhney has also served as Partner with both Bain and Company and the Boston Consulting Group, where he led and managed numerous investments across the life sciences, med-tech and digital health sectors, as well as transformation engagements for the worlds leading global biopharma companies. He has particular depth in M&A, BD&L, portfolio strategy and growth strategy. He earned his M.D. degree from Harvard Medical School and also holds a BA in Economics from Stanford University.

About Omega Therapeutics

Omega Therapeutics is a genomic medicine company advancing novel engineered therapeutics, Omegas Epigenomic Controllers, enabling controllable epigenomic programming into clinical development for a broad range of indications. These therapeutics deliver Precision Genomic Control by controlling Insulated Genomic Domains (IGDs), the fundamental structural and functional units of genomic regulation, by modulating single and multiple gene expression through epigenomic programming. IGDs encompass single or multiple genes and their associated regulatory elements, and are correlated with diverse diseases, including cancer, autoimmune, inflammatory, regenerative, metabolic, neurological conditions and rare diseases. Omegas Epigenomic Controllers deliver the required potent and durable therapeutic effect by precisely modulating or tuning single or multiple genes, up or down, with high specificity to unleash the human genomes innate capacity to cure disease without altering native genomic nucleic acid codes. Omegas Epigenomic Controllers also allow repeat dosing with controllable durability.

Founded by Flagship Pioneering in 2017, with a long-term vision to create a programmable, epigenetic-based genomic medicine platform that would identify novel targets, as well as medicines, Omegas epigenomic programming platform has identified and mapped IGDs and their structure and function in both healthy and diseased states across cell types. This scientific insight drives the discovery and development of Omegas novel Epigenomic Controllers, intended for clinical development across a range of therapeutic indications. To learn more please visit http://www.omegatherapeutics.com.

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Omega Therapeutics Strengthens Leadership Team with Appointment of Roger Sawhney, MD as Chief Financial Officer - BioSpace

Scientists have identified two new variants in the COL7A1 gene associated with recessive dystrophic epidermolysis bullosa (RDEB) in a three-year-old Chinese girl.

The findings expand the spectrum of known mutations causing the disease and also highlight the usefulness of two methods of genetic analyses clinical exome sequencing (CES) and minigene assay to identify these variants.

The case report, Novel biallelic variants in COL7A1 cause recessive dystrophic epidermolysis bullosa, was published in the journal Molecular Genetics & Genomic Medicine.

RDEB is a severe form of epidermolysis bullosa caused by mutations in the COL7A1 gene, which encodes a protein called type 7 collagen (COL7) that is essential for skin health.

In the report, investigators in China described the case of a young Chinese girl with RDEB who was found to carry two new mutations in COL7A1.

The three-year-old girl (of Han ethnicity) was the first child of a biologically-unrelated healthy couple. According to her parents, she lacked skin on her left leg at birth, and had been having multiple blisters and scarring on her limbs, trunk, and neck since.

Physical examination revealed her skin was in poor condition, especially on her knees, elbows, hands, and feet. She also showed signs of tooth decay, was missing several teeth, and had mild webbing on her toes (fused toes). Her parents also said she often had bloody or dark stools, a telltale sign the tissue lining her gastrointestinal tract was also affected.

She was initially suspected of having dystrophic epidermolysis bullosa, but a genetic test had never been performed to confirm the diagnosis.

In the study, the investigators used CES a technique in which the exome (all protein-coding genes) is scanned to look for disease-causing mutations to determine which mutations were causing her condition.

CES identified two genetic variants in COL7A1 (c.3867delT and c.5532+4_5532+5delAG), which were confirmed by Sanger sequencing, another gene sequencing method. Both mutations had never been described in the literature, and were not included in any public genomic databases.

The girl inherited each mutation from each of her parents. The one she inherited from her father (c.3867delT) was a disease-causing variant that led to the production of an abnormally short version of COL7. In turn, the one she inherited from her mother (c.5532+4_5532+5delAG) was thought to disrupt gene splicing, a process through which the same gene gives rise to different proteins.

To confirm the COL7A1 splicing impairment, the researchers used a minigene assay, a technique in which the portion of the gene sequence containing the mutation is inserted into a minigene construct that is then placed inside lab-cultured cells.

The assay confirmed that the maternally-inherited mutation disrupted splicing in COL7A1, resulting in DNA deletion deemed as disease-causing. The girls mother, who was pregnant with her second child, underwent amniocentesis and prenatal genetic testing to confirm if the fetus had inherited the same genetic mutations as the first child. No RDEB-related mutations or complications were found in the second child.

Our study expands the mutation spectrum of COL7A1 and demonstrated that CES and minigene assays were efficient tools for RDEB molecular diagnoses, the researchers concluded.

Joana holds a BSc in Biology, a MSc in Evolutionary and Developmental Biology and a PhD in Biomedical Sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells cells that made up the lining of blood vessels found in the umbilical cord of newborns.

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Jos holds a PhD in Neuroscience from Universidade of Porto, in Portugal. He has also studied Biochemistry at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario in London, Ontario, Canada. His work has ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimers disease.

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2 New COL7A1 Gene Mutations Discovered in Chinese Girl With RDEB - Epidermolysis Bullosa News

A model incorporating gene expression and clinical factors predicts response to anti-tumor necrosis factor (TNF) therapy in patients with rheumatoid arthritis (RA), according to study results published in Network and Systems Medicine.

Rheumatoid arthritis is a complex disease and the molecular factors that predict response to treatment are poorly understood. Using gene expression data from patients receiving anti-TNF therapy, investigators aimed to build a biomarker panel, which predicts response to anti-TNF therapies in patients with RA.

Using publicly available data, a comprehensive map of the human protein-protein interactome was generated and used to identify an RA disease module, which contained approximately 200 proteins. Within this module, 66% of the proteins had been previously linked to RA in genome-wide association studies, and the remaining were significantly enriched in similar Gene Ontology biological processes.

Microarray data were obtained from the Gene Expression Omnibus database for 58 women receiving anti-TNF therapy. Using a random forest machine-learning algorithm, the data were used to identify genes for which expression was predictive of response and nonresponse to therapy. Based on the microarray profile and the RA disease module, 37 genes were identified as discriminatory biomarkers for anti-TNF response.

In addition, RNA sequencing (RNAseq) data were obtained for 143 patients with RA from the Comparative Effectiveness Registry to Study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) study. In addition to gene expression, RNAseq data enabled the identification of single-nucleotide variations (SNVs; formerly single-nucleotide polymorphisms) that were associated with treatment response. An additional 22 SNVs, which were associated with the RA disease model, were identified that were linked to response to anti-TNF therapy.

With the inclusion of clinical factors, a total of 70 biomarkers were identified and used to train a machine-learning algorithm to predict response to anti-TNF therapy. The final model generated, which predicted nonresponse to anti-TNF therapy, consisted of 10 SNPs, 8 gene transcripts, 2 laboratory tests, and 3 clinical measures.

To confirm that the model was broadly generalizable, data from an independent group of 175 patients from the CERTAIN study were used for a validation trial. Patients who were identified by the model as being nonresponders to anti-TNF therapy were 6.57-times more likely to be a true nonresponder than a responder (95% CI, 2.75-15.70). The model predicted nonresponse to therapy with a positive predictive value of 89.7% (95% CI, 79.0-95.7%), a specificity of 86.8% (95% CI, 72.4-94.1%), and a sensitivity of 50.0% (95% CI, 40.8-58.7%). There was no significant difference observed in the predictive power of the model based on ethnicity.

When the relevant gene transcripts and SNVs were mapped to the human interactome, they were all within close proximity to the RA disease module as well as established RA drug targets, including Janus kinase and TNF-. Pathway enrichment identified genes involved in T-cell signaling as the most enriched pathway in the biomarkers associated with a therapeutic response.

Customization of treatment regimens to match the individualized disease biology of each patient is a goal of modern medicine, the researchers concluded. Development and validation of a drug response algorithm that predicts nonresponse to a targeted therapy using this machine-learning and network medicine approach show great promise for advancing precision medicine in the treatment of RA and other complex autoimmune diseases where costly therapeutic interventions are met with inadequate patient response.

Disclosure: This study was supported by Scipher Medicine Corporation. Please see the original reference for a full list of authors disclosures.

Mellors T, Withers JB, Ameli A, et al. Clinical validation of a blood-based predictive test for stratification of response to tumor necrosis factor inhibitor therapies in rheumatoid arthritis patients. Network and Systems Medicine. 2020;3(1):91-104.

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Clinically Validated Blood-Based Test Predicts Response to Anti-TNF Therapies in RA - Rheumatology Advisor

One day, cell and gene therapies will be as common as small molecules and antibody-based therapies are today, according to panelists at BIOs June 8 virtual session, The Next Generation of Medicine: Cell Therapies, Gene Therapies and Beyond.

Because cell and gene therapies have the potential to address complex biological issues such as dysregulation, translocation and mutations, they can use that power to change what the body is doing.

So, while small molecules and antibody therapies will still be around 30 years from now, they will be less important. Cell and gene therapies will dominate, James Sabry, global head of pharma partnering at Roche, said.

In focusing on the future of healthcare, Roche is investing in small company innovation. Its deals with Spark Therapeutics and Adaptive Biotechnologies are prime examples of what it seeks to achieve 10, 20 or even 30 years from now.

Were interested not just in the incremental improvements of antibody therapies or small molecules, but in identifying what could be the therapeutic modalities that will dominate the landscape, Sabry said.

That means cell and gene therapies. Already several gene therapies are approved and others are various companies pipelines.

Spark Therapeutics is working extensively in gene therapies for monogenetic disorders, including hemophilia, said Federico Mingozzi, CSO of Spark.

Spark is validating its gene therapy platform approach with the goal of using it against many more complex diseases.

Assuming a long time frame, one could even imagine using the body as a factory for making antibodies, Sabry said. Essentially, it could be possible to one day turn tissues into biofactories.

Adaptive Biotechnologies has taken its approach to immune-drive medicine from diagnostics into therapeutics.

The immune system doesnt make the distinction between therapeutics and diagnostics the way we do, said Harlan Robins, CSO and co-founder, Adaptive Biotechnologies.

His company focuses on T and B cell receptors, which bind to either pathogens or parts of pathogens, or, in the case of cancer, to mutated pieces of genes.

That binding is how the immune system discovers theres a problem, and its also is how it initiates an immune response, Robins said. Therefore, the same molecule is the diagnostic and targeting molecule. Whats distinct, he said, is the horsepower needed to move a therapeutic along in terms of development. Development for therapeutics is much more intense than for diagnostics. In this case, its partner Roche is providing the horsepower.

Next generation vectors are another hurdle to surmount in advancing cell and gene therapies to the next level, where they may tackle more complex diseases.

There are still enormous opportunities to use (our viral capsid) delivery vehicle for nucleic acids to make them more specific, Mingozzi said. There are a lot of ways to make AAVs more potent and drive expression of the therapeutic gene and then make it more controllable.

Improving the delivery platform will open it to new indications.

Eventually, adenoviral vectors (AVVs) likely will be replaced with more efficient (but not yet determined) delivery systems.

If you think about vectors as a delivery system and a genetic payload, you begin to think that are other ways to getting genetic material into a body, Sabry added.

Exosomes are one possibility, but the future may offer a library of different delivery mechanisms.

Sabry envisions a future in which genetic surgery is performed as routinely as anatomic surgery is performed today.

Imagine going in and removing a disease gene and replacing it with a normal gene, he said. Tight targeting could integrate it at the specific location of the disorder gene. Its not out of the realm of the possible.

The limitations of how to soup-up the genetic manipulations, have not yet been reached, panelists agreed. But there are a lot of barriers. Targeting, especially in cancer, remains a hurdle. To overcome that, Robins suggested making the cells themselves more powerful, but acknowledged safety concerns.

Another approach is to tailor cell therapies specifically to each patient, essentially redefining the meaning of personalized medicine by making therapies for individuals in real time. This necessitates considering not just the cells and the targeting mechanisms, but the integrated and interrelated networks the cells form.

Sabry suggested that Once we start to reestablish normal immune regulation, some of the concerns we have now about having cell therapy either too powerful or not powerful enough will go away. The reason, he said, is that you will be using the regular, nuanced regulatory systems that exist within the immune system to regulate its power and amplitude.

Achieving the future these panelists envision for cell and gene therapies requires companies to take risks. Currently, big pharma does that largely by partnering with or acquiring smaller, innovative companies. In acquisition, though, there is another risk: that the smaller company will be subsumed and lose its innovative drive and, thus, the very reason it was acquired. Therefore its important, Sabry insisted, that innovative companies operate independently, like Genentech and Spark, which both were acquired by Roche.

Its a matter of balance, Mingozzi said. You cant do everything yourself.

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BIO 2020: Cell and Gene Therapies Will Dominate Medicine in 30 Years - BioSpace

Entrenched in a legal battle with their manufacturer thats evidently blocking them from making their Covid-19 vaccine candidate, Inovio is making some leadership changes. Gene Kim will be president of Inovio Asia, while Mammen (Anza) Mammen jumps aboard the biotech as SVP, clinical development, and is slatedoversee development of Inovios DNA vaccine candidateINO-4800.

An ex-CFO at VGX Pharmaceuticals, Kim had previously been the CFO of AfreecaTV and video game developer WeMade Entertainment, both South Korean companies. And Mammen, who retired from the US Army with the rank of colonel, spent more than 6 years at Vical, becoming their SVP, clinical development, and prior to that role, was an infectious disease consultant and founding chief of the DoDs pandemic warning team at Fort Detrick, MD.

Starting July 13, Fargo, ND-based plasmid DNA manufacturer Aldevron will change CEOs. Kevin Ballinger, who was on the verge of being a lifer at Boston Scientific, will take the helm. Hes replacing Michael Chambers, who was named executive chairman of the board at Aldevron, which was founded on the campus of North Dakota State University in 1998 by Chambers and John Ballantyne. Ballinger was EVP and global president of Boston Scientifics largest division, interventional cardiology, for the past 9 years.

An R&D split is unfolding at Sangamo, where EVP of R&D Adrian Woolfson, who had only been with the California biotech since January 2019, has been shown the door. With a search underway for a new head of development, Biogen vet Jason Fontenot who has been Sangamos SVP of cell therapy steps up to the plate as interim head of research. Before joining Sangamo, Fontenot was CSO at Immusoft Corporation and, prior to that, founded Immune Automata Consulting. He spent 8 years at Biogen, where he was a group leader in immunology discovery.

Mental health and psychedelics biotech ATAI Life Sciences has launched IntroSpect Digital Therapeutics, naming David Keene president and CEO of the new platform. By using a variety of digital biomarkers, we stand to make treatments increasingly refined, effective, and most importantly for mental healthcare individualized, Keene said in a statement.Keene founded Everystory, which was later renamed Dthera Sciences in 2016, and was their chief technology officer, leading development of what has been described as an AI-enabled device for Alzheimers dubbed DTHR-ALZ.

Neuraptive Therapeutics focused on the treatment of peripheral nerve injuries has brought on Robert Radie to take over the helm of the company as CEO and chairman of the board. Radie has experience running operations as CEO at Zyla Life Sciences, Transmolecular and Topaz Pharmaceuticals (acquired by Sanofi Pasteur). In addition, hes held posts at Prestwick Pharmaceuticals, Morphotek and Vicuron Pharmaceuticals.

TheLaboratory for Advanced Medicine has wooed Samuel Tong as CEO of the companys Chinese operations. Tong hops aboard from NAMSA, where he served as VP and general manager of the Asia Pacific Region. Previously, he served in roles at QIAGEN, Abbott Vascular and GE Medical among others.

Effective July 30, Nicholas Green is succeeding Rick Hancock as president and CEO of California-based CDMO Avid Bioservices. Hancock had been interim president and CEO for the past year. Green jumps to Avid after 9 years as president and CEO of Therapure Biopharma, a company out of Mississauga, Ontario that also includes Therapure Manufacturing. He was also president and CEO of Rhodia Pharma Solutions and was briefly the president of the pharma division at Codexis.

Eli Lilly vet Allen Melemed has been named CMO of Chimerix, which six years ago found itself at the center of a hurricane of public anger over its initial refusal to provide their lead experimental drug to a dying child. Before his move to the Durham, NC-based biotech, Melemed was a Distinguished Medical Fellow and senior director of regulatory affairs oncology, North America at Lilly. Among the oncology medicines he worked on in his 20-plus years at the pharma giant is Verzenio, which just last week showed positive results in a Phase III trial for patients with high risk hormone receptor/HER2 negative breast cancer.

Another Eli Lilly vet, Thane Wettig, is headed to San Francisco biopharma FibroGen as their chief commercial officer. Prior to FibroGen, which just had its lead drug roxidustat for anemia accepted for review by the EMA, Wettig had been the chief commercial officer and metabolic franchise leader at Intarcia Therapeutics. Before then, Wettig was at Lilly for nearly 28 years, leaving as VP of global marketing, strategy and alliance management for Lilly Diabetes.

Respiratory infection-focused Meissa Vaccines has recruited Robert Jordan as their VP of R&D after a short tenure as Virs director of virology. Jordan also had a hand in the discovery and development of antiviral therapies, most notably remdesivir, when he was director of biology for Gilead. Before his time at Gilead, he was director of virology at Siga Technologies.

Josefin-Beate Holz has been named CMO at RNA epigenetics player Storm Therapeutics. Holz makes her way to the University of Cambridge spinout after being an independent clinical advisor since 2015. Her leadership experience includes tenures at Ablynx, GPC-Biotech, Gilead, Bristol Myers Squibb, OSI Pharmaceuticals (acquired by Astellas) and LEO Pharma.

Compass Pathways, the London mental health startup backed by Peter Thiel which grabbed $80 million in funding back in April, has welcomed Trevor Mill as chief development officer. Mill joins Compass after being SVP, head of global safety and regulatory sciences with Biogen. He was also Pfizers head of regulatory strategy, pharmatherapeutics, and spent 12 years overall at the pharma giant.

With its SER-109 program in Phase III development for recurrent C. diff, and trying to work its way back into the mix after 30% of its workforce was let go in early 2019, microbiome player Seres Therapeutics has named Terri Young EVP, chief commercial and strategy officer, effective June 29. Young is leaving Sage Therapeutics, where she was VP global commercial strategy. The GSK vet also spent time in leadership at Bristol Myers Squibb as VP and general Manager, cardiovascular.

Just a week after plugging in Will Kane as chief commercial officer, New Haven, CT pharma BioXcel Therapeutics has brought in Reina Benabou as SVP and chief development officer. Benabou, who joins BioXcel after being SVP & CMO at Cognivue, has a Big Pharma background that includes stints at Novartis (VP & worldwide medical head for the neuroscience franchise) and Pfizer (head of global medical product evaluation).

There are promotions galore at Coral Gables, FL-based Catalyst Pharmaceuticals, the maker of Firdapse to treat adults with Lambert-Eaton myasthenic syndrome. Jeffrey Del Carmen gets the bump to chief commercial officer after arriving at Catalyst in August 2018 as SVP of sales and marketing. Del Carmen had previously been VP of business development for Paragon Biosciences. Meanwhile, Pete Curry moves to VP of sales, and Maria Pandolfo has been promoted to VP of patient services.

After recently posting positive interim data for their Phase I trial, California-based biotech Adverum Biotechnologies has added a new face to the team with the appointment of Heikki Jouttijrvi as VP, manufacturing. Jouttijrvi hops aboard from Menlo Therapeutics, where he served as VP, technical operations. Previously, Jouttijrvi served in roles at Santen Pharmaceutical Company.

Sygnature Discovery, a Nottingham-based provider of drug discovery and preclinical services, has made a new addition to its leadership team with the appointment of Paul Overton as SVP of business development. Overton joins the company from Eurofins, where he served as head of European sales, marketing and key account management.

Cancer-focused Buffalo, NY biopharma Athenex has promoted Teresa Bair to general counsel and SVP, administration from her previous position of SVP, legal affairs and administration. Before making it to Athenex in 2015, Bair was a partner at Harris Beach.

Over at a different Catalyst, Charles Democko has moved to Catalyst Biosciences to become SVP, regulatory affairs. Democko had led CytomXs regulatory affairs and quality, and before that, he was VP of regulatory affairs at an array of companies such as Ascendis, KaloBios, Novacea, PharmacoFore, and Connetics.

Nascent Biotech out of San Diego has assigned Navpaul Singh to the role of chief medical consultant for Covid-19 research, particularly as it pertains to their lead product, Pritumumab. This opportunity with Nascent Biotech allows me to continue my medical work in viral infections that are with us today and possibly in the future, Singh said in a statement.

Canadian CRO Altasciences which previously inked a deal with fellow CRO WuXi last May has enlisted Joseph Francisco as chief toxicologist. Francisco joins with experience from his time at Charles River Laboratories, Seattle Genetics and Bristol Myers Squibb.

Partnering with Roches Genentech on an immuno-oncology collaboration, Bicycle Therapeutics has appointed Sir Keith Peters chairman of their scientific advisory board. Peters, the emeritus regius professor of physic at the University of Cambridge, was also on the board of medical advisers to Merck Research Laboratories and senior consultant in R&D for GSK.

Natural killer immunotherapy player Cytovia Therapeutics has added Leila Alland and Jane Wasman to their board of directors. Alland, the current CMO at PMV Pharma, was previously the CEO at Affimed and has held positions at such Big Pharmas as AstraZeneca, Bristol Myers Squibb and Novartis. Wasman, the chair of the board at Sellas Life Sciences, also spent 15 years at Acorda Therapeutics.

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Inovio adds two to the leadership team; Adrian Woolfson is out at Sangamo - Endpoints News

CHARLOTTESVILLE, Va., June 9, 2020 /PRNewswire/ --AMPEL BioSolutions announcesgenomic analysis and findingsthat could improve treatment of COVID19 patientswith approved drugs such as Embrel and Stelara. Published on bioRxiv as a preprint,the studyrevealsa gene-based test that will be able todeterminethose patients who may progress to severe illness with increased likelihood of morbidity. In addition, AMPEL's CovGENEapproach identifies FDA-approved drugs that may be appropriately repositioned to interfere with mechanisms that cause lung damage in severe COVID19 patients. The paper describes gene expression measured in three body compartments (lung, airway and blood) and integrates information from the blood and lung for a "whole body" understanding of the effects of SARS-CoV2 virus.

AMPEL's technology would complement the COVID19 diagnostics on the market that assess a patient as positive or negative for SARS-Cov2 infection. The application of AMPEL's approach could accelerate life-saving treatments for COVID19 patients by providing decision support to physicians for treatments that would reduce the uncontrolled activation of white blood cells that cause lung damage in the patients that experience the most severe illness.

About AMPEL BioSolutions LLC (2013-present)Precise Personalized Medicine through Genomics:Harnessing Big Data to Improve Healthcare

AMPEL BioSolutionsis a precision medicine company with a proprietary genomic platform, tools and machine learning algorithms.Profitability from in-house clinical trial design/management fueled R&D for gene-based disease diagnostics in the immunology space including lupus. Customersinclude leading pharmaceutical companies for analytics, genomic fingerprinting and identification of patients for clinical trials and diagnostics companies. Currently a privately held company by co-founders Drs. Amrie Grammer and Peter Lipsky, future funding will scale and commercialize diagnostics for autoimmune, inflammatory and infectious diseases anddecision supportfor physicians, healthcare systems and payors.

For further information please contact:

Kate Vega, AMPEL Director of Communications, (434) 326-8272,[emailprotected]

Amrie Grammer, AMPEL Co-Founder and COO/CSO, (240) 401-8889,[emailprotected]Twitter: @AmrieAMPELLinkedIn: Amrie Grammer PhD (amrie-grammer-phd-1351551b)www.ampelbiosolutions.com

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Virginia Based AMPEL BioSolutions' Technology Predicts Severity of Illness in COVID19 Patients and Identifies Treatments - PRNewswire

Cancer is caused by mutations that lead to uncontrolled cell division. One of the most aggressive types of cancer is glioblastoma, a form of brain tumour with a very poor prognosis. Relatively little is known about how mutations in non-coding regions drive glioblastoma. To address this knowledge gap, researchers at Uppsala University have performed whole-genome sequencing of DNA in tumour tissues from patients with glioblastoma and analysed the identified mutations.

One of our key tasks was to identify functional mutations associated with regulatory elements and potential relevance to the development of cancer cells, and to distinguish them from all random variations without presumed significance, says Professor Karin Forsberg-Nilsson at the Department of Immunology, Genetics and Pathology, Uppsala University.

The researchers assumed that DNA sequences that have remained unchanged in mammals throughout evolution are likely to have important functions. Therefore, they intersected the thousands of mutations they had found with information about evolutionary conservation of the genetic regions where the mutations lie.

The researchers validated their results using the gene SEMA3C, partly because they found a large number of mutations in non-coding regulatory regions near this gene and partly because previous findings, by others, suggest that SEMA3C is linked to a poor cancer prognosis.

We studied how mutations in non-coding regions affect SEMA3C's function and activity. Our results show that a specific, evolutionarily conserved, mutation in the vicinity of SEMA3C disrupts the binding of certain proteins whose task is to bind genes and regulate their activity, says Forsberg-Nilsson.

The study also identifies more than 200 other genes enriched for non-coding mutations in the regions concerned. These likely have regulatory potential, thus further increasing the number of genes that are relevant to the development of brain tumours.

Our results confirm the importance of the association between genetic alterations in non-coding regions, their biological function and disease pathology, concludes Forsberg-Nilsson.

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New method to identify genes that can drive development of brain tumours - ETHealthworld.com

Injecting mice with engineered, live bacteria has been shown to shrink cancer tumors. With trials underway to bring this immunotherapy solution to the clinic, Synlogic is paving the way for synthetic biology and living medicines to transform the landscape of healthcare and medicine.

In 1890, William Coley, a young cancer surgeon, was distraught. One of his first patients had just died of widespread cancer, despite Coley amputating his forearm. Determined to do something about it, Coley came across an intriguing solution.

The medical literature of the day hinted that dozens of cancer patients had a regression of their disease while they were also carrying a separate infection. Could the body, in fighting against a pathogen, also be battling a tumor? After injecting bacteria into a patient who showed tumor shrinkage, Coleys toxin, as it came to be known, was tried out on nearly a thousand patients to varying degrees of success.

Controversial at the time, and almost forgotten in the age of chemotherapy and radiotherapy, cancer immunotherapy (also known as immuno-oncology) has been rediscovered by modern-day researchers, who are leveraging the incredible power of our own human immune system to bring new cancer treatments to the mainstream.

William Coley is the grandfather of immunotherapy, says Aoife Brennan, CEO ofSynlogic, a synthetic biology company on the cusp of using live, engineered bacteria as a cancer drug in humans.A new study from the Synlogic teamshows that injecting cancerous mice with live, engineered bacteria can cause long-term remission of certain cancer types.

Many of the observations [Coley] had we are now rediscovering when we look at predictors of response to immunotherapy, Brennan told me. Weve really started to understand that stimulating an immune response can be an appropriate way to treat cancer.

Cancer immunotherapy has come a long way since Coleys day. Treatment options are now available that use antibodies to target specific proteins of cancer. These antibodies come as drugs, vaccines or immune cell infusions, and they work to enable the bodys natural defenses to fight cancer normally.

We also now know that tumors come in a wide range of forms. Some are hot and some are cold, but were not talking about temperature here.

A hot tumor shows signs of inflammation, meaning that the immune system is alert to the tumor and has dispatched T-cells to attack it. But they can get war-weary due to the presence of the bodys checkpoint system, which is there for a good reason: to stop immune cells from going too strong on the offensive. Tumors can trick this checkpoint system into ignoring cancer. Drugs known as checkpoint inhibitors can block these proteins, letting T-cells proceed with their attack.

The problem is that few tumors are hot. Cold tumors are more common and more deadly, including breast cancer, prostate cancer, and pancreatic cancer. How can we get the body to attack cold tumors, too? Heres where a living therapeutic system comes in.

We have this great platform to stimulate an immune response, Brennan says of the method Synlogic is pioneering to treat multiple forms of cancer. Our immune systems evolved to recognize pathogens and have a number of pathways to deal with them. We had this concept: what if we could engineer bacteria to stimulate the right immune responses and multiple different pathways in the same way an infection would?

To take advantage of both biotechnology and the human bodys amazing immune capabilities, companies like Synlogic work at the intersection of biology and engineeringa field we callsynthetic biologyto make useful biological applications. Using tools like gene editing and machine learning, synthetic biology researchers can, for example, develop a strain of bacteria that is stripped down to its bare essentialsyou can think of it as a chassis, like the basic framework of a car. They can then engineer that chassis to include specific, desirable components, and ultimately fine-tune its behavior and functions.

In Synlogics case, they are using these techniques to design living therapeutics programmed to treat disease in new ways. To develop a cancer therapy, Synlogics solution is to inject living bacteria directly into a tumor to stimulate the bodys defenses to act right where theyre needed, not unlike Willam Coley did all those years ago. The best part? Synthetic biology can be used to engineer bacteria that elicit an immune response but pose no danger of causing disease themselves, reducing a danger Coley first recognized in 1891.

Instead of using an attenuated [weakened] pathogen, Brennan continues, we are taking non-pathogenic bacteria and engineering in certain pathways and effectors that are important in the immune response. The first strain weve taken forward, to prove the pathway is viable, is called SYNB1891, in honor of William Coley and the year he injected live bacteria into a patients tumor.

To make their SYNB1891 strain, Synlogic started with a non-pathogenic version ofE. coliknown as the Nissle chassis. To it, they introduced a STING agonist from a different microorganism, Listeria. The STING agonist boosts the bodys defense pathways and is apotent inhibitor of pancreatic cancer. It is further engineered so that it only works in the specific anaerobic environment of the tumor its been injected into.

Once inside the tumor, these therapeutic bacteria can live for up to 10 days, acting like a flare that alerts the bodys immune cells to come and investigate whats going on. When they arrive, they engulf the bacteria with the STING agonist, which then triggers the persons immune system to target and attack the tumor itself.

The publication in Nature Communications highlights the effectiveness of Synlogics technique in mice and points to its potential for human therapeutics.

Weve looked in animals and shown that we can cause tumor regressions, even in cold tumors, says Brennan of the treatment. We can stimulate an immune response in mice that is tumor-specific and that causes complete remission.

In fact, the study shows that around one-third of mice with melanoma showed complete tumor rejection after tumors were injected with SYNB1891. The combined effect of the STING agonist and the bacterial chassis was crucial. Injection of the STING agonist alone led to 10% long-term survival of mice, but SYNB1891 injection increased that to 40%. With lymphoma, the effects were as high as 80% tumor rejection depending on the dose.

The treatment also appeared to provide mice with long-term protection in the form of immune memory. When cured mice were reexposed to the same tumor at least 60 days after the treatment, they remained tumor-free.

Promisingly, treatment of human cells with SYNB1891 led to a similar stimulation of the immune response as seen in mouse models, providing a positive indication that success in mouse models can be translated to treatments in people.

SYNB1891 is now in phase one clinical trials. The first patients that Synlogic is working with are those with cancers that can be accessed close to the skin surface, including breast cancer, melanoma, and lymphoma. The phase one study will slowly increase the dose of the live therapeutic, ensuring safety, primarily, as well as clinical effectiveness.

Weve worked with the FDA to carve a path for this kind of approach and are now treating patients who have tumors with the engineered bacteria, Brennan said.

An exciting prospect is the potential for treating a broad spectrum of tumors, regardless of the type, providing a more off-the-shelf solution that does not require the complexities of personalized treatments.

If you have the right immune cells in the vicinity and overcome some of the cloaking mechanisms that tumors use to evade the immune response, Brennan says, we can essentially take the brake off the immune system and allow it to do its thing with the cancer.

Where William Coleys pioneering experiments were met with skepticism in the late nineteenth century, Synlogic has picked up the mantle and is paving the way for the acceptance of live therapeutics as not just a viable option, but an effective one that can broaden and enhance the landscape of medicine.

The challenge, according to Brennan, is to show that this is a drug development approach that has legs.

With promising preclinical evidence and clinical trials underway for this synthetic biology approach, we hope its just a matter of time before this proof of concept becomes a life-saving treatment.

Follow me on twitter at @johncumbers and @synbiobeta. Subscribe to my weekly newsletters in synthetic biology. Thank you toPeter Bickertonfor additional research and reporting in this article. Im the founder ofSynBioBeta, and some of the companies that I write aboutincluding Synlogicare sponsors of theSynBioBeta conferenceandweekly digestheres the full list of SynBioBeta sponsors.

Originally published on Forbes: https://www.forbes.com/sites/johncumbers/2020/06/01/this-synthetic-biology-company-is-on-the-cusp-of-using-live-engineered-bacteria-as-a-cancer-drug/

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This Synthetic Biology Company Is On The Cusp Of Using Live, Engineered Bacteria As A Cancer Drug - SynBioBeta

When someone has a heart attack, it causes muscle cells in their heart to die, and the heart cannot regenerate these cells. Researchers at the University of Louisville have begun preclinical testing of a new gene therapy that stimulates regeneration of heart muscle cells.

The project, led by Tamer M.A. Mohamed, assistant professor of medicine in the UofL Division of Cardiovascular Medicine and the UofL Institute of Molecular Cardiology, has received a five-year, $3.8 million grant from the National Heart, Lung and Blood Institute.

After a patient suffers a heart attack, the heart loses muscle cells, reducing the hearts ability to pump blood to the rest of the body. Muscle cells in the heart do not regenerate on their own, leaving the heart permanently impaired, Mohamed said. We are developing a transient gene therapy approach to regenerate these muscle cells to heal the heart.

The therapy involves transient overexpression of a combination of four cell-cycle regulating proteins to induce cell division in the heart muscle. The four cell-cycle regulators, cyclin-dependent kinase 1 (CDK1), CDK4, cyclin B1, and cyclin D1, are known collectively as 4F, or four factors. In previous research, the process stimulated cell division in cardiomyocytes, or heart cells, leading to improved heart function.

The new study will determine further the effectiveness and safety of the therapy in animal models as well as in human heart segments using of a biomimetic culture system developed at UofL by Mohamed that keeps slices of human hearts alive for a longer period of time. The system mimics the environment of a living organ through continuous electrical stimulation and oxygenation, maintaining viability and functionality of the heart segments for six days, allowing more extensive testing. The heart culture system is available for use by researchers outside UofL.

In addition to further testing the therapys effectiveness, Mohamed and other investigators will focus on approaches for the process that do not lead to tumor development in other cells.

The challenge comes in avoiding development of cancer in other areas of the body, which appears to be a side effect of the process as seen in mice, Mohamed said.

If it is successful, the work will lead to the start of in-human clinical trials.

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ROCKLAND, Mass., May 29, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that updated data from the ongoing, single-arm Phase II VISION studyevaluating tepotinib* as a single agent in patients with advanced non-small cell lung cancer (NSCLC) with MET exon 14(METex14) skipping alterations were published in The New England Journal of Medicine(NEJM). Results from the primary analysis of data from 99 patients with at least 9 months of follow-up demonstrate consistent response rate and durable anti-tumor activity across lines of treatment in patients assessed by both liquid biopsy (LBx) and tissue biopsy (TBx).Results from the VISION study were also presented at the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program on May 29, including data from the primary analysis (Abstract #9556) and including patient-reported outcomes (PROs) of health-related quality of life (HRQoL) (Abstract #9575). Tepotinib is designed to be a highly selective1 oral MET inhibitor that is administered once daily and is designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations.

"METexon 14 skipping is a primary oncogenic driver, but until recently there have been no approved treatment options targeting this genetic alteration in NSCLC," said Paul K. Paik, M.D., primary study investigator, lead author and Clinical Director, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center. "These new findings highlight the importance of routine next-generation sequencing to identify METex14 skipping alterations and demonstrate tepotinib's durable anti-tumor activity in patients who are typically elderly, and whose cancers are often harder to treat."

This new analysis of data from 99 patients in the fully enrolled Cohort A with at least 9 months of follow-up was published by The New England Journal of Medicine on May 29. Results demonstrate objective response rate (ORR) of 46% (95% CI, 3657) among patients with METex14 skipping alterations identified by either LBx or TBx as assessed by Independent Review Committee (IRC), and 56% (95% CI, 4566) as assessed by investigators. The median duration of response (DOR) was 11.1 months (95% CI, 7.2could not be estimated (NE)) among patients with METex14 skipping alterations identified by either LBx or TBx as assessed by IRC, and 14.0 months (95% CI, 9.718.3) as assessed by investigators.Results were consistent across different lines of treatment and in patients assessed byLBx orTBx. Additional endpoints were progression-free survival (PFS) and overall survival (OS).

Patients with brain metastases at baseline (n=11) benefitted similarly from treatment. In these patients, systemic ORR as assessed by independent review was 55% (95% CI, 2383), with a median DOR of 9.5 months (95% CI, 6.6NE) and a median PFS of 10.9 months (95% CI, 8.0NE).

Results also include the first patient-reported quality-of-life outcomes in patients with NSCLC with METex14 skipping alterations. Quality of life was maintained over time of treatment with tepotinib, with symptoms of dyspnea remaining stable and cough symptoms improving. The first longitudinal on-treatment biomarker data fromLBx samples were also reported, showing high concordance between molecular circulating free DNA response (defined as METex14 depletion) and clinical response based on measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).

Out of 152 patients evaluable for safety, treatment-related adverse events (TRAEs) of all grades were reported in 135 patients (89%). Grade 3 TRAEs were reported in 38 patients (25%), and 3 patients (2%) experienced Grade 4 TRAEs. One death was considered by the investigator to be treatment-related and occurred in a 79-year-old patient with respiratory failure and dyspnea, secondary to interstitial lung disease. The most common Grade 3 TRAE was peripheral edema, which occurred in 11 patients (7%). Serious TRAEs were reported in 23 patients (15%). Permanent tepotinib discontinuations due to TRAEs were reported in 17 patients (11%), and 50 patients (33%) required a dose reduction due to TRAEs. Peripheral edema was the most common TRAE leading to a dose reduction (25 patients, 16%) or dose interruption (28 patients, 18%); permanent discontinuation was uncommon (7 patients, 5%).

"Designed to have a highly selective mechanism of action, tepotinib has the potential to make a difference in the treatment and lives of people living with non-small cell lung cancer harboringMETex14 skipping alterations," said Luciano Rossetti,Global Head of Research & Development for EMD Serono. "Following on the recent approval of tepotinib in Japan as the first therapy for the treatment of advanced NSCLC harboring MET gene alterations, the publication of these data underscores our commitment to advancing scientific understanding and potential therapeutic options for this challenging cancer."

The ongoing Phase II VISION (NCT02864992) clinical trial is a single-arm, open-label, multi-cohort study investigating the safety and efficacy of tepotinib as a single agent in patients with advanced or metastatic NSCLC with METex14 skipping alterations identified by LBx and/or TBx. The use of both LBx and TBx to identify patients for the VISION study is intended to support improved patient selection and is consistent with the company's focus on patient-centric drug development.

Lung cancer is the most common type of cancer worldwide, with2 million cases diagnosed annually.2Alterations of the MET signaling pathway are found in various cancer types, including 3% to 5% of NSCLC cases, and correlate with aggressive tumor behavior and poor clinical prognosis.3-5 Patients with NSCLC harboring METex14 skipping tend to be older than those with NSCLC harboring other alterations.6In the Phase II VISION study, the patient population is generally characterized as elderly, with a median age of 74.0 years, and as having poor clinical prognosis typical of NSCLC with METex14 skipping alterations.

In March 2020, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved tepotinib for the treatment of patients with unresectable, advanced or recurrent NSCLC with METex14skipping alterations.In September 2019, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy.EMD Serono plans to file tepotinib for regulatory review with the FDA in 2020. Tepotinib is also being investigated in the INSIGHT 2 study (NCT03940703) in combination with the tyrosine kinase inhibitor (TKI) osimertinib in epidermal growth factor receptor (EGFR)-mutated, MET amplified, locally advanced or metastatic NSCLC that has acquired resistance to prior EGFR TKI.

Discovered in-house at Merck KGaA, Darmstadt, Germany, tepotinib is an oral MET inhibitor that is designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations.

*Tepotinib is currently under clinical investigation and not yet approved in any markets outside of Japan.

Dr. Paik has provided compensated advisory services to EMD Serono.

About Non-Small Cell Lung Cancer With 2 million cases diagnosed annually, lung cancer (including trachea, bronchus and lung) is the most common type of cancer worldwide and the leading cause of cancer-related death, with 1.7 million mortality cases worldwide.2 Alterations of the MET signaling pathway, including MET exon 14 (METex14) skipping alterations and MET amplifications, occur in 3% to 5% of NSCLC cases.3-5

About TepotinibTepotinib is an oral MET inhibitor that is designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations. Discovered in-house at Merck KGaA, Darmstadt, Germany, it has been designed to have a highly selective mechanism of action,with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.Tepotinibis currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.Merck KGaA, Darmstadt, Germany, is actively assessing the potential of investigating tepotinib in combination with novel therapies and in other tumor indications.

References

All Merck KGaA, Darmstadt, Germany press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to http://www.emdgroup.com/subscribe to register for your online subscription of this service as our geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About EMD Serono, Inc.EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt,Germany in the U.S. andCanada- is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state ofMassachusetts.www.emdserono.com.

About Merck KGaA, Darmstadt, GermanyMerck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany generated sales of 16.2 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

SOURCE EMD Serono

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New England Journal of Medicine Publishes Primary Analysis of VISION Data for Tepotinib in Advanced NSCLC with METex14 Skipping Alterations -...

A study has found that disabling a gene in the myeloid cells of mice prevents them from developing obesity.

New research has found that inhibiting an immune cell gene in mice prevented them from developing obesity, even when they consumed a diet high in fat.

The studys findings, published in The Journal of Clinical Investigation, may one day help scientists develop therapies that can help people with obesity burn calories more easily.

Obesity is a major health issue, and in the United States, rates of the condition have risen over the past 40 years.

The Centers for Disease Control and Prevention (CDC) report that between 2017 and 2018, 42.4% of people in the country had obesity. Between 1999 and 2000, that figure was 30.5%.

Obesity increases the risk of heart disease, strokes, diabetes, and some types of cancer.

The CDC say that lifestyle changes, including eating a more healthful diet and getting more regular exercise, are key to reducing obesity.

One issue, however, involves obesitys effects on metabolism previous research in mice lead to the suggestion that a person with obesity burns fewer calories than a person who does not have obesity.

Better understanding how and why this might happen, and what scientists and clinicians can do about it, may help with reducing obesity.

In the present study, the researchers inhibited a gene in immune cells in mice. They did this because of an association between obesity and increased inflammation, and immune cells play a key role in controlling inflammation.

The researchers had wanted to find out what part the immune cells play in the metabolic complications of obesity. To their surprise, they found that the cells have a central role in regulating obesity and weight gain.

To study the effects of inhibiting the immune cell gene, the researchers conducted two experiments. In the first, they deleted the gene Asxl2, and in the second, they injected regular mice with nanoparticles that interfered with the function of the gene.

Once the researchers had inhibited this gene in the immune cells, they found that the mice did not develop obesity when fed a high fat diet, and that this was likely due to increased energy expenditure.

Compared with a control group of mice who had obesity but none of the gene inhibition, the mice with the inhibition burned 45% more calories, despite eating high fat diets.

For the studys principal investigator, Prof. Steven L. Teitelbaum, of the Washington University School of Medicine, in St. Louis, MO, Weve developed a proof of concept, here, that you can regulate weight gain by modulating the activity of these inflammatory cells.

It might work in a number of ways, but we believe it may be possible to control obesity and the complications of obesity by better regulating inflammation.

The team is not yet sure why inhibiting the gene in the mices immune cells resulted in them not gaining weight while on a high fat diet. The researchers suspect that the answer may involve encouraging white fat cells to burn fat rather than store it, as brown fat cells do.

While this is only preliminary research, the findings may eventually help people with obesity burn calories at a higher rate, supporting them as they make broader lifestyle changes that involve the diet and exercise.

According to Prof. Teitelbaum, A large percentage of Americans now have fatty livers, and one reason is that their fat depots cannot take up the fat they eat, so it has to go someplace else.

These mice consumed high fat diets, but they didnt get fatty livers. They dont get type 2 diabetes. It seems that limiting the inflammatory effects of their macrophages allows them to burn more fat, which keeps them leaner and healthier.

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Obesity in mice prevented by disabling gene - Medical News Today

By TONNY ABET

Dr Misaki Wayengera Dr Misaki Wayengera heads the Ministerial Scientific Advisory Committee on Covid-19 at Ministry of Health that is advising government on safeguarding the country from worst case pandemic scenario. He is in charge of coordinating the work of different experts on the committee.

Dr Misaki is also developing rapid diagnostic test kits for coronavirus, which are expected to be ready in a months time.

He has graduate training across Immunology, filoviruses, vaccinology, clinical microbiology and genetics. Dr Wayengera completed his PhD in 2018. He is member of the African Society for Human Genetics and inaugural chair of the H3Africa Consortiums Education and Coordinated Working Group (ECTWG, 2013-2016).

Dr Misakis research interests focus on Pathogen OMICS aimed at identifying new molecular targets for developing new diagnostics, therapeutics and vaccines.

Dr Misaki also developed testing kits for Ebola RDT, HIV-1 Gene Therapeutic, and next Gen TB Diagnostics. He is a bio-entrepreneur, and founder of Restrizymes Biotherapeutics (U) Ltd. In 2019, he won 1st Prize for the World Health Organisation (WHO) innovation Challenge (Product Development).

Prof Rhoda Wanyenze Prof Rhoda Wanyenze is an epidemiologist who is in charge of Covid-19 case modeling on the National Covid-19 Taskforce. She is a physician, public health consultant, academic and medical administrator, who serves as the Dean of Makerere University School of Public Health.

Born in 1968, Prof Wanyenze attended Nabisunsa Girls S.S. and earned her medical degree from Makerere University in 1993.

She studied Master in Public Health, also at Makerere in 2002, and a PhD from the University of Antwerp, Belgium, in 2010. She received additional training in HIV/Aids programme leadership and management, gender and health, project planning and management, and designing clinical research.

Dr Wanyenze has 25 years experience in health service delivery, including clinical, research, teaching, programme management, and policy development. Over the past seven years, she has served on boards of six organisations in Uganda.Prof Wanyenze sits on various boards, including that of Baylor-Uganda, and Uganda Aids Commission.

She is also a member of the Ministry of Health HIV Counselling and Testing Committee.

Prof Wilson Muhwezi Prof Wilson Muhwezi is an associate professor of Behavioural Sciences and Mental Health at Makerere University. He is heading the ad hoc committee on psychological interventions.

Prof Muhwezi is in charge of ensuring that putting people in quarantine, separation from family and re-integrating recovered patients is done with minimal effect on their psychological wellbeing.He also advises on how to fight the Covid-19 related anxiety and fears.

Born in 1967, he went to Bugamba Integrated Primary School in Mbarara District. He pursued his O-Level studies at Bugamba and A-Level at Nganwa High School.

In 1989, Muhwezi joined Makerere University to pursue a Bachelors Degree in Social Works and Social Administration. Prof Muhwezi did his Masters in Health Promotion from Bergen University in Norway between 1989 and 1998.He did his PhD in Medical Sciences/Social Medicine in both Karolinska Institute, Sweden, and Makerere University. He is a social scientist.

Prof Denis ByarugabaProf Denis Byarugaba is a microbiologist who heads the National Flu Surveillance Group. He is carrying out more research to understand the type of Covid-19 in the country. Dr Byarugaba has been studying different forms of coronavirus for more than 20 years. He unravels the new findings about the virus and localises Covid-19-related knowledge.

Dr Henry Kajumbula Dr Henry Kajumbura chairs the Infection and Biology committee. He is a microbiologist at Makerere University. He advises on safety measures such as wearing facemasks, hand-sanitising and social distancing.

He has been a clinical pathologist specialising in Medical Microbiology since 1998.

In recognition of his leadership role in the control of antimicrobial resistance in Uganda, Dr Kajumbula was nominated to chair the countrys Antimicrobial Resistance Surveillance Committee, a position he still holds.

As a result, he has coordinated development of the Countrys Nacrobial resistance as well as a national surveillance plan for antimicrobial resistance.

Prof Pontiano Kaleebu Prof Pontiano Kaleebu is a physician, clinical immunologist, HIV/Aids researcher, academic and medical administrator. He is the director of the Uganda Virus Research Institute (UVRI), which is in charge of testing for coronavirus. He advises government on testing for coronavirus and other disease-specific information.

Appointed in July 2010 as the new head of the UVRI, Prof Kaleebu holds a medical degree from Makerere University and a PhD from Imperial College, London.

Born in 1960, Kaleebu attended Jinja Kaloli Primary School in Wakiso District from where he completed and was admitted to St Marys College Kisubi for O-Level. He completed his A-Level from Kampala High School and joined Makerere University to pursue Bachelor of Medicine and Bachelor of Surgery in the mid-1980s.

In 1988, Kaleebu was awarded a scholarship by Royal Postgraduate Medical School, UK, to study immunology. Upon graduation, he pursued post-graduate studies at Imperial College -London where he completed his PhD programme in mid 1990s.

In 1987, Kaleebu was recruited as a medical research officer at UVRI while still pursuing his PhD studies. His service through the years saw him appointed as head of the Immunology Department at UVRI in 1995.While at UVRI, Prof Kaleebu joined the joint Medical Research Council, MRC/UVRI research programme in 1996. In July 2010, he was appointed as director of the UVRI.

As UVRI director, he sits on the senior management of the Ministry of Health. He leads a number of other national and regional networks of scientists and researchers.

Dr Jane Ruth AcengBorn in 1968, Dr Aceng is the Minister of Health, a position she has held since 2016. Her ministry has been at the centre of containing the coronavirus pandemic.

Dr Aceng studied from Shimoni Demonstration School in Kampala for primary and proceeded to Nabisunsa Girls School for both O- and A-Level education.

In 1993, she pursued a Bachelors Degree of Medicine and Bachelor of Surgery at Makerere University. Her career started off at Lira hospital in 1994 as a health officer. She grew through the ranks until she became a consultant paediatrician/ acting director in 2010. She later served as Director General of Health Services for five years until she was appointed Minister of Health. She has served through Ebola outbreaks and nodding disease syndrome.

Dr Joyce Moriku KaducuBorn in 1969 in Moyo District, Dr Joyce Moriku Kaducu, is a paediatrician, academic and politician. She was appointed Minister of State for Primary Healthcare in 2016, replacing Sarah Opendi. In 1984, she joined Laropi Primary School in Moyo District and proceeded to Metu S.S. in Moyo, for O- Level and Sacred Heart S.S. in Gulu District for A-Level education.

Dr Moriku joined Mbarara University Medical School in 2002, pursuing Bachelor of Medicine and Bachelor of Surgery. Dr Moriku has a PhD in Neuroscience from Gulu University in 2015.

She started working at Lacor Hospital in Gulu. She then worked as medical coordinator for The AIDS Support Organisation (Taso) in Gulu between 2003 and 2005. Dr Moriku later served as a medical director for Mildmay Clinic on Entebbe Road from 2008 to 2009.

Between 2010 and 2015, she was a lecturer in paediatrics at Gulu University and concurrently serves as a consultant pediatrician at Gulu Regional Referral Hospital.

Dr Diana Atwine Born in 1973, Dr Diana Atwine is the permanent secretary at the Ministry of Health, a position she has held since November 2016. She attended Bweranyangi Girls S.S. for O-Level and Mt St Marys Namagunga Girls School for her A-Level.

Dr Atwine pursued her Bachelor of Medicine and Bachelor of Surgery at Mbarara University School of Medicine, specialising in internal medicine. She started working at St Francis Hospital Nsambya, then joined the Uganda Joint Clinical Research Centre.

Dr Atwine moved to State House where she served as the Presidents Private Secretary in charge of medical affairs. In 2009, she was tasked to head the State Houses Medicine and Health Services Delivery Monitoring Unit.

Dr Henry Mwebesa is the Director General of Health Services at the Ministry of Health. He was appointed in February after serving as the Commissioner Health Services and Planning.

Col Dr Henry Kyobe Col Kyobe is the Covid-19 incident commander. He is an army doctor and senior consultant epidemiologist. He is deputised by Dr Atek Kagirita.

Dr Kyobe is responsible for emergency response, including quickly developing incident objectives, managing all incident operations, application of resources as well as responsibility for all persons involved.

Dr Jane NakibukaDr Jane Nakibuka is an intensivist and internal medicine expert at Mulago National Referral Hospital. She is heading the ad hoc committee on Covid-19 case management.

Dr Nakibuuka is behind the type of treatment being given to Covid-19 patients like the hydroxychloroquine, Vitamin C and antibiotics.

Other scientists Prof Noah Kiwanuka, is an Infectious Disease Epidemiologist at Makerere University College of Health Sciences. He is a member of the advisory committee. He harmonises strategies for case identification and infection prevention.

Dr Betty Kivumbi, is a mathematician, who is helping to develop Covid-19 models for Uganda. The models are used to predict how various measures being put or lifted could impact the extent of Covid-19 spread.

Prof Neoline Nakasujja, is a specialist in psychiatry and the Chair for the Department of Psychiatry where she serves as a senior lecturer at the Makerere University College of Health Sciences.

Prof Pauline Byakikais a Ugandan specialist physician and epidemiologist. She serves as an Associate Professor of Medicine at Makerere University College of Health Sciences.

Dr William Worodria, is a physician trained in pulmonology and clinical research. He is a member of the MSAAC. He has a Master of Medicine (Internal Medicine) from Makerere University, Kampala and a Doctorate from University of Antwerp, Belgium.

Dr Ethel Nakakawa, is a medical Microbiologist, College of Health Sciences, Makerere University. She holds a Masters in Medical and Diagnostic Virology.

Dr Arnold Kiwereza, is an anesthesiologist at Mulago National Referral Hospital who is also member of MSAAC.

Dr James Elima, is the director of Gulu Regional Referral Hospital.

Dr Byarugaba Baterana, is the executive director of Mulago National Referral Hospital.

Dr Moses Muwanga, is the director of Entebbe Grade B hospital.

Dr Susan Nabadda Ndidde, is the head of Central Public Health Laboratory that is also testing for coronavirus.

Prof Freddie Ssengooba Prof Freddie Ssengooba is a health policy expert heading the ad hoc committee on policy implication for Covid-19. He is in charge of assessing the public disposure and advises on the best way to put in place policies such as lockdown and when it should be lifted.

Prof Ssengooba is the director of the SPEED Project. SPEED refers to Support for Policy Engagements for Evidence-based Decisions for universal health coverage in Uganda.

Prof Ssengooba is also a lecturer in the Department of Health Policy, Planning and Management at the School of Public Health, College of Health Sciences, Makerere University.

He is a seasoned researcher in health systems and policy. In the last 12 years, Prof Ssengooba has led a programme of research on the organisational reforms like decentralisation of health services; autonomy and efficiency of hospitals; performance-based contracting and its impacts on health system in general and on the workforce in particular.

His current research engagements focus on the effectiveness of donor aid for HIV/Aids on the health system and researching the translation of evidence into policies and programmes.

He has provided technical services to World Health Organisation, World Bank, ministries of health, Uganda Aids Commission and multi-lateral and bilateral agencies.

Dr Monica Musenero Dr Monica Musenero is an epidemiologist and a veterinarian. She is the presidential adviser on epidemics.

She was among Ugandan experts who led the fight against Ebola outbreak in Sierra Leone in 2016 and DR Congo in 2018.Dr Musenero is a public health professional who has distinguished herself as a trailblazer in implementing strategic responses to medical emergencies.

Her service spans Ugandas Ministry of Health, local governments, higher education institutions, field epidemiology training programmes and engagements in various sub-Saharan countries.

She has engaged with multinational and multi-cultural leaders in both managerial and frontline contexts. Dr Museneros leadership versatility extends to initiatives that seek to build a critical mass of thought leaders to contribute to the countrys development agenda.

Dr Julius Lutwama Dr Julius Lutwama is a virologist leading the testing for coronavirus at UVRI. He has long-term experience in infectious disease diagnosis.

Dr Lutwama trained as an Entomologist, obtaining his PhD in 1991 and received further specialised training in molecular virology and entomology at the Centers for Diseases Control, Fort Collins, Colorado, US.

He is the acting deputy director of the Institute and he is the head of the Department of Arbovirology, Emerging and Re-Emerging Infectious Diseases at UVRI.

He also heads the WHO Collaborating National Influenza Centre and the Highly Infectious Diseases Diagnostic Laboratory at UVRI.

Dr Lutwama is Honorary Associate Professor in the Department of Medical Microbiology at the Makerere University College of Health Sciences.

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Gifted brains, hands in the Covid-19 fight - Daily Monitor

IRVINE, Calif. and AMSTERDAM, May 29, 2020 /PRNewswire/ -- Agendia, Inc., a world leader in precision oncology for breast cancer, announced that new data from ongoing clinical research on MammaPrint® and BluePrint® was debuted at the American Society of Clinical Oncology 2020 Virtual Scientific Program (ASCO) today. A total of five posters were presented on Agendia's genomic profiling assays.

The highlighted data below further illustrate the efficacy of Agendia's MammaPrint and BluePrint genomic testing to consistently stratify breast cancers, allowing for a highly personalized regimen throughout a patient's treatment journey. The latest findings from Agendia deliver immediate, actionable information for doctors and patients early in the diagnosis and treatment planning process and build on research that will impact breast cancer treatment and outcomes in the future.

One scientific presentation, entitled "Adding precision to 2018 ASCO/CAP HER2 testing guidelines in breast cancer with genomic profiling," evaluated the concordance between human epidermal growth factor receptor 2 (HER2) status as put forth by the 2018 ASCO/CAP guidelines and Agendia's BluePrint genomic testing. In this real-world diagnostic data set, the 2018 guideline recommendations led to fewer HER2 equivocal tumors overall, confirming the positive impact of the revisions. Of note, BluePrint reclassified 69 percent of HER2-positive tumors and all HER2 equivocal tumors to non-HER2 molecular subtypes, indicating that these tumors may have suboptimal responses to HER2-directed therapy. This study found that molecular classification by BluePrint adds further precision in stratifying HER2-positive patients, offering the potential to predict responsiveness to HER2-targeted therapies.

"In this study, nearly 70 percent of HER2-positive diagnoses were reclassified to non-HER2, based on molecular subtyping. This is interesting and may have the potential at some point to affect treatment decisions and patient outcomes," said Adam Brufsky, MD, PhD, and Professor of Medicine at the University of Pittsburgh School of Medicine. "Data continue to show the value of MammaPrint and BluePrint as diagnostic tools that allow physicians to make more informed decisions to address their patients' disease."

Also at ASCO, Agendia shared updates on the ongoing FLEX trial, the massive real-world clinical data set designed to drive the medical community forward in its approach to precision medicine. In addition to a designated FLEX study poster "The FLEX Real World Data Platform Explores New Gene Expression Profiles and Investigator-Initiated Protocols in Early Stage Breast Cancer" that gave general updates on the registry, Agendia also highlighted FLEX and forward-looking studies, one of which has immediate implications for how a patient's treatment may change based on comprehensive information uncovered by BluePrint.

The FLEX scientific presentation, entitled, "TNBC subtype and clinical estrogen receptor status of genomically basal breast tumors in Caucasian, African American, and Latin American patients," evaluated the distribution of triple-negative breast cancer (TNBC) subtypes in genomically Basal-Type cancers from self-reported patient ethnicities (Caucasian, African American, and Latin American). The data show that Basal-Type tumors are heterogeneous and include all defined TNBC subtypes, independent of ethnicity.

In addition, the study evaluated the association of IHC-determined estrogen receptor status and Basal-Type tumors of each ethnicity. Analyses demonstrated that BluePrint reclassified a subset of estrogen receptor positive (ER+) tumors to molecular Basal-Type and that ER status was not significantly associated with a specific TNBC subtype or ethnicity. This highlights the clinical need to trace basal biology in ER+ patients to refine treatment for basal-like tumors.

"The reclassification of a subset of ER+ tumors identifies an urgent and actionable situation," said Cathy Graham, MD, Assistant Professor of Surgery in the Division of Surgical Oncology at Emory University School of Medicine and Director, Breast Surgery at Emory St. Joseph's Hospital. "From a clinical perspective, when these patients are first diagnosed, they appear to have luminal breast cancer. But, when you are able to look at the underlying mechanism with comprehensive genomic testing, a large subset of these breast cancers is reclassified to Basal-Type, which is high risk. This knowledge allows us to execute a more personalized and precise treatment approach immediately."

Two other forward-looking studies reinforce the future utility of better stratifying patients, and Agendia's ability to provide a more sophisticated platform for discovery in gene signature research.

"The research we are showcasing at this year's ASCO Annual Meeting underscores our commitment to patients and physicians," said William Audeh, MD, Chief Medical Officer at Agendia. "With our growing arsenal of data collected through prospective clinical trials such as FLEX, I-SPY2 and MINDACT, we are able to help patients now while information-gathering for future breast cancer treatment strategy."

Agendia is proud to present these findings at the ASCO 2020 Annual Meeting, which underscore the company's commitment to innovation and discovery through extraordinary, patient-focused research.

About Agendia

Agendia is a precision oncology company committed to improving clinical outcomes and informing the journey for patients with early-stage breast cancer. The company currently offers two commercially available genomic profiling tests, processed through its state-of-the-art facility in Irvine, California. Agendia also provides a next-generation sequencing kit for use by local laboratories outside of the United States.

MammaPrint®, the 70-gene breast cancer recurrence assay, is the first FDA-cleared risk-of-recurrence test backed by peer-reviewed, prospective outcome data and included in both national and international treatment guidelines. BluePrint®, the 80-gene molecular subtyping assay, is a commercially available test that evaluates the underlying biology of a tumor to determine what is driving its growth. Together, MammaPrint and BluePrint provide a comprehensive genomic profile to help physicians make more informed decisions in the pre- and post-operative treatment settings. By developing evidence-based, novel genomic tests, Agendia aims to support the evolving clinical needs of breast cancer patients and their physicians.

Agendia's assays can be ordered on core biopsies or surgical specimens with results provided in as little as 5-7 days to inform pre- and post-operative treatment decisions. For more information on Agendia's assays and ongoing trials, please visit http://www.agendia.com.

About the FLEX Registry

Three years ago, Agendia launched a clinical trial for patients in the US, known as the FLEX Registry. It is a large-scale, prospective, observational breast cancer study that links whole transcriptome profiling, including MammaPrint and BluePrint, with complete clinical data. FLEX generates a comprehensive patient database with the potential to identify new gene associations with prognostic and/or predictive value in breast cancer.

View FLEX Registry details here.

About the I-SPY2 Study

The I-SPY2 trial looks at whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) beyond standard neoadjuvant chemotherapy for each biomarker signature established at trial entry. So far, findings support the use of residual cancer burden (RCB) as a prognostic indicator for three-year outcomes in patients pre-selected as high risk for recurrence, and the importance of MammaPrint in identifying these patients.

I-SPY2 breaks from the traditional randomized trial design, employing an 'adaptive' model that allows multiple treatments (up to six different agents) to be studied in parallel. This master framework also allows new agents to enter and leave the study without having to halt enrollment or resubmit the entire clinical trial protocol for regulatory review.

View the I-SPY2 trial site here.

About the MINDACT Trial

MammaPrint is supported by the highest level of clinical evidence (level 1A) from MINDACT, a landmark independent trial published in the New England Journal of Medicine in 2016.

MINDACT stands for Microarray In Node-Negative and 1-3 node-positive Disease may Avoid ChemoTherapy. It was a phase III, prospective, randomized, clinical study for a breast cancer recurrence test sponsored by the European Organization for Research and Treatment of Cancer (EORTC-10041/BIG3-04).

View the whole trial here.

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Agendia Announces Data Presented at ASCO 2020 Demonstrating Importance of Further Classification of Breast Cancers to Enable Precise Prognosis and...

BASKING RIDGE, N.J., Oct. 07, 2020 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq: CLBS) (Caladrius or the Company), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease, announced today that its Chief Medical Officer, Douglas W. Losordo, M.D., FACC, FAHA, will present at the Alliance for Regenerative Medicines (ARM) Cell and Gene Meeting on the Mesa, being held virtually on October 12-16, 2020.

The 2020 Cell and Gene Meeting on the Mesa will be delivered in a virtual format over the course of five days where attendees will be able to watch company presentations on-demand, in addition to two live-streaming panels each day. The Cell and Gene Meeting on the Mesa is the sectors foremost annual conference, bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies.

For more information on the conference, or to register, please visithttps://www.meetingonthemesa.com.

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease. We are developing first-in-class cell therapy products based on the notion that our body contains finely tuned mechanisms for self-repair. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.

The Companys current product candidates include CLBS119, a CD34+ cell therapy product candidate for the repair of lung damage found in patients with severe COVID-19 infection who have experienced respiratory failure, for which the Company plans to initiate a clinical trial in the coming weeks as well as three developmental treatments for ischemic diseases based on its CD34+ cell therapy platform: HONEDRA (formerly CLBS12), recipient of SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia (CLI) based on the results of an ongoing clinical trial; CLBS16, the subject of a recently completed positive Phase 2 clinical trial in the U.S. for the treatment of coronary microvascular dysfunction (CMD); and CLBS14, a Regenerative Medicine Advanced Therapy (RMAT) designated therapy for which the Company has finalized with the U.S. Food and Drug Administration (the FDA) a protocol for a Phase 3 confirmatory trial in subjects with no-option refractory disabling angina (NORDA). For more information on the company, please visit http://www.caladrius.com.

Contact:

Investors:Caladrius Biosciences, Inc.John MendittoVice President, Investor Relations and Corporate CommunicationsPhone:+1-908-842-0084Email:jmenditto@caladrius.com

Media:W2O GroupChristiana PascalePhone: +1-212-257-6722Email:cpascale@w2ogroup.com

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Caladrius Biosciences to Present at the Alliance for Regenerative Medicine's Virtual Cell and Gene Meeting on the Mesa - GlobeNewswire

Tom Hanks and his wife, Rita Wilson, were among the earliest celebrities to catch the novel coronavirus. In an interview at the beginning of July, Hanks described how differently COVID-19 had affected each of them in March.

My wife lost her sense of taste and smell, she had severe nausea, she had a much higher fever than I did. I just had crippling body aches, he said. I was very fatigued all the time and I couldnt concentrate on anything for more than about 12 minutes.

Why does COVID-19 present such different symptoms or none at all in different people?

Preexisting conditions can only be part of the story. Hanks is over 60 and is a Type 2 diabetic, putting him in a high-risk group. Nevertheless, he survived his brush with the virus with no pneumonia and apparently without any long-lasting effects. Knowing what causes variation in different patients could help physicians tailor their treatments to individual patients an approach known as precision medicine.

In recent years, a gene-centric approach to precision medicine has been promoted as the future of medicine. It underlies the massive effort funded by the U.S. National Institutes of Health to collect over a million DNA samples under the All of Us initiative that began in 2015.

But the imagined future did not include COVID-19. In the rush to find a COVID-19 vaccine and effective therapies, precision medicine has been insignificant. Why is this? And what are its potential contributions?

We are a physician geneticist and a philosopher of science who began a discussion about the promise and potential pitfalls of precision medicine before the arrival of COVID-19. If precision medicine is the future of medicine, then its application to pandemics generally, and COVID-19 in particular, may yet prove to be highly significant. But its role so far has been limited. Precision medicine must consider more than just genetics. It requires an integrative omic approach that must collect information from multiple sources beyond just genes and at scales ranging from molecules to society.

Inherited diseases such as sickle cell anemia and Tay-Sachs disease follow a predictable pattern. But such direct genetic causes are perhaps the exception rather than the rule when it comes to health outcomes. Some heritable conditions for instance, psoriasis or the many forms of cancer depend on complex combinations of genes, environmental and social factors whose individual contributions to the disease are difficult to isolate. At best, the presence of certain genes constitutes a risk factor in a population but does not fully determine the outcome for an individual person carrying those genes.

The situation becomes yet more complicated for infectious diseases.

Viruses and bacteria have their own genomes that interact in complex ways with the cells in the people they infect. The genome of SARS-CoV-2 underlying COVID-19 has been extensively sequenced. Its mutations are identified and traced worldwide, helping epidemiologists understand the spread of the virus. However, the interactions between SARS-CoV-2 RNA and human DNA, and the effect on people of the viruss mutations, remain unknown.

Tom Hanks and his wife caught the virus and recovered in a matter of weeks. Presumably each was infected over the course of a few minutes of exposure to another infected person, involving cellular mechanisms that operate on a timescale of milliseconds.

But the drama of their illness, and that of the many victims with far worse outcomes, is taking place in the context of a global pandemic that has already lasted months and may continue for years. People will need to adopt changes in their behavior for weeks or months at a time.

What should a precision medicine approach be in a pandemic? The gene-centric vision of precision medicine encourages people to expect individualized gene-targeted fixes. But, genes, behavior and social groups interact over multiple timescales.

To capture all the data needed for such an approach is beyond possibility in the current crisis. A nuanced approach to the COVID-19 pandemic will depend heavily on imprecise population level public health interventions: mask-wearing, social distancing and working from home. Nevertheless, there is an opportunity to begin gathering the kinds of data that would allow for a more comprehensive precision medicine approach one that is fully aware of the complex interactions between genomes and social behavior.

With unlimited resources, a precision medicine approach would begin by analyzing the genomes of a large group of people already known to be exposed to SARS-CoV-2 yet asymptomatic, along with a similar-sized group with identified risk factors who are dying from the disease or are severely ill.

An early study of this kind by Precisionlife Ltd data mined genetic samples of 976 known COVID-19 cases. Of these, 68 high-risk genes were identified as risk factors for poor COVID-19 outcomes, with 17 of them deemed likely to be good targets for drug developments. But, as with all such statistical approaches, the full spectrum of causes underlying their association with the disease is not something the analysis provides. Other studies of this kind are appearing with increasing frequency, but there is no certainty in such fast-moving areas of science. Disentangling all the relevant factors is a process that will take months to years.

To date, precision medicine has proven better suited to inherited diseases and to diseases such as cancer, involving mutations acquired during a persons lifetime, than to infectious diseases. There are examples where susceptibility to infection can be caused by malfunction of unique genes such as the family of inherited immune disorders known as agammaglobulinemia, but these are few and far between.

Many physicians assume that most diseases involve multiple genes and are thus not amenable to a precision approach. In the absence of the kind of information needed for a multi-omic approach, there is a clear challenge and opportunity for precision medicine here: If it is to be the future of medicine, in order to complement and expand our existing knowledge and approaches, it needs to shift from its gene-centric origins toward a broader view that includes variables like proteins and metabolites. It must consider the relationships between genes and their physical manifestations on scales that range from days to decades, and from molecules to the global society.

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How to use precision medicine to personalize COVID-19 treatment according to the patient's genes - The Conversation US

ALISO VIEJO, Calif.--(BUSINESS WIRE)--As gene-based diagnostics are shortening the path to an accurate diagnosis, the risk of disparities in service and support have increased. To reduce those disparities, Global Genes, a leading rare disease patient advocacy organization, is pleased to announce a new partnership with Rady Childrens Institute for Genomic Medicine (RCIGM) to develop a next-generation support network for families with gene-based diagnosed rare diseases.

Approximately 80 percent of rare diseases have identified genetic origins, many caused by defects in a single gene. Fifty percent of known rare diseases affect children and 30 percent of children with rare diseases die before the age of five years. Through Project Baby Bear, RCIGM diagnosed 35 rare conditions that occur in less than one in one million births. RCIGM demonstrated that access to rapid Whole Genome Sequencing (rWGS) not only shortens the time to diagnosis for newborn babies, but also reduces healthcare costs and downstream spending, primarily by empowering doctors to eliminate unnecessary procedures and discharge babies sooner.

RCIGM is recognized as a global leader in providing medical teams with life-changing genomic information to solve medical mysteries and improve outcomes for critically ill babies and children struggling to survive. They serve a growing network of more than 42 childrens hospitals nationwide. Its our joy and privilege to do work that offers hope and improves the lives of families and children with rare disease, said Stephen Kingsmore, M.D., DSc, president and CEO of RCIGM. When it comes to finding answers and support, we recognize that patient families face many challenges. Thats why we are delighted to team up with Global Genes to help connect the rare disease community with information on genomic medicine support services to break down barriers to diagnosis.

Through this novel partnership, Global Genes will work with RCIGM to connect patients and parents to needed services, support, education, and resources regarding genetic testing. Together, RCIGM and Global Genes aim to reduce the time to gene-based diagnoses and bring parents and patients the support they need, wherever they are in the country, said Christian Rubio, vice president, strategic advancement at Global Genes.

About Global Genes

Global Genes is a 501(c)(3) nonprofit organization on a mission to connect, empower, and inspire the rare disease community. We provide hope for more than 400 million people affected by rare disease around the globe. To date, weve educated millions of people in more than one hundred countries about rare disease, equipped patients and advocates with tools and resources, and provided hundreds of thousands of dollars in support for innovative patient impact programs. If you or someone you love has a rare disease or are searching for a diagnosis, contact Global Genes at 949-248-RARE or visit the resource hub.

About Rady Childrens for Genomic Medicine (RCIGM)

The Institute is leading the way in advancing disease-specific healthcare for infants and children through genomic and systems medicine research. Discoveries at the Institute are enabling rapid diagnosis and targeted treatment of critically ill newborns and pediatric patients at Rady Childrens Hospital-San Diego and a growing network of more than 40 childrens hospitals nationwide. The vision is to expand delivery of this life-saving technology to enable the practice of Rapid Precision Medicine at childrens hospitals across the nation and the world. RCIGM is a subsidiary of Rady Childrens Hospital and Health Center. Learn more at http://www.RadyGenomics.org. Follow us on Twitter and LinkedIn.

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GAITHERSBURG, Md., Sept. 1, 2020 /PRNewswire/ --Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company developing cell and gene therapies for cancer, autoimmune diseases and respiratory diseases, today announced that it has initiated a Phase 1/2 clinical trial of its lead RNA-engineered mesenchymal stem cell (MSC) therapy, Descartes-30, in patients with moderate-to-severe acute respiratory distress syndrome (ARDS), including that caused by COVID-19. Based upon the company's research and analysis, this program is understood to be the first RNA-engineered cell therapy to enter clinical development for ARDS and COVID-19. It is also the first cell therapy to specifically degrade NETs, webs of extracellular DNA and histones that entrap inflammatory cells, block alveoli and vessels, and drive the pathogenesis of ARDS and COVID-19.

"Patients with ARDS, especially those with COVID-19 ARDS, generate copious amounts of NETs that physically obstruct alveoli and vessels, which leads to respiratory distress, immune-mediated thrombosis and a vicious cycle of inflammation," said Bruce Levy, MD, Chief of Pulmonary and Critical Care Medicine at Brigham and Women's Hospital and Parker B. Francis Professor at Harvard Medical School, and a clinical investigator in the Descartes-30 trial. "We would therefore expect that degrading NETs would improve oxygenation as well as resolve thrombi and quell inflammation in these patients. If successful, Descartes-30 would be a highly differentiated game-changer within our limited toolkit in managing this exceedingly difficult condition."

Descartes-30 is an off-the-shelf (allogeneic) MSC product engineered with Cartesian's RNA ArmorySM cell therapy platform. By expressing a unique combination of DNases that work synergistically, Descartes-30 can eliminate large, macroscopic amounts of NETs within minutes. MSCs are inherently immunomodulatory and naturally travel to the lungs, where they are expected to provide continuous, local delivery of DNases to NET-laden lung tissue.

"We engineered Descartes-30 without genomic modification, and therefore the production of DNases is expected to be time-limited to match the acute nature of ARDS," said Metin Kurtoglu, MD, PhD, Chief Medical Officer at Cartesian. "Given thatDescartes-30will produce DNases locally and transiently, we anticipate that it will have a favorable benefit-to-risk profile. We also anticipate that these properties will enable Descartes-30 to treat a wide array of NET-related autoimmune and cardiovascular diseases."

About the Phase 1/2a Clinical Trial

The "Phase 1/2a Study of Descartes-30 in Acute Respiratory Distress Syndrome" (NCT04524962) is enrolling patients with ARDS at multiple critical care units in the United States. Patients with ARDS due to COVID-19 are given enrollment priority. This first-in-human study aims to determine the safety and preliminary efficacy of Descartes-30 in patients with moderate to severe ARDS. The study, which is estimated to begin treatment in September, aims to enroll approximately 20 patients prior to initiation of a larger study. For more information visit http://www.cartesiantherapeutics.com/Descartes-30-ARDS.

About ARDS and NETs

ARDS is a severe inflammatory lung disease with a mortality of over 40%. Inflammation leads to injury of lung tissue and leakage of blood and plasma into air spaces, resulting in low oxygen levels and often requiring mechanical ventilation. Inflammation in the lung may lead to inflammation elsewhere, causing shock and injury or dysfunction in the kidneys, heart, and muscles. Some causes of ARDS include COVID-19, severe pneumonia (including influenza), sepsis, trauma, and smoke inhalation.

NETs are inflammatory webs of DNA and proteins produced by neutrophils. NETs are commonly found in ARDS and are thought to exacerbate the disease by physically occluding air spaces and vessels, leading to reduced oxygenation and increased risk of immune thrombi. NETs are implicated in a variety of conditions beyond ARDS, including autoimmune and cardiovascular diseases.

About the RNA ArmorySM

The RNA ArmorySM is Cartesian's proprietary RNA-based cell engineering platform that activates and arms cells with carefully selected, mRNA-based therapeutics. Unmodified donor cells enter the RNA ArmorySMin the millions; a battle-ready cell army leaves the RNA ArmorySMin the tens of billions. Each cell is equipped with a combination of therapeutics rationally chosen to have a synergistic effect on the disease. In the body, the cells deliver a precision-targeted treatment regimen directly to the site of disease. The cells express therapeutics with a defined half-life, enhancing their safety profile and making repeat dosing and outpatient administration possible. The platform is agnostic to cell type: we choose the best cell for the job, whether autologous or off-the shelf. For more information visithttps://www.cartesiantherapeutics.com/rna-armory/.

About Cartesian Therapeutics

Founded in 2016,Cartesianis a fully integrated, clinical-stage biopharmaceutical company developing potent yet safer cell and gene therapies designed to benefit the broadest range of patients with cancer, autoimmune and respiratory diseases. Cartesianhas three products in clinical development under four open investigational new drug application (INDs) with the U.S. Food & Drug Administration (FDA). All investigational therapies are manufactured at Cartesian's wholly owned, state-of-the-art cGMP manufacturing facility in Gaithersburg, MD.Cartesian's commanding IP position benefits in part from a broad, exclusive patent license from the National Cancer Institute. For more information visithttps://www.cartesiantherapeutics.com/clinical-trials/.

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Cartesian Therapeutics Initiates Clinical Trial of First RNA-Engineered Cell Therapy for Acute Respiratory Distress Syndrome and COVID-19 - BioSpace

Read: The plan that could give us our lives back

The science is paying off. Novavax, a Maryland-based company working on this type of vaccine, recently reported the results of its Phase 1 trial. The levels of antibodies generated were stunning, about four times higher than those in individuals who are recovering from a COVID-19 infection.

Scientists are also using different strains of another virus, adenovirus, as a vector or a missile to deliver genes that code for these same spike proteins and that also provoke an immune response. The vector has been engineered in the lab to be replication-defective; that is, the vector is able to deliver the spike gene into humans but once its done its job, the vector cannot replicate any further. At least three groups are testing these vectors. A University of Oxford group, in partnership with AstraZeneca, has employed an adenovirus from chimpanzees and has already entered Phase 3 trials in humans. The Beth Israel Deaconess Medical Center group, in partnership with Janssen Pharmaceutica, is using Ad26, a human adenovirus, and the Chinese-based CanSino Biologics has begun Phase 3 trials with yet another human adenovirus, Ad5.

These examples are not just beautiful science (although they are beautiful science). By harnessing the increased power of the biological sciences, researchers are developing entirely new ways of rapidly developing vaccines.

My optimism doesnt stop with these early results, although they are key. Im also encouraged because at least five very different approaches (Ive walked through only three above) are being explored to make a vaccine. As we say in Canada, if you want to win, you have to take many shots on goal.

Equally important is the unprecedented global collaboration among scientists around the world, as well as the high degree of cooperation between scientists and clinicians, biopharmaceutical companies, government, philanthropic funders, and regulators. They are all working together toward the common goal of developing as quickly as possible a safe and effective vaccine against COVID-19.

I dont know which of the vaccine candidates undergoing clinical testing in humans will ultimately be shown to be safe and effective. They might all prove effective, albeit in different age groups or in people with different preexisting conditions. But the encouraging news is that all of the vaccine candidates that have entered trials in humans so far are safe and have elicited high levels of antibodies against COVID-19. Some have also been shown to activate the cellular arm of our immune system, another crucial component of our defenses against foreign pathogens.

The public-health imperative to obtain a safe and effective vaccine as quickly as possible goes hand in hand with the mandate that the approval process be above any political considerations and solely based on data from the clinical trials. Anything else risks losing the publics confidence in a vaccine or, in a worst-case scenario, might result in a vaccine that is less effective than those that might be approved later, or the widespread administration of a vaccine that turns out to have serious adverse side effects. That would be a public-health tragedy.

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Im Optimistic That We Will Have a COVID-19 Vaccine Soon - The Atlantic

Aug. 27, 2020 11:00 UTC

EMERYVILLE, Calif.--(BUSINESS WIRE)-- 4D Molecular Therapeutics (4DMT), a clinical-stage leader in the development of precision-guided AAV gene medicines based on directed evolution, announced the appointment of Susannah Gray to the Board of Directors. Ms. Gray brings more than 30 years of biopharmaceutical experience specifically in corporate finance and capital markets roles, most recently serving as EVP, Finance & Strategy of Royalty Pharma Management, LLC.

Susannahs extensive knowledge and experience in corporate finance and capital markets brings a valuable perspective to 4DMT. said David Kirn, MD, co-founder, chairman and chief executive officer of 4DMT. Susannahs appointment reflects our commitment to augmenting the capital markets expertise on the 4DMT board as we contemplate the capital required to support the clinical and preclinical development of our product candidates, two of which have recently entered the clinic. We look forward to benefiting from Susannahs extensive experience as we advance 4DMTs next-generation gene therapy programs.

Prior to joining 4DMT, Ms. Gray spent 14 years as executive vice president and chief financial officer of Royalty Pharma before retiring in 2019 just ahead of the Companys initial public offering. At Royalty Pharma, Ms. Gray led the Companys efforts to maximize its financial capabilities. She spearheaded the Companys successful implementation of a $2.3 billion credit facility in 2007 and has helped raise over $1.4 billion in equity capital for the Company. Prior to joining Royalty Pharma, Ms. Gray had a 14-year career in investment banking. In her most recent role, she was a managing director and the senior analyst covering the healthcare sector for CIBC World Market's high yield group from 2002 to 2004. She worked in a similar capacity at Merrill Lynch prior to joining CIBC World Markets. Ms. Gray joined Merrill Lynch in April 1999 after nine years at Chase Securities (a predecessor of JP Morgan), working in various capacities within the high yield and the structured finance groups. Ms. Gray received a BA with honors from Wesleyan University and holds an MBA degree from Columbia University.

I am excited to be part of this outstanding team at this key moment in the companys trajectory, said Susannah Gray. 4DMTs next-generation Therapeutic Vector Evolution platform enables the development of gene therapies with improved therapeutic profiles, enabling the company to pursue previously untreatable patient populations and to address a broad range of both rare and large market diseases. I look forward to working closely with the 4D team and supporting its mission to bring optimized gene therapies to patients.

About 4DMT

4DMT is a clinical-stage precision gene medicine company harnessing the power of directed evolution to unlock the full potential of gene therapy for rare and large market diseases in lysosomal storage diseases, ophthalmology, neuromuscular diseases, and cystic fibrosis. 4DMTs proprietary Therapeutic Vector Evolution platform enables a disease first approach to product discovery and development, thereby empowering customization of AAV vectors to target specific tissue types associated with the underlying disease. These proprietary and optimized AAV vectors are designed to provide targeted delivery by routine clinical routes of administration, efficient transduction, reduced immunogenicity, and resistance to pre-existing antibodies -- attributes that could enable the development of gene therapies that overcome known limitations of conventional AAV vectors. 4DMT vectors are designed to exhibit improved therapeutic profiles that enable the company to pursue previously untreatable patient populations and to address a broad range of rare and large market diseases.

4D Molecular Therapeutics, 4DMT, Therapeutic Vector Evolution, and the 4DMT logo are trademarks of 4DMT.

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4D Molecular Therapeutics Appoints Susannah Gray to Board of Directors - BioSpace

One of the most common misconceptions about CRISPR is that its only useful for gene editing. In reality, CRISPR can be used for a wide variety of non-gene editing applications, ranging from diagnostics to antiviral applications.

There is also a perception that the gene-editing mechanism of CRISPR is the bottleneck for curing all disease. The reality is that, for many applications, the bottleneck is actually our understanding of the genetic code itself or the limitations of what changing that code can actually accomplish. How factors interplay with our genetic code to produce diseases is a field that is critical for unlocking gene editings full potential.

One of the most perplexing aspects of COVID-19 is its enormous range of symptoms. Three people might contract it and have no overlap in their experience. Precision medicine an innovative approach to care that takes into account an individuals genes, environment, and lifestyle is playing a key role in understanding the genetic and environmental factors that might explain why one person is asymptomatic while another must be put on a ventilator, says Cameron Fox, Specialist on Precision Medicine at the World Economic Forum, and an expert in COVID-19 diagnostics technology.

Beyond the current crisis, this innovative work will have lasting, positive effects on many facets of the health ecosystem. One example is CRISPR-based diagnostics. CRISPRs ability to rapidly and accurately diagnose a wide range of diseases is only now being seriously explored. If this technology can be perfected, it would be a gamechanger in our fight against COVID-19, Fox continues.

Mammoth Biosciences is a World Economic Forum Global Innovator at the forefront of these developments. Here are five things Mammoths Co-Founder and CEO Trevor Martin thinks are important to know about how the field is evolving in the era of COVID-19.

The advent of CRISPR-based diagnostics fundamentally means a better understanding of the molecular world around us for areas ranging from human disease to crop health.

Infectious disease is a key use-case area for the diagnostic applications of CRISPR. Its become clear that one of its most powerful uses is its ability to provide reliable molecular information quickly and in a variety of formats.

International borders, workplaces, homes and maybe even concerts, conferences or other large events could benefit greatly from having tests for COVID-19 (and other diseases) that give gold-standard results within minutes. During a pandemic, this type of information is critical for fully reopening economies and engaging in robust contact tracing.

We created a robust test for the novel coronavirus within weeks particularly important as we contemplate the fact that it is a matter of when, not if, we must combat future pandemics beyond the current one, says Trevor Martin.

Beyond these more immediate uses, there is exciting potential for testing our environment more broadly, through monitoring samples from sewage or air. These measurements could give us unprecedented insight into our ecosystems and how they influence our health.

As CRISPR-based diagnostics pave the way for decentralized testing, the technological disruption will also open the door for accelerated adoption of value-based care models, rather than fee-for-service healthcare as in the United States.

Decentralized testing allows people to have more control over their own health and understand better when and how to interact with the healthcare system. Ideally, robust and prevalent diagnostics could mean fewer physical visits to a doctor (and shorter wait times), but the same or higher quality of care for more people by supercharging a doctors ability to care for patients through virtual consultations.

To reach its full potential, decentralized testing needs to go beyond its current model of expensive and complicated boxes with cartridges and embrace fully democratizable formats that can be used by individuals without extensive training. For example, Mammoth is creating CRISPR-based tests for diseases like COVID-19 in a format similar to a pregnancy test. This truly decentralized testing will allow for greater access to care and better information about when to seek it.

The application of precision medicine to save and improve lives relies on good-quality, easily-accessible data on everything from our DNA to lifestyle and environmental factors. The opposite to a one-size-fits-all healthcare system, it has vast, untapped potential to transform the treatment and prediction of rare diseasesand disease in general.

But there is no global governance framework for such data and no common data portal. This is a problem that contributes to the premature deaths of hundreds of millions of rare-disease patients worldwide.

The World Economic Forums Breaking Barriers to Health Data Governance initiative is focused on creating, testing and growing a framework to support effective and responsible access across borders to sensitive health data for the treatment and diagnosis of rare diseases.

The data will be shared via a federated data system: a decentralized approach that allows different institutions to access each others data without that data ever leaving the organization it originated from. This is done via an application programming interface and strikes a balance between simply pooling data (posing security concerns) and limiting access completely.

The project is a collaboration between entities in the UK (Genomics England), Australia (Australian Genomics Health Alliance), Canada (Genomics4RD), and the US (Intermountain Healthcare).

COVID-19 has opened many peoples eyes to the massive and surprising gaps in infectious disease diagnostics.

Diagnostics is, currently, a space where you must choose between a highly accurate result that requires long turn-around times and trained personnel and/or expensive equipment or a rapid result in an accessible format that sacrifices sensitivity and specificity.

COVID-19 has also made us more conscious of our shared responsibility to combat these unique types of diseases that we silently spread to each other. Hopefully, through focused investment in technology development as well as an elevated societal and government focus on detecting, curing and preventing infectious diseases, we can not only fight this pandemic but come out stronger against emerging infectious diseases.

The adage an ounce of prevention is worth a pound of cure will be more relevant than ever as weve seen the devastating effects and herculean efforts required to control and cure an infectious disease once it has evaded containment and prevention techniques.

As part of the focus on prevention, we need to ensure that as many people as possible have access to and entry points into broader healthcare networks. Access in particular should become a key focus as this pandemic has highlighted that we are only as strong as the most vulnerable among us. This challenges the current model of service-based healthcare.

Furthermore, biotechnology will become a top strategic priority for many governments, as an ability to prevent and mitigate a pandemic is an enormous political and economic advantage. It will become ever more important to understand and focus on how to communicate sound science broadly and in a way that all people trust. Weve seen in this pandemic that the increased use of pre-print servers has accelerated an amazing new model for rapidly disseminating cutting-edge science so people around the world can collaborate and build on it quickly. At the same time, it is harder than ever for individuals to know what is relevant and real. It will be important to find ways to retain the shift in pace, speed and openness of communication while maintaining the reliability and trust that gatekeeping mechanisms like peer-reviewed journals have long tried to provide.

Reliable, accurate and understandable information is key for both. We need consensus sources of information that are trusted by diverse groups and backed by strong science internationally.

People want what is best for their communities, their families and themselves, but it can be hard to separate fact from fiction. It is all the more important to ensure we have robust and frequent communication about science as well as forums that allow for stakeholders of all stripes to participate in a conversation on their benefits and drawbacks.

Ethical use of these technologies should not and cannot be determined only by a single group or individual. It is a shared responsibility across patients, industry, government and civic leaders. Understanding the molecular world and modifying it are increasingly tractable and accessible notions, but the use and misuse of technologies like CRISPR are important topics that have no easy answers.

The bottom line: It is critical that the public has an opportunity to understand how these technologies work and access to informed and rigorous sources of information for doing so, concludes Trevor Martin. Equally important, we must make sure that this information and insight is distributed widely and equally so that all of us participate in shaping and can benefit from these exciting advances.

Image: World Economic Forum

Last year, the World Economic Forum launched Strategic Intelligence, its flagship digital product to help individuals and organizations see the big picture on the global issues facing the world. It provides a tremendous resource for exploring the interconnections between over 250 different topics and keeping up to date on everything that could potentially be an opportunity or a risk to you or your organization. Strategic Intelligence enables organizations, like the Global Innovators, to keep abreast of risks, opportunities and trends, enabling them to take more of a data-driven approach to managing their business.

Read more:
5 things to know about CRISPR and gene editing in the COVID era - World Economic Forum