Las Vegas, USA, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Advanced Pancreatic Cancer Pipeline Therapeutics and Analysis, 2021

ERYtech Pharma, GlaxoSmithKline, Galera Therapeutics, Propanc and several other key companies are set to transform the Advanced Pancreatic Cancer Pipeline landscape in the coming years.

DelveInsights, Advanced Pancreatic Cancer Pipeline Insights, 2021 report provides comprehensive insights about 100+ companies and 100+ pipeline drugs in the Advanced Pancreatic Cancer pipeline landscape. It comprises Advanced Pancreatic Cancer pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Advanced Pancreatic Cancer therapeutics assessment by product type, stage, route of administration, and molecule type, and further highlights the inactive Advanced Pancreatic Cancer pipeline products.

Key Advanced Pancreatic Cancer Pipeline Report Highlights

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Advanced Pancreatic Cancer means cancer has spread from where it started or has come back sometime after treatment (recurrence). Advanced Pancreatic Cancer Treatment is usually chemotherapy. Chemotherapy travels via the bloodstream to reach cancer cells, which are in many places throughout the body. This treatment may reduce the tumors or impede their growth and may benefit patients to live longer.

Advanced Pancreatic Cancer Pipeline Therapeutics

The lead product candidate, Eryaspase consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cells altered asparagine and glutamine metabolism. Eryaspase is in phase III clinical development for the second-line pancreatic cancer treatment and in phase II for first-line triple-negative breast cancer treatment. Leveraging its proprietary ERYCAPS platform that utilises a novel technology to encapsulate drug substances inside red blood cells, ERYtech develops a pipeline of product candidates for patients with high unmet medical needs.

For further product profiles, request @ Advanced Pancreatic Cancer Pipeline Insight Report

Scope of Advanced Pancreatic Cancer Pipeline Drug Insight

Key Questions regarding Current Advanced Pancreatic Cancer Treatment Landscape and Emerging Therapies Answered in the Pipeline Report

Table of Contents

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Advanced Pancreatic Cancer Pipeline Therapeutics and Analysis, 2021 - GlobeNewswire

IRVINE, Calif., Jan. 26, 2021 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced that Ernesto Salegio, PhD will join the Company as Vice President, Segment Leader Translational and Pre-Clinical Research as part of ClearPoints Biologics and Drug Delivery team on March 1, 2021. Dr. Salegio brings over 19 years of experience in translational neuroscience with direct pre-clinical central nervous system (CNS) expertise in the delivery of therapeutics to the brain and spinal cord, including over 16 years of gene therapy experience working with adeno-associated viral vectors (AAV).

ClearPoint Neuros Biologics and Drug Delivery team was established in 2020 to provide turn-key medical device innovation, therapy delivery development and clinical services customized for both pharmaceutical and academic partners working on gene and stem cell therapies to the brain. This team also offers comprehensive services to help its partners navigate existing regulatory guidance and stay abreast of anticipated changes to guidance that will inevitably come.

Our current and prospective partners working on gene and stem cell therapies have an enormous unmet need for pre-clinical support, commented Jeremy Stigall, Vice President, Biologics & Drug Delivery Development. Ernestos extensive pre-clinical expertise in the intraparenchymal administration of therapeutics under image-guidance, as well into cerebrospinal fluid (CSF), will allow ClearPoint to add crucial translational consulting services for our biologics partners. When we establish relationships with pharmaceutical partners well before the clinic, ClearPoint products and services can be incorporated throughout the entire development process, delivering consistent, predictable performance, and providing government agencies assurance that the navigation and delivery platform will remain constant from bench-to-bedside. We aim to become their comprehensive medical device partner, allowing them to focus on more traditional pharmaceutical challenges, while ClearPoint delivers state-of-the-art medical device and therapy delivery.

I am thrilled to become a member of the ClearPoint team, commented Dr. Salegio. After spending almost two decades focusing on translational research, image-guided delivery protocols, complex surgical procedures and in the development of CNS therapies, I am delighted to drive the expansion of ClearPoints capabilities. I am eager to leverage their current pre-clinical and clinical portfolio, as well as to their pipeline of innovative tools on the horizon, to provide customized solutions to current and future ClearPoint pharmaceutical partners.

About ClearPoint Neuro

ClearPoint Neuros mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Companys current product portfolio include deep-brain stimulation, laser ablation, biopsy, neuro-aspiration, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 60 active clinical sites in the United States and the EU. The Companys SmartFlow cannula is being used in partnership or evaluation with 25 individual biologics and drug delivery companies in various stages from preclinical research to late-stage regulatory trials. To date, more than 4,000 cases have been performed and supported by the Companys field-based clinical specialist team which offers support and services for our partners. For more information, please visit http://www.clearpointneuro.com.

Forward-Looking Statements

Statements herein concerning the Companys plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to the impact of COVID-19 and the measures adopted to contain its spread; future revenues from sales of the Companys ClearPoint Neuro Navigation System products; the Companys ability to market, commercialize and achieve broader market acceptance for the Companys ClearPoint Neuro Navigation System products; and estimates regarding the sufficiency of the Companys cash resources. More detailed information on these and additional factors that could affect the Companys actual results are described in the Risk Factors section of the Companys Annual Report on Form 10-K for the year ended December 31, 2019, and the Companys Quarterly Report on Form 10-Q for the three months ended September 30, 2020, both of which have been filed with the Securities and Exchange Commission, and the Companys Annual Report on Form 10-K for the year ended December 31 2020, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2021.

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ClearPoint Neuro, Inc. Announces Expansion of Pre-Clinical and Translational Development Team to Support Gene and Stem Cell Therapy Partners -...

Global Cell Therapy Market 2020 by Company, Type and Application, Forecast to 2025 released at MarketQuest.biz offers widespread assessment and emphasizes fundamental synopsis of the global industry, embracing categorizations, applications, explanations, and manufacturing chain structure. The report discloses the overview of the market and then analyzes the market size (in terms of value and volume) and forecast by type, application/end-user, and region. The report contains a market competitive landscape and company profile between vendors, as well as market price analysis and value chain characteristics. The global Cell Therapy market research report sheds light on the assessment of its diverse segments and main geographies.

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

Competitors Analysis:

The competitive landscape offers a corresponding detailed analysis of the major vendors/manufacturers in the global Cell Therapy market. The report examined the key drivers influencing market growth, opportunities, challenges, and the risks faced by key players and the market. It also assesses key emerging trends and their impact on present and future development. This research study assists users to evaluate company shares analysis, emerging product lines, pricing strategies, innovation possibilities, and much more.

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The competitive terrain of the market, as per the report, is inclusive of numerous companies such as: Gilead Sciences, Beike Biotechnology, Vericel Corporation, Novartis, JCR Pharmaceuticals, Osiris, Guanhao Biotech, Fujifilm Cellular Dynamics, Vcanbio, Golden Meditech

In market segmentation by types, the report covers: Stem Cell, Non-Stem Cell

In market segmentation by applications, the report covers the following uses: Hospital, Clinic

Regionally, this report focuses on several key regions: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia, Italy, Spain, Benelux, Nordic), Asia (China, Japan, Korea, India, Southeast Asia, Australia and Taiwan), South America (Brazil, Argentina), MENA (Saudi Arabia, UAE, Turkey)

The report also specifies the computed expected CAGR of the market estimated on the basis of the existing and previous records concerning the global Cell Therapy market. Besides, the report covers various tactics to discover the weaknesses, opportunities, risks, and strengths having the potential to impact the global market expansion. The report helps to evaluate and understand the market and its applications on a global level.

Key Deliverables In The Study:

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Moreover, the report is assumed as the keeping source for market profitability in the research that is expected to raise the business potentials. In addition, the global Cell Therapy market report provides innovative strategies towards the SWOT study, examination of the industrial development. Also, the report delivers breakdown and data triangulation, consumer needs/customer preference change, research findings, market size estimation, and data source.

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Cell Therapy Market 2020 Industry Size, Share, Segmentation, Comprehensive Analysis and Forecast by 2025 KSU | The Sentinel Newspaper - KSU | The...

News Release

Thursday, January 28, 2021

Approach could provide new path for difficult-to-treat forms of Leber congenital amaurosis.

Scientists at the National Eye Institute (NEI) have developed a promising gene therapy strategy for a rare disease that causes severe vision loss in childhood. A form of Leber congenital amaurosis, the disease is caused by autosomal-dominant mutations in the CRX gene, which are challenging to treat with gene therapy. The scientists tested their approach using lab-made retinal tissues built from patient cells, called retinal organoids. This approach, which involved adding copies of the normal gene under its native control mechanism, partially restored CRX function. The study report appears today in Stem Cell Reports. NEI is part of the National Institutes of Health.

Our treatment approach, which adds more copies of the normal gene, could potentially treat autosomal-dominant LCA caused by a variety of mutations, said Anand Swaroop, Ph.D., chief of the NEI Neurobiology, Neurodegeneration and Repair Laboratory and senior author of the report.

The U.S. Food and Drug Administration approved Luxturna in 2017 for the treatment of LCA patients with mutations in a gene called RPE65. Although hailed as a major advance in gene therapy, Luxturna is ineffective against other forms of LCA, including those caused by autosomal-dominant mutations in CRX.

The CRX gene encodes a protein (also called CRX) that binds to DNA and instructs the retinas photoreceptors to make light-sensitive pigments called opsins. Without functional CRX protein, photoreceptors lose their ability to detect light and eventually die.

Disorders like autosomal-dominant LCA are tricky to treat with gene therapy, because adding more of the normal gene does not always restore function. People with autosomal-dominant mutations still have one normal copy of the gene, but the mutant version of the protein interferes with the normal protein. Sometimes, instead of restoring normal function, simply adding more of the normal protein can enhance the disease in unpredictable ways.

To explore how gene augmentation adding copies of the normal gene would affect autosomal-dominant LCA, Swaroops team, developed retinal organoids from two volunteers with LCA and from their unaffected family members. Led by Kamil Kruczek, Ph.D., a postdoctoral fellow in Swaroops lab, they built the complex retina-like tissues in several stages, starting with skin cells, inducing the production of mature photoreceptors and other retinal cells with the genetic profile of each volunteer. As expected, patient organoids made far less light-sensing opsin than the organoids made from unaffected family members.

To carefully control how much CRX gene would be expressed by the recipient photoreceptors, the team re-engineered the CRX promoter so it could be delivered with the CRX gene as part of the gene therapy. A promoter is a neighboring sequence of DNA that controls when and how genes are expressed. The researchers packed the gene and their engineered promoter inside a virus that shuttled them into the organoid photoreceptors.

The teams gene augmentation strategy restored some CRX protein function for organoids from both patients, driving expression of opsins in both types of photoreceptors: rods and cones.

The fact that this strategy worked for both CRX mutations was pretty exciting, said Swaroop. Gene augmentation may be a viable therapy for LCA caused by other autosomal-dominant mutations.

This proof-of-concept gene therapy study is the first step toward a potential treatment for a rare form of LCA, said Brian Brooks, M.D., NEI clinical director and co-author on the study. Its a great example of bench-to-bedside science, when researchers in basic and clinical science collaborate.

The current study was funded through the intramural programs of the NEI and the National Institute of Allergy and Infectious Diseases, both part of NIH. Patient samples were collected at the NIH Clinical Center, clinical trial number NCT01432847.

NEI has protected intellectual property around this technology which is available for licensing and or co-development. Details can be found on the NIH OTT Licensing website: Gene Therapy for Treatment of CRX-Autosomal Dominant Retinopathies | Office of Technology Transfer, NIH or by contacting NEI Office of Translational Research mala.dutta@nih.gov

Additional authors include: Zepeng Qu, James Gentry, Benjamin Fadl, Linn Gieser, Suja Hiriyanna, Zacahry Batz, Mugdha Samant, Ananya Samanta, Colin Chu, Laura Campello, and Zhijian Wu.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Kruczek K. Qu Z, Gentry J, Fadl BR, Gieser L, Hiriyanna S, Batz Z, Samant M, Samanta A, Chu CJ, Campello L, Brooks BP, Wu Z, and Swaroop A. Gene therapy of dominantCRX-Leber congenital amaurosis using patient stem cell-derived retinal organoids.Stem Cell Reports, January 28, 2020.https://doi.org/10.1016/j.stemcr.2020.12.018

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Researchers use patients' cells to test gene therapy for rare eye disease - National Institutes of Health

This report of the global , Stem Cell Therapy Market systematically focuses on various factors such as current and past situations, developments, noteworthy business skills, preferences, and player strategies directly chosen by key market players to ensure stable revenue generation and long-term stability. Sure probability. With this report, research analysts and industry experts also aim to provide ample light on additional essential determinants such as scrutiny review and assessment of opportunities for analysis, as well as the threats and challenges that continue to curb the growth spike in the Stem Cell Therapy Market. The report provides a useful overview highlighting various aspects that encourage conservative business decisions in the Stem Cell Therapys market.

The market scope segment provides revenue to the electronic equipment market, predicting significant growth and future of the market. Stem Cell Therapy Market separation breaks down the major sub-areas that make up the market. The weekly segmentation section provides the biological market size. The modest background explains the competitive nature of the market, the market dividends and the description of the major players. Significant financial transactions that have shaped the market over the past few years are recognized.

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Various workable inputs on ongoing market competition, growing intensity and relevant details about new product and technology development are included in the Stem Cell Therapy Market report. Additional details on M&A, commercial agreements and technology enhancements are also incorporated in the report. This section of the report draws attention towards competition analysis of the highlighted players and prominent vendors. Each of the mentioned players company and business overview with details on revenue generation, objectives and profit margin have been duly addressed in the report to encourage thoughtful business decisions amongst market aspirants as well as established players alike.

The report provides ample light on several market components such as key trends, ongoing challenges, as well as barriers and threats that significantly limit the growth of the global Stem Cell Therapy Market. This carefully written research report takes into account all the dominant regional and country-specific developments in the global Stem Cell Therapy Market. This report mainly focuses on key developments in North and South America, Europe, APAC and MEA regions

Complete Summary with TOC Available @ https://www.adroitmarketresearch.com/industry-reports/stem-cell-therapy-market?utm_source=re

Global Stem Cell Therapy Market 2020-26: Competitive Landscape Analytical Review

Compilation of this latest research report drives readers to have ongoing market developments, including paralyzing business and industrial development in numerous ways, including unprecedented advances such as the COVID-19 outbreak. The report is structured to highlight effective clues to growth-oriented business decisions, enabling manufacturers and stakeholders in the Stem Cell Therapy Market to come up with growth-friendly strategies and tactics.

Stem Cell Therapy Market Segmentation

Type Analysis of Stem Cell Therapy Market:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources

Applications Analysis of Stem Cell Therapy Market:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications

Systematic Guide to Report Investment

The report presents market size dimensions based on value and volume estimationsThe report demonstrates details on major dynamic alterations initiating growth diversionsThe report illustrates a touchpoint description of emerging segments and lucrative regional growth spots

What to expect from the Stem Cell Therapy Market report

1. The report investigates and makes the best forecasts related to market size and value estimation.2. A thorough evaluation to investigate material source and downstream purchasing development is reflected in the report.3. This report aims to characterize and segment the Stem Cell Therapy Market as a whole for the best reader understanding.4. Detailed references to buyer needs, barrier analysis and opportunity assessment are also taking root.

Market Report Highlights:

Chapter1. Executive SummaryChapter2. Research MethodologyChapter3. Stem Cell Therapy Market OutlookChapter4. Global Stem Cell Therapy Market Overview, By TypeChapter5. Global Stem Cell Therapy Market Overview, By ApplicationChapter6. Global Stem Cell Therapy Market Overview, By RegionChapter7. Company Profiles

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Stem Cell Therapy Market 2021 Industry Size, Trends, Global Growth, Insights And Forecast Research Report 2026 NeighborWebSJ - NeighborWebSJ

CAMBRIDGE, Mass., Jan. 29, 2021 /PRNewswire/ --Exacis Biotherapeutics, Inc., a development-stageimmuno-oncology company working to harness the immune system to cure cancer,today announcedthe addition of Dirk Huebner,MD,as its Chief Medical Officer. Exacis launched in 2020 to develop next generation mRNA-based cellular therapeutics to treat liquid and solid tumors.

Exacis CEO Gregory Fiore MD said, "Dirk is a wonderful addition and a great fit for our management team. His extensive experience in oncology drug development, including antibody related therapies will be instrumental as we build our pipeline to include high performance stealth edited NK and T cells, with and without CARs (ExaNK, ExaCAR-NK and ExaCAR-T). We look forward to Dirk's insights and medical leadership as we build the company and advance our portfolio."

Dr. Huebner joins Exacis from Mersana Therapeutics where he wasthe Chief Medical Officer,oversaw their clinical developmentand helped build thecompany'sclinical infrastructure. Dr Huebnerhas worked in oncology and immuno-oncology drug development and academiafor more than 25 yearsand brings a deep understanding of the needs in the oncology space as well as the ability to successfully deliverproducts to meet those needs.

Commenting on the new role, Dr. Huebner said, "I am thrilled to join the Exacis team and work with best-in-class technology to create innovative, next-generation engineered NK and T cell therapies that have the potential to improve outcomes and treatment experiences for patients with challenging hematologic and solid tumor malignancies."

About Exacis Biotherapeutics

Exacis is a development stageimmuno-oncologycompany focused on harnessing the human immune system to cure cancer. Exacis uses its proprietary mRNA-based technologies to engineer next generation off-the-shelf NK and T cell therapies aimed at liquid and solid tumors.Exacis was founded in 2020 with an exclusive license to a broad suite of patents covering the use ofmRNA-based cell reprogramming and gene editing technologiesfor oncology.

ExaNK, ExaCAR-NK and ExaCAR-T utilize mRNA cell reprogramming and mRNA gene editing technologies developed and owned by Factor Bioscience. Exacis has an exclusive license to the Factor Bioscience technology for engineered NK and T cell products derived from iPSCs for use in oncology and holds all global development and commercial rights for these investigational candidates.

About T and Natural Killer (NK) Cell Therapies

T and NK cells are types of human immune cells that are ableto recognize and destroy cancer cells and can be modified through genetic engineering to target specific tumors.

SOURCE Exacis Biotherapeutics, Inc.

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Exacis Biotherapeutics Announces Key Addition To Its Executive Leadership Team With Dirk Huebner MD Joining As Chief Medical Officer - PRNewswire

Initiation of the Phase 2b FREEDOM trial represents the next step in development of CLBS16 as a potential breakthrough treatment for the millions of sufferers of CMD in the U.S., most of whom are women

Patient enrollment underway atTheChrist Hospital Health Network in Cincinnati (OH) and Mayo Clinic in Rochester (MN) with additional sites across the United States targeted to open soon

Strong investigator and subject interest driven by the positive results of the Phase 2a ESCaPE-CMD trial reported in spring of 2020

BASKING RIDGE, N.J. (January 29, 2021) Caladrius Biosciences, Inc.,a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, announced that it has treated the first patient in its Phase 2b FREEDOM trial of CLBS16 as a therapy for coronary microvascular dysfunction (CMD) at TheChrist Hospital Health Network in Cincinnati, Ohio. The 105-patient double-blind and placebo-controlled clinical trial is designed to further evaluate the efficacy and safety of intracoronary delivery of autologous CD34+ cells (CLBS16) in subjects with CMD and without obstructive coronary artery disease.

We are very excited about our CLBS16 program as it represents a potential breakthrough in the treatment of CMD, a condition which afflicts millions of patients in the US alone, many of whom are women. As a result, CMD is a womens health issue of emerging importance as currently there are no products with approved labeling for coronary microvascular dysfunction, said David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius. The treatment of the first patient in the FREEDOM trial is an important milestone for our Company and the program and we look forward to completing enrollment by the target of year-end 2021. It is especially noteworthy that even during the COVID-19 pandemic, physicians and patients are active in our trial, denoting the seriousness of the disease and underscoring the lack of available effective treatment for CMD.

Following the outstanding full data results from the ESCaPE-CMD study that I presented at SCAI 2020, we are very excited to participate in the FREEDOM trial, said Timothy D. Henry, M.D., Medical Director of the Carl and Edyth Lindner Center for Research at TheChrist Hospital Health Network. Caladrius CLBS16 program has demonstrated great promise and I am looking forward to seeing how this new therapeutic option can benefit patients with CMD.

For more information on this study, please visitclinicaltrials.gov(identifier: NCT04614467).

If you are a patient or a physician and have questions about eligibility for this study, please visitwww.freedom-trial.com.

About Coronary Microvascular Dysfunction

Coronary microvascular dysfunction is a type of non-obstructive coronary artery disease that causes decreased blood flow to the heart muscle that affects approximately 8.3 million people in the U.S.1,2With common symptoms that include recurring, debilitating chest pain, tiredness, and shortness of breath, many CMD patients are undiagnosed because of the absence of large vessel obstruction. Due to an under appreciation of the disease, patients, the majority of whom are women, often go years without proper treatment. When a diagnosis of CMD is missed, patients are untreated and remain at high risk of heart attack and/or cardiovascular-related death._______________________[1] Mittal, S.R.; Indian Heart Journal, Volume 66, 2014, Pages 678681[2] Cleveland Clinic/AHA (American Heart Association)

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease. We are developing first-in-class cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. 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: 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; OLOGO (formerly 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); CLBS16, the subject of both a recently completed positive Phase 2a study and a newly initiated Phase 2b study in the U.S. for the treatment of coronary microvascular dysfunction (CMD); CLBS119, an emergent CD34+ stem cell therapy responding to the COVID-19 pandemic and the potentially permanent damage the virus inflicts on the lungs of many patients; and CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for chronic kidney disease (CKD). For more information on the company, please visitwww.caladrius.com.

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Caladrius Biosciences Treats First Patient in the Phase 2b FREEDOM Trial of CLBS16 for the Treatment of Coronary Microvascular Dysfunction - Cath Lab...

METUCHEN, N.J., Jan. 25, 2021 /PRNewswire/ -- Tevogen Bio today announced it has secured necessary funding from HMP Partners of New Jersey, an investment firm managed by medical doctors, which will allow Tevogen to support all clinical trials of its investigational, potentially curative COVID-19 treatment. Tevogen's Investigational New Drug (IND) application for its proprietary antigen-specific T cell therapy is under review by the U.S. Food and Drug Administration (FDA).

All COVID-19 therapeutics utilized to date have sought to slow the progression of the infection and/or moderate its symptoms. These approaches buy time for the patient's own T cells to activate and respond to the infection, which is the mechanism that the body employs to rid itself of viruses such as the SARS-CoV-2.

In the upcoming trials, Tevogen will study its investigational treatment, TVGN-489, allogeneic T cells that have been programmed and grown in the laboratory, for its safety and capability to recognize and destroy COVID-19 infected cells. Lead investigator Dr. Neal Flomenberg, Chair of the Department of Medical Oncology at Thomas Jefferson University, stated his optimism, "We're excited by the purity and potency of the cells we've been able to generate in the lab. Based on prior experience with these sorts of cells in other settings, we're very hopeful that they will be both safe and effective when the clinical trials are launched."

HMP Partners is supporting Tevogen's efforts to develop a curative treatment due to concerns over recent COVID-19 mutations and the current lack of curative options for this deadly infection. HMP CEO Dr. Manmohan Patel, a prominent pulmonary and critical care specialist, said, "We believe it's imperative to create a curative treatment that is not expected to be compromised by mutations." He added, "Unmodified virus specific T cells are well established as being effective and safe at treating viral infections, which is why we are supporting Tevogen's efforts to develop a much-needed COVID-19 cure."

While Tevogen has raised private investment from HMP Partners to launch its clinical trials, the company is seeking government funding to expedite capacity to manufacture at the scale necessary to develop pandemic-level product supply, just as have a number of vaccine and antibody manufacturers.

Tevogen's proprietary solution is designed to enable a single donation from a donor to generate more than a thousand doses of COVID-19 specific cytotoxic T cells.Yale-trained infectious disease epidemiologist Dr. Ryan Saadi is leading Tevogen's efforts and is among those who are financing the trials. Dr. Saadi stated, "We halted our pursuit for an oncology cure in order to focus solely on COVID-19, and our manufacturing efficiencyand agile business model will allow us to deliver a cure that will be affordable and accessible to all."

About Tevogen Bio

Tevogen Bio was formed after decades of research by its contributors to concentrate and leverage their expertise, spanning multiple sectors of the healthcare industry, to help address some of the most common and deadly illnesses known today. The company's mission is to provide curative and preventative treatments that are affordable and scalable, in order to positively impact global public health.

About HMP Partners

HMP Partners of New Jersey is a consortium of medical doctors who are dedicated to supporting the advancement of potentially life-saving technologies. HMP CEO Dr. Manmohan Patel, a prominent pulmonary and critical care specialist, has nearly 50 years of medical expertise in a diverse field of specialties, including pulmonary, internal, geriatric and emergency medicine as well as critical care. Dr. Patel's commitment to community and medical management is demonstrated by his distinguished appointments, including serving as the Director of Post Cardiac Surgery at Saint Michael's Medical Center in Newark, NJ and as Chairman of the Department of Medicine at Meadowlands Hospital Medical Center in Secaucus, NJ. In 2000, he was appointed by the Governor of New Jersey to the Board of Medical Examiners Executive Committee for the state and served on various other committees, including reviewing malpractice actions, in that capacity.

About Dr. Neal Flomenberg

Dr. Neal Flomenberg is the Chairman of the Department of Medical Oncology and Deputy Director of the Sidney Kimmel Cancer Center at Jefferson University in Philadelphia.Dr. Flomenberg launched Jefferson's Blood and Marrow Transplantation (BMT) Program in 1995. Throughout his four decades of practice, he has maintained a longstanding interest in the immunogenetics and immunology of stem cell transplantation, with the goal of making transplantation safer and more widely available. He is board certified in the fields of internal medicine, hematology, and medical oncology.

Media Contacts:

Mark Irion

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Katelyn Petroka[emailprotected]

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Tevogen Bio Secures Funding from Team of Doctors to Support Clinical Trials of Its Investigational Curative T Cell Therapy for COVID-19 - PRNewswire

Scientists have identified a protein that can slow or stop some signs of Parkinsons disease in mice.

The team found that the bone morphogenetic proteins 5 and 7 (BMP5/7) can have these effects in a mouse model of the disease.

This research, which appears in the journal Brain, may be the first step toward developing a new treatment for Parkinsons disease.

This type of brain disorder typically affects people over the age of 60, and the symptoms worsen with time.

Common symptoms include stiffness, difficulty walking, tremors, and trouble with balance and coordination.

The disease can also affect the ability to speak and lead to mood changes, tiredness, and memory loss.

Parkinsons Foundation report that about 1 million people in the United States had the disease in 2020, with about 10 million affected globally.

Despite this prevalence, scientists are still unsure why Parkinsons disease affects some people and not others, and there is currently no cure.

The National Institute on Aging note that some cases of Parkinsons disease seem to be hereditary. In other words, the disease can emerge in different generations of a family but for many people with the disease, there appears to be no family history.

Researchers believe that multiple factors may affect a persons risk, including genetics, exposure to environmental toxins, and age.

Since there is currently no cure for Parkinsons disease, treatments typically focus on alleviating its symptoms.

Existing treatments can help alleviate of Parkinsons disease, such as stiffness. However, they may work less well, or not work, for others, such as tremors or a loss of coordination.

Though researchers are still unsure why some develop the disease and others do not, they understand what occurs in the brain of a person with Parkinsons.

The disease causes the neurons in the part of the brain that controls movement to stop working or die. The brain region, therefore, produces less of the chemical dopamine, which helps a person maintain smooth, purposeful movement, as the National Institute of Neurological Disorders and Stroke observe.

Also, Lewy bodies occur in the brains of some people with Parkinsons disease. These bodies are clumps primarily made up of misfolded forms of the protein alpha-synuclein.

In their recent study paper, the scientists refer to research suggesting that neurotrophic factors molecules that help neurons survive and thrive could, in theory, restore the function of neurons that produce dopamine. However, the clinical benefit of these factors had yet to be proven.

The team focused on bone morphogenetic proteins 5 and 7 (BMP5/7). They had previously shown that BMP5/7 has an important role in dopamine-producing neurons in mice.

In the latest study, the scientists wanted to see whether BMP5/7 could protect the neurons of mice against the damaging effects of misfolded alpha-synuclein proteins.

To do this, they injected one group of mice with a viral vector that caused misfolded alpha-synuclein proteins to form in their brains. They used other mice as a control group. The scientists then injected the mice with the BMP5/7 protein.

The researchers found that the BMP5/7 protein had a significant protective effect against the misfolded alpha-synuclein proteins.

According to senior study author Dr. Claude Brodski, of the Israel-based Ben-Gurion University of the Negevs Department of Physiology and Cell Biology, We found that BMP5/7 treatment can, in a Parkinsons disease mouse model, efficiently prevent movement impairments caused by the accumulation of alpha-synuclein and reverse the loss of dopamine-producing brain cells. He continues:

These findings are very promising, since they suggest that BMP5/7 could slow or stop Parkinsons disease progression. Currently, we are focusing all our efforts on bringing our discovery closer to clinical application.

The universitys technology transfer company, BGN Technologies, is currently looking to bring the development to the market.

Dr. Galit Mazooz-Perlmuter, the companys senior vice president of bio-pharma business development, notes that There is a vast need for new therapies to treat Parkinsons disease, especially in advanced stages of the disease.

Dr. Brodskis findings, although still in their early stages, offer a disease-modified drug target that will address this devastating condition. We are now seeking an industry partner for further development of this patent-pending invention.

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Protein identified that may help treat Parkinsons disease - Medical News Today

Nine abstracts accepted demonstrating potential of HSC gene therapy to treat multiple neurodegenerative disorders

New clinical data from all eight patients treated with OTL-203 for Mucopolysaccharidosis type I (MPS I)

Biomarker data from first three patients treated with OTL-201 for Mucopolysaccharidosis type IIIA (MPS-IIIA or Sanfilippo Syndrome Type A)

Multiple abstracts highlighting clinical and real-world data for OTL-200 and Metachromatic Leukodystrophy (MLD)

Company to host virtual investor webinar to review symposium data on Tuesday, February 9, 2021 at 4:30 p.m. ET

BOSTON and LONDON, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Orchard Therapeutics(Nasdaq: ORTX), a global gene therapy leader, today outlined nine upcoming presentations from its neurodegenerative portfolio to be featured at the 17th Annual WORLDSymposium being held on February 8-12, 2021. Accepted abstracts include clinical data from three of its hematopoietic stem cell (HSC) gene therapy programs OTL-200 for MLD, OTL-203 for MPS-I and OTL-201 for MPS-IIIA as well as data supporting Orchards multi-pronged patient identification and market access strategies for eligible MLD patients in Europe.

Together with our clinical partners, were proud of our presence at the upcoming WORLDSymposium, which for the first time features clinical data on cognitive function and growth in all eight MPS-I patients treated with gene therapy, said Bobby Gaspar, M.D., Ph.D., chief executive officer of Orchard. Alongside emerging data in MPS-IIIA and our extensive body of clinical and real-world data in MLD, our programs are establishing a clear picture of the transformative potential of HSC gene therapy across multiple fatal neurodegenerative conditions.

The presentations are listed below and the full preliminary program is available online on the WORLDSymposium website. The ePosters will open at 2:30 p.m. ET on Monday, February 8, 2021 and will remain open throughout WORLDSymposium 2021.

Orchard is planning to host a virtual investor webinar on Tuesday, February 9th, 2021 at 4:30 p.m. ET to review the data from its neurodegenerative programs presented at the WORLDSymposium. A live webcast will be available under Events in the Investors & Media section of the companys website at http://www.orchard-tx.com and a replay of the webcast will be archived following the event.

Platform Oral Presentation Details:

Ex-vivo autologous stem cell gene therapy clinical trial for mucopolysaccharidosis type IIIA: Update on phase I/II clinical trialPresenting Author: Jane Kinsella, Royal Manchester Childrens Hospital 2021 Young Investigator Award RecipientDate/Time: Tuesday, February 9, 2021, 11:12 a.m. ET

Ex vivo hematopoietic stem cell gene therapy for mucopolysaccharidosis type I (Hurler syndrome)Presenting Author: Bernhard Gentner, San Raffaele Telethon Institute for Gene TherapyDate/Time: Tuesday, February 9, 2021, 11:24 a.m. ET

Lentiviral hematopoietic stem and progenitor cell gene therapy provides durable clinical benefit in early-symptomatic early juvenile metachromatic leukodystrophyPresenting Author: Francesca Fumagalli, San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific InstituteDate/Time: Wednesday, February 10, 2021, 11:36 a.m. ET

ePoster Presentation Details:

Lentiviral haematopoietic stem cell gene therapy for metachromatic leukodystrophy: Results in nine patients treated with a cryopreserved formulation of OTL-200Abstract Number: 25Presenting Author: Valeria Calbi, San Raffaele Telethon Institute for Gene TherapyDate/Time: Wednesday, February 10, 2021, 2:30 3:30 p.m. ET

Initial signs and symptoms of metachromatic leukodystrophy: A caregiver perspectiveAbstract Number: 64Presenting Author: Florian Eichler, Massachusetts General HospitalDate/Time: Thursday, February 11, 2021, 2:30 3:30 p.m. ET

Demographic and clinical characteristics of patients with metachromatic leukodystrophy in the United Kingdom: Interim results from an observational real-world studyAbstract Number: 110Presenting Author: Simon Jones, Manchester Centre for Genomic Medicine Date/Time: Thursday, February 11, 2021, 2:30 3:30 p.m. ET

Quality of life of patients with metachromatic leukodystrophy and their caregivers in the US, UK, Germany and FranceAbstract Number: 186Presenting Author: Francis Pang, Orchard TherapeuticsDate/Time: Thursday, February 11, 2021, 2:30 3:30 p.m. ET

Health-related quality of life in metachromatic leukodystrophy based on a societal utility study in the UKAbstract Number: 187Presenting Author: Francis Pang, Orchard TherapeuticsDate/Time: Thursday, February 11, 2021, 2:30 3:30 p.m. ET

Newborn screening for metachromatic leukodystrophy in Northern Germany - a prospective studyAbstract Number: 269Presenting Author: Thomas Wiesinger, ARCHIMEDlifeDate/Time: Thursday, February 11, 2021, 2:30 3:30 p.m. ET

About Libmeldy / OTL-200Libmeldy (autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human arylsulfatase-A (ARSA) gene), also known as OTL-200, has been approved by the European Commission for the treatment of MLD in eligible early-onset patients characterized by biallelic mutations in the ARSA gene leading to a reduction of the ARSA enzymatic activity in children with i) late infantile or early juvenile forms, without clinical manifestations of the disease, or ii) the early juvenile form, with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline. Libmeldy is the first therapy approved for eligible patients with early-onset MLD.

The most common adverse reaction attributed to treatment with Libmeldy was the occurrence of anti-ARSA antibodies. In addition to the risks associated with the gene therapy, treatment with Libmeldy is preceded by other medical interventions, namely bone marrow harvest or peripheral blood mobilization and apheresis, followed by myeloablative conditioning, which carry their own risks. During the clinical studies, the safety profiles of these interventions were consistent with their known safety and tolerability.

For more information about Libmeldy, please see the Summary of Product Characteristics (SmPC) available on the EMA website.

Libmeldy is not approved outside of the European Union, UK, Iceland, Liechtenstein and Norway. OTL-200 is an investigational therapy in the US.

Libmeldy was developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy.

About OrchardOrchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSKs rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and theSan Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit http://www.orchard-tx.com, and follow us on Twitter and LinkedIn.

Availability of Other Information About OrchardInvestors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (Twitter andLinkedIn), including but not limited to investor presentations and investor fact sheets,U.S. Securities and Exchange Commissionfilings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-Looking StatementsThis press release contains certain forward-looking statements about Orchards strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include express or implied statements relating to, among other things, Orchards business strategy and goals, and the therapeutic potential of Orchards product candidates, including the product candidate or candidates referred to in this release. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation: the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchards product candidates, will be insufficient to support regulatory submissions or marketing approval in the US or EU, as applicable, or that long-term adverse safety findings may be discovered; the risk that any one or more of Orchards product candidates, including the product candidates referred to in this release, will not be approved, successfully developed or commercialized; the risk of cessation or delay of any of Orchards ongoing or planned clinical trials; the risk that Orchard may not successfully recruit or enroll a sufficient number of patients for its clinical trials; the delay of any of Orchards regulatory submissions; the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchards product candidates or the receipt of restricted marketing approvals; the inability or risk of delays in Orchards ability to commercialize its product candidates, if approved, or Libmeldy in the EU; the risk that the market opportunity for Libmeldy, or any of Orchards product candidates, may be lower than estimated; and the severity of the impact of the COVID-19 pandemic on Orchards business, including on clinical development, its supply chain and commercial programs. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchards quarterly report on Form 10-Q for the quarter endedSeptember 30, 2020, as filed with theU.S. Securities and Exchange Commission(SEC), as well as subsequent filings and reports filed with theSEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Contacts

InvestorsRenee LeckDirector, Investor Relations+1 862-242-0764Renee.Leck@orchard-tx.com

MediaChristine HarrisonVice President, Corporate Affairs+1 202-415-0137media@orchard-tx.com

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Orchard Therapeutics Outlines Comprehensive Presence at 2021 WORLDSymposium - GlobeNewswire

Animal Stem Cell Therapy Marketresearch report is the new statistical data source added byA2Z Market Research.

Animal Stem Cell Therapy Market is growing at a High CAGR during the forecast period 2021-2027. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market.

Animal Stem Cell Therapy Marketresearch is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share and contact information are shared in this report analysis.

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Top Key Players Profiled in this report are:

ANIMAL CELL THERAPIES, Celavet, Animacel, VETSTEM BIOPHARMA, Cell Therapy Sciences, Magellan Stem Cells, Cells Power Japan, Animal Care Stem, Aratana Therapeutics, VetCell Therapeutics, MediVet Biologic, U.S. Stem Cell, J-ARM

The key questions answered in this report:

Various factors are responsible for the markets growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Animal Stem Cell Therapy market. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market. The influence of the latest government guidelines is also analyzed in detail in the report. It studies the Animal Stem Cell Therapy markets trajectory between forecast periods.

Global Animal Stem Cell Therapy Market Segmentation:

Market Segmentation: By Type

DogsHorsesOthers

Market Segmentation: By Application

Veterinary HospitalsResearch Organizations

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Regions Covered in the Global Animal Stem Cell Therapy Market Report 2021:The Middle East and Africa(GCC Countries and Egypt)North America(the United States, Mexico, and Canada)South America(Brazil etc.)Europe(Turkey, Germany, Russia UK, Italy, France, etc.)Asia-Pacific(Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

The cost analysis of the Global Animal Stem Cell Therapy Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.

The report provides insights on the following pointers:

Market Penetration:Comprehensive information on the product portfolios of the top players in the Animal Stem Cell Therapy market.

Product Development/Innovation:Detailed insights on the upcoming technologies, R&D activities, and product launches in the market.

Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market.

Market Development:Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies.

Market Diversification:Exhaustive information about new products, untapped geographies, recent developments, and investments in the Animal Stem Cell Therapy market.

Table of Contents

Global Animal Stem Cell Therapy Market Research Report 2021 2027

Chapter 1 Animal Stem Cell Therapy Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6 Global Production, Revenue (Value), Price Trend by Type

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10 Marketing Strategy Analysis, Distributors/Traders

Chapter 11 Market Effect Factors Analysis

Chapter 12 Global Animal Stem Cell Therapy Market Forecast

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The company helps clients build business policies and grow in that market area. A2Z Market Research is not only interested in industry reports dealing with telecommunications, healthcare, pharmaceuticals, financial services, energy, technology, real estate, logistics, F & B, media, etc. but also your company data, country profiles, trends, information and analysis on the sector of your interest.

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Comprehensive Report on Animal Stem Cell Therapy Market 2021 | Size, Growth, Demand, Opportunities & Forecast To 2027 | ANIMAL CELL THERAPIES,...

Avery Therapeutics is projected to be one of the first companies in the US to seek approval for a clinical trial using iPSC-derived technology for heart failure. The goal of this collaboration is to develop a new off-the-shelf treatment to improve the quality of life of patients suffering from heart failure, a debilitating disease that affects tens of millions of people worldwide.

The iPSCs are manufactured at I Peace's state-of-the-art GMP facility in Kyoto, Japan, under comprehensive validation programs of the facility, equipment, and processes including donor recruiting, screening, blood draw, iPSC generation, storage, and distribution. I Peace has obtained a US-based independent institutional review board (IRB) approval for its process of donor sourcing for commercial-use iPSCs. The facility is designed to be PMDA and USFDA compliant.

As Avery Therapeutics expects to expand the application of its regenerative medicine technology to various types of heart diseases and beyond, iPSCs are the key enabling technology for quality and future scalability. This agreement provides a solid foundation to improve the welfare of those suffering from diseases through advancement of tissue-engineered therapeutics.

"We are thrilled to announce this collaboration with I Peace. It is a big step forward in the development of novel cell-based therapeutics for unmet medical needs. Through this collaboration, I Peace brings deep iPSC development and manufacturing expertise to enable Avery's proprietary MyCardia cell delivery platform technology. Together we hope to positively impact millions of patients worldwide in the near future," Said Jordan Lancaster, PhD, Avery Therapeutics' CEO.

This agreement reflects an innovative collaboration involving multiple locations internationally and marks a significant milestone for both I Peace, Inc. and Avery Therapeutics to pursue one of the first US clinical trials using iPSC technology in the area of heart diseases. Koji Tanabe, PhD, founder and CEO of I Peace stated: "By combining I Peace's proprietary clinical grade iPSC technology and Avery's tissue engineering technology, we can bring the regenerative medicine dream closer to reality. We are very excited by Avery's technology and look forward to continue working together."

About I Peace, Inc

I Peace, Inc. is a global supplier of clinical and research grade iPSCs. It was founded in 2015 in Palo Alto, California, USA by Dr. Tanabe, who earned his doctorate at Kyoto University under Nobel laureate Dr. Shinya Yamanaka. I Peace's mission is to alleviate the suffering of diseased patients and help healthy people maintain a high quality of life by making cell therapy accessible to all. I Peace's state-of-the-art GMP facility and proprietary manufacturing platform enables the fully-automated mass production of discrete iPSCs from multiple donors in a single room. Increasing the available number of clinical-grade iPSC lines allows I Peace customers to take differentiation propensity into account to select the most appropriate iPSC line for their clinical research at significantly reduced cost. I Peace aims to create iPSCs for every individual that become their stem cell for life.

Founder, CEO: Koji TanabeSince: 2015Head Quarter: Palo Alto, CaliforniaJapan subsidiary: I Peace, Ltd. (Kyoto, Japan)Cell Manufacturing Facility: Kyoto, JapanWeb: https://www.ipeace.com

About Avery Therapeutics

Avery Therapeutics is a company developing advanced therapies for patients suffering from cardiovascular diseases. Avery's lead candidate is an allogeneic tissue engineered cardiac graft, MyCardia in development for treatment of chronic heart failure. Using Avery's proprietary manufacturing process MyCardia can be manufactured at scale, cryopreserved, and shipped ready to use. Avery is leveraging its proprietary tissue platform to pursue other cardiovascular indications. For more information visit: AveryThera.com. Follow Avery Therapeutics on LinkedInand Twitter.Since: 2016Headquarter: Tucson, AZWebsite: https://www.AveryThera.com

SOURCE I Peace, Inc.

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I Peace, Inc. and Avery Therapeutics announce collaboration to bring iPSC derived cell therapy for heart failure to the clinic - PRNewswire

PHOENIX, Dec. 16, 2020 /PRNewswire/ --Creative Medical Technology Holdings Inc., (OTC CELZ) announced today positive preclinical data supporting the utilization of its ImmCelz cell based immunotherapy for treatment of stroke. In an animal model of ischemia stroke, the middle cerebral artery ligation model, administration of ImmCelz resulted in 34% reduction in infarct volume, whereas control bone marrow mesenchymal stem cells reduced infarct volume by 21%. Additionally, improvements in functional recovery where observed using the Rotarod test. At 28 days after induction of stroke the animals receiving ImmCelz had superior running time (92% of non-stroke controls) compared to animals which received bone marrow mesenchymal stem cells (73% of non-stroke control). Animals that received saline had a running time that was 50% of non-stroke controls.

"The regenerative potential of immune cells that have been programmed by stem cells is a fascinating and novel area of research." Said Dr. Amit Patel, coinventor of ImmCelz, and board member of the Company. "Conceptual advantages of using reprogrammed T cells include higher migratory ability due to smaller size, as well as ability to replicate and potentially form "regenerative memory cells."

"This data, which is covered by our previous filed patents, such as no. 15/987739, Generation of autologous immune modulatory cells for treatment of neurological conditions, demonstrate that immune modulation via this stem cell based method may be a novel and superior way of addressing the $30 billion dollar market for stroke therapeutics1." Said Dr. Thomas Ichim, coinventor of the patent and Chief Scientific Officer of the Company. "The fact that this technology, which has priority back to 2017, is demonstrating such stunning results, motivates us to consider filing an Investigational New Drug Application for use in stroke."

Creative Medical Technology Holdings possesses numerous issued patents in the area of cellular therapy including patent no. 10,842,815 covering use of T regulatory cells for spinal disc regeneration, patent no. 9,598,673 covering stem cell therapy for disc regeneration, patent no. 10,792,310 covering regeneration of ovaries using endothelial progenitor cells and mesenchymal stem cells, patent no. 8,372,797 covering use of stem cells for erectile dysfunction, and patent no. 7,569,385 licensed from the University of California covering a novel stem cell type.

"While stroke historically has been a major area of unmet medical need, the rise in stroke cases , as well as the fact that younger people are increasingly falling victim to stroke, strongly motivates us to accelerate our developmental programs and to continue to explore participation of Big Pharma in this space." Said Timothy Warbington, President and CEO of the Company. "We are eager to replicate the existing experiments start compiling the dossier needed to take ImmCelz into humans using the Investigational New Drug Application (IND) route through the FDA."

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in stem cell technology in the fields of urology, neurology and orthopedics and trades on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website atwww.sec.gov.

Timothy Warbington, CEO[emailprotected] CreativeMedicalHealth.com

Creativemedicaltechnology.comwww.StemSpine.comwww.Caverstem.comwww.Femcelz.com

1 Stroke Management Market Size Forecasts 2026 | Statistics Report (gminsights.com)

SOURCE Creative Medical Technology Holdings, Inc.

http://creativemedicaltechnology.com

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Creative Medical Technology Holdings Announces Successful Application of ImmCelz Immunotherapy for Treatment of Stroke - PRNewswire

OSS, Netherlands, Dec. 17, 2020 /PRNewswire/ --Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, and Ghent University (UGent) have signed a license agreement for an innovative NK cell production technology. Ultimately, this agreement will bring significant benefit to targeted treatment of patients suffering from cancer. The agreement not only opens up new opportunities for development of NK-antibody combination therapies but also has significant positive impact on the production time of Glycostem's lead product oNKord and its second (CAR-NK) and third (TCR-NK) generation therapies viveNKTM.

"This license agreement offers new opportunities for more targeted treatment of cancer patients. By using UGent's technology we are able to increase the expression of CD16 receptors resulting in an increase of the NK-cell's activity and its antibody binding properties. When a patient's immunity is weak, administering NK-cells will boost the patient's immune system and increase the antibody's therapeutic effectiveness," explains Troels Jordansen, CEO at Glycostem.

Glycostem's NK-cell based therapies are manufactured in its in-house GMP licensed facility. "Ghent University's technology has the potential to almost halve the time needed for NK cell progenitor cells to differentiate into fully functional NK-cells. By incorporating this in our processes both our manufacturing time and cost-effectiveness will be affected very positively without negative effect on the potency of the NK cells. This is an important part of paving the way for further upscaling the production of our NK-cells," says Troels Jordansen.

"We are glad to see our research translated to a clinical setting as it is based on many years of fundamental research into NK cell biology," tells Prof. Georges Leclercq, head of the UGent research team and group leader in the Cancer Research Institute Ghent (CRIG). "We hope that with this collaboration, we can positively impact the lives of many patient's affected by difficult to treat cancers."

Dr. Dominic De Groote (UGent Business Development) further explains: "This partnership is the result of continuing efforts by Ghent University and Ghent University Hospital to become a leading academic and clinical center for cell-based therapies. This technology is part of our growing portfolio of oncology and Advanced Therapy Medicinal Products (ATMP) related assets that we are actively developing from the bench to the bedside through our translational platforms."

Taking cellular immunotherapy to the next level

Glycostem is focused on developing first, second and third generation cancer treatments based on NK-cells. This licensing deal will affect Glycostem's full portfolio. After a successful phase I study Glycostem initiated a first-of-its-kind pivotal trial in acute myeloid leukemia (AML) with in-house manufactured nonmodified NK cells (oNKord). Over the coming months, AML patients will receive this form of treatment as part of a phase I-IIa trial. A pivotal phase IIa trial for Multiple Myeloma (MM) patients is expected to start second half of 2021. This makes Glycostem one of the frontrunners in this promising field of cellular immunotherapy.

About Glycostem

Netherlands-based Glycostem Therapeutics BV, a clinical stage biotech company, develops allogeneic cellular immunotherapy to treat several types of cancer. By harnessing the power of stem cell-derived Natural Killer (NK) cells, Glycostem's products are a safe alternative to CAR-T-cells. Glycostem's lead product, oNKord, is manufactured from allogeneic raw material and is available off-the shelf. Thanks to its nine patent families, longstanding technical expertise and resources, as well as 'Orphan Drug Designation', Glycostem has secured a leadership position in the global NK-cell market.

oNKord is produced in a closed system (uNiKTM) in Glycostem's state-of-the-art and GMP (Good Manufacturing Practice) licensed production facility in the Netherlands, from which it can be distributed globally. The production technology includes ex vivo generation of high numbers of NK-cells with a high degree of purity for clinical applications. oNKord successfully passed phase I clinical trial (elderly and frail AML - Acute Myeloid Leukemia - patients), providing solid safety data and strong indication of clinical activity, including response on MRD (Minimal Residual Disease). Results indicate that oNKord may be safely infused in AML patients.

Glycostem is furthermore developing a range of CAR-NK and TCR-NK products in-house and in cooperation with global partners.

Glycostem Therapeutics BV http://www.glycostem.com

Foot note: "oNKord" is a registered trademark of Glycostem in the US and in Europe. Trademark registrations of "viveNK" and "uNiK" are pending.

About Ghent University

Ghent University (UGent) is a major Belgian university located in the heart of Europe. Our organization is dedicated to research and innovation with over 5,500 researchers active in a wide area of life, physical and social sciences. Strong partnerships with the Ghent University Hospital (1000+ beds), VIB, IMEC and global leaders in academia and pharma/biotech industry thrive life science innovation at our university and is part of the thriving Belgian biotech region. Our translational platforms such as CRIG (focus on cancer) and GATE (focus on advanced therapy medicinal products) facilitate to bring science to the patient.

Prof. Georges Leclercq has a longstanding and internationally recognized expertise in differentiation and function of NK cells. The recent focus of his research group is to reveal the role of several transcription factors in the differentiation of human hematopoietic stem cells into mature NK cells, and in the maintenance and function of these mature NK cells. The ultimate aim is to attribute to improved NK-based cancer immunotherapy.

Cancer Research Institute Ghent http://www.crig.ugent.be

SOURCE Glycostem

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Glycostem and Ghent University sign license agreement on NK cell therapy technology - PRNewswire

The latest version of the 2020 market study on Stem Cell Therapy Market comprising 104 with market data Tables, Charts, Graphs, and Figures which are easy to understand with showcased in-depth analysis.

The Coronavirus Pandemic (COVID-19) has affected every aspect of life worldwide. This has led to several changes in market conditions. The report covers the rapidly changing market scenario and the initial and future impact assessments.

The global Stem Cell Therapy market was valued at $XX million in 2019, and Research analysts predict the global market size will reach $XX million by the end of 2029, growing at a CAGR of XX% between 2020 and 2029.

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As per the research and study, the market has settled its presence worldwide. Stem Cell Therapy Market Research study offers a comprehensive evaluation of the Market and comprises a future trend, current growth factors, focused opinions, details, and industry certified market data.

Glancing to 2020, the global market expected to be a significant year for Stem Cell Therapy Market in terms of growth and revenue.

Almost all companies who are listed or profiled are being to upgrade their applications for end-user experience and setting up their permanent base in 2020. This report focused and concentrate on these companies including Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCR Pharmaceutical, Pharmicell, Medi-post, Anterogen, Molmed, Takeda (TiGenix).

Furthermore, the research contributes an in-depth overview of regional level break-up categorized as likely leading growth rate territory, countries with the highest market share in past and current scenario. Some of the geographical break-up incorporated in the study are North America (United States, Canada and Mexico), Europe (Germany, UK, France, Italy, Russia and Spain etc.), Asia-Pacific (China, Japan, Korea, India, Australia and Southeast Asia etc.), South America (Brazil, Argentina and Colombia etc.), Middle East & Africa (South Africa, UAE and Saudi Arabia etc.).

With the Stem Cell Therapy market forecast to expand CAGR% in 2020 and with X-X-X-X supposed to be a big beneficiary, it is better positioned than Z-Z-Z-Z for 2020.

According to the AMR market study, Recent trends in consumer preferences market segments such as type, the application will be more challenging. Stem Cell Therapy market segment sales will traverse the $$ mark in 2020.

Unlike classified segments successful in the industry such as by Type (Autologous, Allogeneic) and by End-Users/Application (Musculoskeletal Disorder, Wounds & Injuries, Cornea, Cardiovascular Diseases, Others).

The 2020 version of the Stem Cell Therapy market study is a further split down / narrowed to highlight the latest emerging twist of the industry.

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Due to a change in consumer preferences with a review on the latest sales and revenue report submissions, Major vendors in the Global market are trying to get the attention of end-users or consumers by Offerings and additional services.

With using the latest technology and analysis on demand-side, Key players are getting in consumer behavior and their changing preferences.

Again, big investment firms or giants are willing to put more capital to get a key players performance in the market for new applications or products.

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Stem Cell Therapy Market to See Massive Growth by 2026 Osiris Therapeutics, NuVasive - Farming Sector

Researchersarepoised to makeunprecedentedbreakthroughsinhuman health thanks toadvancesin biomedical and computational sciencesthathave drivencritical tools and technologiessuch as genetic engineering,synthetic biology, andartificial intelligence.

Thats the messageDr. VictorDzau, president oftheU.S.National Academy ofMedicine, delivered to Medicine by Designs fifthannual symposium on Dec. 7 and 8.

Thevirtual event, whichattracted more than 500 registrants from across North America, focused on the theme of better science throughconvergence theintegration of approaches from engineering, science, medicine and other fields to expand knowledge and spark innovation.

I think for younger people, there is really not a more exciting time, in my opinion, to do research than now, because we can really see that some of the initial concepts that people have about health and medicinecan be realizedand truly transform the way we do health andmedicine.

In his talk, Dzau focused on the National Academy of MedicinesHealthy Longevity Global Challenge,an international competition that aims to catalyze transformative ideas and breakthroughs that will extend human healthand lifespan.

That program is one of the inspirations for Medicine by DesignsGrand Questions Program, which seeks to fund bold research that promises dramatically better health outcomes by changing the future of regenerative medicine.

Through our Grand Questions Program, we are thinking about what comes next and how to overcome fundamental problems in regenerative medicine,saidMichael Sefton, executive director of Medicine by Design andUniversity Professorin the department of chemical engineering and applied chemistry and theInstitute of Biomedical Engineeringat the University of Toronto.

We have a broad definition of regenerativemedicine, andpreventing degeneration can be as important as the next cell therapy.

Sefton pointed out that the symposium theme of better science through convergencefocusedon a key aspect of Medicine by Design:That we combine campus and hospital investigators, transformative science and translational elements, junior and senior investigators, and local and international collaborators, to address fundamental problems in regenerative medicine.

Thesymposium also featured a talk byRobert Langer, David H. KochInstitute Professorin the department of chemical engineeringat the Massachusetts Institute of Technology. The most highly cited engineer in history, he spoke about lessons helearnedfromhisscientific and business successes and how he decidedto be his own champion after facing criticism for his novel ideas early in his career.

If you try to do things whether its convergence, or things that a lot of people disagree with you have tohang in there, Langer said.Having good intellectual property has been key toraising the funds to do these things, and medicine is an incredibly expensive thing.

And finally, you really need teams that are super driven, and I think these startup companies have been a wonderful way to do this.

The symposium was organized around four sessions: translation, inflammation, biomaterials andimmunoengineering.Invited speakers from across North AmericaincludedKim Warren(AVROBIO),Kenneth Walsh(University of Virginia),Sarah Heilshorn(Stanford University)andMegan Levings(University of British Columbia).

All speakers fromU of T and its partnerhospitals were lead investigators on Medicine by Designs multi-disciplinary, multi-institution team projects. They included:John Dick,Clinton RobbinsandShaf Keshavjee(University Health Network (UHN));Molly Shoichet(department of chemical engineering and applied chemistry and Institute of Biomedical Engineering);Juan CarlosZiga-Pflcker(Sunnybrook Health Sciences Centre);andAndras Nagy(Sinai Health System).

Ted Sargent, vice-president of research and innovation, and strategic initiatives,and a University Professor in the Edward S. Rogers Sr. department of electrical and computer engineering,opened the symposium by congratulatingMedicine by Design on its successful mid-term review, which was conducted in early 2020 by a panel of international experts and theCanada First Research Excellence Fund(CFREF), which funds Medicine by Design.

Medicine by Design has amplified existing areas ofexcellenceatU of Tandour partner hospitals (Toronto Academic Health Sciences Network),and pushed the boundaries of regenerative medicine to tackle cell-based therapies, strategies for endogenous repair and the use of a stem cell lens to target the triggers of disease,Sargent said. In fact, Medicine by Design is such a compelling collaborative, cross-disciplinary initiative that itis a template fora new class of initiatives at the University ofToronto theInstitutional Strategic Initiativesportfolio whosepurpose is to mobilize ambitious,groundbreaking, collaborative, multi-institutional research networks that tackleimportantresearch problems, buildmajorexternal partnershipsboth with industry and emerging companies as well as with global academic peers;and foster societal impact.

They support the pursuit of grand challenges and bold ideas across disciplinary boundaries,further elevate U of Ts profile in high priority research areas of strategic importance,and enable us to realize transformational impacts on issues of major societal import.

The symposium also offered an opportunity for almost 45trainees to present their research during a poster session.KerstinKaufmann, a post-doctoral fellow in the laboratory ofJohn Dick(Princess Margaret Cancer Centre,UHN), won first place.JonathanLabriola, apost-doctoral fellowinSachdev Sidhuslab(Donnelly Centre for Cellular and Biomolecular Research, U of T), placed second, whileSabihaHacibekiroglu, a post-doctoral fellow in the lab ofAndras Nagy(Lunenfeld-Tanenbaum Research Institute, UHN)placed third.The awards were sponsored by STEMCELL Technologies.

YasamanAghazadeh,a post-doctoral fellow in the labsofCristina Nostro(McEwen Stem Cell Institute, UHN)andSara Nunes Vasconcelos(Toronto General Hospital Research Institute,UHN),won theCCRMTranslation Awardfor the poster with the greatest translational potential.AndAi Tian, a post-doctoral fellow fromJulien Muffatslab (The Hospital for Sick Children), won thePeoples Choice Award, a new award this year that wasdetermined byvotingby symposium attendeesand sponsored byBlueRockTherapeutics.

Funded by a $114-million grant from CFREF, Medicine by Design brings together more than 145principal investigators at the University of Toronto and its affiliated hospitals to work at the convergence of engineering,medicineand science. It builds on decades of made-in-Canada excellence in regenerative medicine dating back to the discovery of stem cells in the early 1960s by Toronto researchers James Till andErnest McCulloch.

Regenerative medicine uses stem cells to replace diseased tissues and organs, creating therapies in which cells are the biological product. Regenerative medicine can also mean triggering stem cells that are already present in the human body to repair damaged tissues or to modulate immune responses. Increasingly, regenerative medicine researchers are using a stem cell lens to identify critical interactions or defects that prepare the ground for disease, paving the way for new approaches to preventing disease before it starts.

(Photo of Robert Langer by Jason Alden)

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Medicine by Design symposium highlights importance of convergence in regenerative medicine and human health - News@UofT

The research report on NK Cell Therapy and Stem Cell Therapy Market gives thorough insights regarding various key trends that shape the industry expansion with regards to regional perspective and competitive spectrum. Furthermore, the document mentions the challenges and potential restrains along with latent opportunities which may positively impact the market outlook in existing and untapped business spaces. Moreover, it presents the case studies, including the ones related to COVID-19 pandemic, to convey better understanding of the industry to all the interested parties.

The recent market trend of increasingly using NK Cell Therapy and Stem Cell Therapy for understanding the development of a disease extensively fuel the growth of this market in the coming years. Another trend that will aid the growth of the global NK Cell Therapy and Stem Cell Therapy market is the escalating demand for personalized medicine. Extensive investments are being made by various organizations, pharmaceutical companies, and governments for the research and development of drugs, and this is another trend that is benefiting the growth of the global NK Cell Therapy and Stem Cell Therapy market. This is because NK Cell Therapy and Stem Cell Therapy techniques enable researchers to compare NK Cell Therapy and Stem Cell Therapy changes between disease samples and normal samples. Public health can thus be analyzed as the changes in NK Cell Therapy and Stem Cell Therapy are influenced by internal biological system and environment directly.

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The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include: Osiris Therapeutics, Chiesi Pharmaceuticals, Molmed, Takeda Pharmaceutical, Medi-post, Chipscreen Biosciences, Affimed NV, JCR Pharmaceutical, Pharmicell, Innate Pharma SA, NuVasive, Anterogen, Altor BioScience Corporation.

NK Cell Therapy and Stem Cell Therapy Market Segmentation:

In market segmentation by types of NK Cell Therapy and Stem Cell Therapy, the report covers-

NK Cell TherapyStem Cell Therapy

In market segmentation by applications of the NK Cell Therapy and Stem Cell Therapy, the report covers the following uses-

Hospital & clinicsRegenerative medicine centersDiagnostic centersResearch institutesOthers

Regional Analysis for NK Cell Therapy and Stem Cell Therapy Market-:

1) North America- (United States, Canada)

2) Europe- (Germany, France, UK, Italy, Russia, Spain, Netherlands, Switzerland, Belgium)

3) Asia Pacific- (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Vietnam)

4) Middle East & Africa- (Turkey, Saudi Arabia, United Arab Emirates, South Africa, Israel, Egypt, Nigeria)

5) Latin America- (Brazil, Mexico, Argentina, Colombia, Chile, Peru)

The report provides insights on the following pointers :

Market Penetration: Comprehensive information on the product portfolios of the top players in the Supply Chain Analytics market.

Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market

Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market

Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies

Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Supply Chain Analytics market

NOTE: Our analysis involves the study of the market taking into consideration the impact of the COVID-19 pandemic. Please get in touch with us to get your hands on an exhaustive coverage of the impact of the current situation on the market. Our expert team of analysts will provide as per report customized to your requirement.

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Table of Content

Chapter 1 NK Cell Therapy and Stem Cell Therapy Introduction and Market Overview

Chapter 2 Executive Summary

Chapter 3 Industry Chain Analysis

Chapter 4 Global NK Cell Therapy and Stem Cell Therapy Market, by Type

Chapter 5 NK Cell Therapy and Stem Cell Therapy Market, by Application

Chapter 6 Global NK Cell Therapy and Stem Cell Therapy Market Analysis by Regions

Chapter 7 North America NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 8 Europe NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 9 Asia Pacific NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 10 Middle East and Africa NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 11 South America NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 12 Competitive Landscape

Chapter 13 Industry Outlook

Chapter 14 Global NK Cell Therapy and Stem Cell Therapy Market Forecast

Chapter 15 New Project Feasibility Analysis

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Global NK Cell Therapy and Stem Cell Therapy Market: Development, Current Analysis and Estimated Forecast to 2025 - The Courier

GALWAY, Ireland, & SAN DIEGO, Calif.--(BUSINESS WIRE)--ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has secured three new exclusive option license agreements which strengthen its off-the-shelf, dual-targeted natural killer (NK) cell therapy platform and extend its pre-clinical pipeline to four programs across both hematological and solid tumors.

The first option agreement, with Cellerant Therapeutics, gives exclusive rights to a humanized CLEC12A scFv binder. CLEC12A is strongly expressed by blasts in the majority of AML patients. The option to license has enabled ONK to expand its pre-clinical product portfolio, launching a fourth program (ONKT104). This dual-targeted approach combines the CLEC12A CAR with a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting death receptor 4 (DR4).

While expressed on leukemic stem cells, CLEC12A is absent from normal hematopoietic stem cells and we thus expect that our dual-targeted NK cell therapy approach should enable safe targeting, with a reduced risk of prolonged aplasia in AML, said Prof Michael ODwyer MD, ONK Therapeutics co-founder, and CSO.

The second agreement in-licenses a humanized, tumor-specific antibody targeting an aberrantly glycosylated tumor-associated form of MUC1 (TA-MUC1) from Glycotope GmbH. Multiple solid tumor types express the mucin MUC1, including non-small cell lung cancer, breast cancer, and ovarian cancer. This antibody will be integrated into ONKs pre-clinical program ONKT103, for solid tumors.

Non-selective targeting of MUC1 could be problematic since the target is also expressed by healthy tissues, but ODwyer explains how ONKs dual-targeted approach can be used to address this. We have designed a CAR tailored to the glycosylation pattern distinct to tumor-associated MUC1 with specific recognition of the carbohydrate antigens Tn and T on MUC1, the expression of which is restricted to cancer cells. Glycotope has identified the glycosylation pattern as a way to unlock the potential of TA-MUC1 as a solid tumor target. ONK is thus set to bring the natural benefits of NK cells over T cells to bear on TA-MUC1, in a tumor-specific fashion, while also further boosting efficacy and countering resistance through the use of our TRAIL variant targeting DR5, he said.

ONKs unique platform approach combines the expression of a chimeric antigen receptor (CAR) and a high affinity, membrane-bound TRAILv. The incorporation of these two humanized scFvs has the potential to minimize the risk of immunogenicity in the allogeneic setting.

ONK is also exploring several innovative strategies to improve the homing of NK cells. This is an important consideration as ex-vivo expansion can lead to changes in chemokine receptor expression. Through this new license agreement with the NIH, ONK plans to enforce the expression of CCR7, which is downregulated on NK cell expansion. This may improve the homing of NK cells to lymph nodes and is expected to be particularly useful for ONKs off-the-shelf CD19 program targeting B cell lymphoma, ONKT101, which is partnered with Avectas.

ONK is making rapid progress since it announced its most recent financing in October. Chris Nowers, ex Kite Pharma Head of Europe, who joined at that time as Chief Executive Officer, said: The recent American Society of Hematology meeting highlighted the NK cell therapy area as offering great hope as the next generation of advanced cell therapies. We believe our best-in-class off-the-shelf, dual-targeted NK cell therapy platform has the potential to improve performance and overcome some of the shortcomings seen with earlier approaches. These new licensing activities strengthen and expand our programs and illustrate our ambition and strategy to become a leader in this exciting field.

The company recently expanded its operations into the USA, moving into JLABS @ San Diego, Johnson & Johnson Innovations flagship facility, at the heart of San Diegos precision medicine and cell therapy cluster. This represents a second facility that complements its main R&D team and operations in Galway, Ireland. The companys recruitment drive across both facilities has been rapid and the company continues to expand its capability in key areas, including NK cell biology, construct design, gene editing, and process development.

-Ends-

ONK Therapeutics http://www.onktherapeutics.com ONK Therapeutics Ltd is an innovative cell therapy company dedicated to developing the next generation of off-the-shelf, dual-targeted NK cell therapies targeting solid and hematological cancers.

The company was founded in 2015, by Prof. ODwyer MD, of NUI Galway, an expert in translational multiple myeloma research, the tumor microenvironment, and exploitation of NK cells as cellular immunotherapy. Its core proprietary platform is based on a dual-targeted NK cell expressing both a chimeric antigen receptor (CAR) targeting a known tumor antigen and a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting the death receptor pathway (i.e. DR4 or DR5). This unique approach has the potential to enhance efficacy by addressing both intrinsic (e.g. CAR engagement of a tumor-specific antigen) and extrinsic (e.g. signaling through the death receptor pathway) apoptotic pathways and to reduce the susceptibility to possible target antigen escape through the engagement of tumor antigen-independent TRAILv.

Its pre-clinical pipeline comprises four programs;

In addition to the unique dual-targeted NK cell therapy platform, the company has a strong research focus on strategies to enhance homing and persistence, and overcome exhaustion, including the exploration of proprietary gene edits, such as the deletion of checkpoint inhibitory receptors in NK cells.

ONK Therapeutics is headquartered in the med-tech hub of Galway, Ireland, with a wholly-owned US subsidiary, ONK Therapeutics, Inc. based at JLabs @ San Diego. Shareholders include Acorn Bioventures, ALSHC (principally Seamus Mulligan), and Enterprise Ireland.

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About Avectas - http://www.avectas.com Avectas is a cell engineering technology business that has developed a unique delivery platform, Solupore to enable the ex vivo manufacture of cell therapy products, which have high in-vivo functionality.

Glycotope http://www.glycotope.com Glycotope is a biotechnology company utilizing a proprietary technology platform to develop highly tumor-specific monoclonal antibodies called GlycoBodies. GlycoBodies bind to targets (GlycoTargets) tumor-specific carbohydrate structure dependent, enabling the development of highly-specific immunotherapies across a broad range of cancer indications. Glycotope has to date discovered in excess of 150 GlycoTargets with GlycoBodies against eight of these targets currently under development.

Each GlycoBody can be developed in an array of modalities with different modes of action providing a unique offering in the (immuno) oncology space. Currently, six clinical and pre-clinical programs based on the GlycoBody technology are under development by Glycotope or its licensing partners.

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ONK Therapeutics Announces Three Exclusive Option License Agreements, Which Extend and Strengthen its Dual-Targeted NK Cell Therapy Pipeline -...

Cancer cells pose an uncanny ability to make new cells and dodge drugs, "somewhat like would-be robbers hacking the bank's alarm code," one doctor explains. But researchers at Cincinnati Children's Hospital Medical Center have figured out how cancer cells rewire themselves and, in turn, how to possibly overcome drug resistance.

This drug resistance may explain why some acute myeloid leukemia (AML) and other cancer patients suffer fatal relapses despite many improvements in leukemia outcomes over the years, according to a Children's news release.

"Overcoming resistance to therapy remains a holy grail of leukemia treatment," says Yi Zheng, Ph.D., director, experimental hematology and cancer biology at Cincinnati Children's. Zheng and his colleagues have now discovered a way to boost the effectiveness ofmTOR inhibitors, which prohibit unwanted cell proliferation.

"While the latest study is based on mouse models, building upon the findingspublished Dec. 21, 2020, in PNASeventually could improve outcomes for people with AML, and possibly other forms of cancer," a release says.

What Happens When Treatments Target mTOR?

"Using a novel mouse model, we have learned that deleting the mTOR gene prompts blood stem cells to multiply rapidly to open other pathways to continue producing new blood cells," says Zheng, the study's senior author. "We also found that leukemia cells use a similar response to continue multiplying despite mTOR-inhibiting treatments."

He says attacking mTOR essentially sets off alarms among hemopoietic stem cells (HSCs), which act like blood cell factories deep in bone marrow. Then the cells themselves produce a flood of new, re-wired blood cells. These re-wired stem cells, treated with mTOR inhibitors, can begin multiplying, rendering mTOR inhibitor drugs useless.

The co-authors say mTOR treatment resistance can be counteracted by inhibiting activity of the MNK, CDK9 or c-Myc genes. So-called BET inhibitors can act against c-Myc activity. Other inhibitors that are in clinical trials can act against CDK9.

Next Steps

Scientists at Cincinnati Childrens have already launched some of the research needed to prepare the combination therapies for in vivo test leading to human clinical trials, the news release says. That process will take time, but since mTOR inhibitors have been widely tested in clinical trials, investigators have a head start on exploring combination therapies.

Longer term, the findings may extend beyond AML, Zheng says, because mTOR has been a recognized target in most human cancers, including solid tumors like brain tumors.

Here is the original post:

New Combination Therapy Tested By Children's May Offer Hope For Leukemia Patients - WVXU

ASHLEY Cain has revealed more than 80,000 have people joined the stem cell register after he pleaded for the public's help to save his baby daughter's life.

Little Azaylia was diagnosed with one of the rarest forms of leukaemia, AML [Acute Myeloid Leukaemia] , last month and needs a stem cell transplant to beat the disease.

7

Ashley, 30, called upon his fans to help him and his partner Safiyya Vorajee find a donor - along with the charitable organisations DKMS and Anthony Nolan - for the four-month-old tot.

In a new interview, Ashley and Safiyya have spoken for the first time at their shock at the overwhelming amount of support they received and opened up about the turmoil they're going through as they watch their baby daughter fight for her life.

Former footballer Ashley said: "When Azaylia needed a donor the amount of people who came together straight away to order test kits, do the tests and then send them back, was crazy.

7

"The DKMS and Anthony Nolan probably get around 30,000 to 40,000 registers a year. We got 80,000 people in a single weekend.

"It's now topping 100,000. And not only are they helping Azaylia, they are helping the thousands of people who also need donors.

"Social media can be such a cruel and cynical place at times but this has made me realise how beautiful it can be and how beautiful the people using it can be.

"For that support we will be forever grateful."

Ashley and Safiyya are currently living in a hotel next to Birmingham Children's Hospital to ensure they can be with their daughter around the clock.

Because of Covid-19 restrictions the couple can not be with their baby daughter together so spend 24 hours a day with her on rotation so they can both spend equal amounts of time with her.

7

When they first discovered Azaylia was sick, Ashley said the couple were warned to expect the worst.

He explained: "When Azaylia first got diagnosed it looked really bleak.

"Me and you as normal people would have a white cell count of five. Someone with leukaemia, even an adult, would have a white cell count of 40.

"Azaylia had a white cell count of 200. Plus tumours in her lungs, kidneys and stomach.

"I am strong but having that news was something I never thought I would have to go through. It broke me. I was a broken man."

7

Azaylia has since undergone two rounds of chemotherapy and is responding well to treatment.

However she will need a life-saving transplant in order to beat the disease once and for all.

Ashley added: "Its very rare to have leukaemia in babys as young as Azaylia, she is the only baby on the ward.

7

"And she also has AML, the most aggressive type of leukaemia, which is even rarer.

"And what is even rarer again is the fact that she had tumours on her stomach, her lungs and her kidneys. And that her white blood cell count was so high.

"Realistically for her to have even got to this point is an absolute miracle."

Ashley and Safiyya also wanted to speak publicly to warn other parents about the signs to look out for after doctors repeatedly misdiagnosed Azaylia.

Ashley said: "We had back and forth to the doctors over the course of four weeks. She had cold type symptoms and we got told she had a blocked nose. At points we were pleading with the doctors to let us come in because we knew something wasnt right.

"Then we were told she had colic and then they told us she had constipation. We did all the things to treat that and then we noticed the mottling."

Going back to the beginning, Safiyya continued: There was an occasion four weeks after Azaylia was born when there was red spotting in her nappy.

7

I went to the doctors and they told me to keep an eye on it. Then a little while after she had a really bloated stomach. I called up the doctor and then I took them in for her first course of injections.

Prior to her having her six week injection the doctor gave her a once over. I told the doctor about her stomach and that her chest was really heavy, it sounded like her chest was rattling it was like she couldnt breathe properly.

Her eyes were gunking up too, to the point where they were really swollen. It was making her face then swollen.

The tummy was so hard, it was like a hard ball, obviously now that was all the tumours. They gave her laxatives to try and sort it out, they gave us colic mixture, they gave us a spray for her nose

To know a doctor has felt over all the symptoms that were there, and there were two-three-four-five doctors we saw. The doctor I sent the picture of the mottling to was an on call doctor and he was the one who said take her immediately to A and E.

7

The couple now credit Azaylia for giving them the strength to continue their appeal for donors.

Ashley added: We call Azaylia little lion, she has the face of an angel and the heart of a lion.

It is personally inspiring every day for us to see her sheer strength. Her waking up smiling every day, no matter what she is going through, gives us strength.

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We also have to thank Birmingham Childrens hospital. We heard a lot about them before and everything we had heard was right.

From the nurses to the cleaners to the doctors, everyone goes the extra mile. They do incredible work but they also make you feel so at home.

Its those little touches and the extra effort they put into helping you which they dont get paid for. They all go the extra mile. To everyone on ward 18, they are just incredible.

If you want to help, you can join the register here.

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Ashley Cain says over 80,000 people registered for stem cell donation in 48 hours after appeal to save baby - The Sun