Daily Archives: December 3, 2021

A new biotech startup with operations in Seattle and Durham, N.C., has launched with $40 million in new funding and a leadership team peppered with veterans of Seattle cell therapy biotechs.

Tune Therapeutics is deploying technology to fine-tune the activity of genes in cells. The company has developed a proprietary platform called TEMPO that operates as an epigenomic therapy, according to a statement. Epigenomics is a broad term typically applied to the machinery in cells that organizes how DNA is packaged, which affects gene activity.

Genetic diseases, cancers, and other conditions can result when gene activity is too high or low. TEMPO can locate epigenomic elements involved in disease, and it can tune the activity of genes or gene networks.

The company aims to take its tools from proof of concept in rare, single-gene disorders to common conditions that arent linked to a single gene mutation but are treatable through epigenomic control, said Charles Gersbach, acting chief scientific officer and biomedical engineering professor at Duke University, in a statement.

Gersbach co-founded the company with president and CFO Akira Matsuno and Fyodor Urnov, chair of the scientific advisory board. Urnov is a professor of genetics, genomics, and development at the University of California, Berkeley and previously led discovery and translational research at Sangamo Therapeutics.

Matsuno is formerly head of corporate development at Lyell Immunopharma, a gene and cell therapy company with a presence in Seattle that went public this year. He is also a former program lead at Seattles flagship cell therapy biotech, Juno Therapeutics, which was acquired by Celgene in a multibillion dollar deal in 2018.

Two other Juno veterans help round out the team, head of technical operations Heidi Zhang and head of research Blythe Sather. Sather also was previously senior director of T cell engineering at Lyell.

Tune is helmed by CEO and director Matt Kane, previously co-founder and CEO of gene and cell therapy company Precision BioSciences, which went public in 2019.

A company spokesperson told GeekWire that its TEMPO platform has two distinct modules. A targeting module binds to target DNA sequences, and effector module dials the activity of genes up or down by acting on epigenetic marks. These molecular marks are involved in packaging up DNA, for instance determining if it is tightly or loosely wound up, which affects gene activity.

By varying the target and effector modules in an iterative process, the platform can fine tune gene expression in diseased or exhausted cells.

Recent publications by Gersbachs research team have focused on advancing a commonly-used epigenome editing approach. This approach involves delivering a two-component protein to cells: one component (dCas9) binds to target DNA sequences, and a second modulates epigenetic marks.

In one recent study, Gersbachs group at Duke used this approach to activate a gene in stem cells in culture. His group has also delivered a similar system to the livers of mice to silence a gene involved in regulating cholesterol. Tune will maintain ongoing collaborations with Duke University to advance its platform.

The biotechs emergence builds on long running efforts by biotech and pharma to target the epigenome. Another epigenomics company, Chroma, also launched this November, with $125 million in funding. Tune currently has 35 employees and is advertising for positions in both Seattle and Durham.

Co-lead investors for the Series A round were New Enterprise Associates and Emerson Collective, with participation from Hatteras Venture Partners, Mission BioCapital, and others.

Editors note: This story has been updated with more details about Tunes platform.

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Tune Therapeutics launches with $40M in funding, aims to fine-tune activity of genes in cells - GeekWire

Star Trek creator Gene Roddenberrys signature on the shows first contract with Lucille Balls Desilu Productions is now an NFT. Roddenberry Entertainment is calling it the first Living Eco-NFT, which seems straight out of science fiction itself.

The NFTs creators implanted the signature, signed in 1965, into a living bacteria cell in the form of DNA code. As the cell duplicates, it creates new copies of the NFT over a billion in one night.

Even though there could quickly be billions of replicas, the NFT is called El Primero, which means the first in Spanish. Right now, though, the bacteria cells are dormant. Scientists working on the project freeze-dried the cells after 10 hours. They can be re-animated in the future, and then the zombie-bacteria can begin replicating themselves once again. In the meantime, the desiccated bacteria will be exhibited at the Art Basel Miami Beach art fair that kicks off on December 2nd. They fit inside a vial thats encased in a glass cube.

DNA is natures way of storing data. But instead of encoding that data as zeros and ones as computers do, the basic building blocks for DNA are the nucleotides adenine, thymine, cytosine, and guanine A, T, C, and G for short. Different combinations of those nucleotides are essentially genetic instructions for characteristics like hair and eye color. That code can also be used to store digital information like say, an NFT.

There are significant climate controversies swirling around NFTs and digital data more broadly. Data centers, where digital data is stored on hard disk drives, are notorious for guzzling up water and burning through electricity to keep servers cool. And NFTs tied to blockchains like Ethereum operate on an outstandingly energy inefficient security mechanism called Proof of Work. This method prompts miners to solve complex puzzles using energy-hungry machines to verify transactions and earn tokens, protecting the blockchains record of transactions by making it too expensive to mess with the ledger.

El Primero manages to avoid some of the climate drama of traditional data storage and NFTs. For starters, early research has shown that synthetic DNA can potentially save energy and avoid greenhouse gas emissions compared with current commercial data storage by storing way more data in a much smaller, denser package.

Second, the NFT wont be bought and sold on the most energy-hungry blockchains. Roddenberry Entertainment partnered with Solana Labs, whose blockchain operates on a mechanism called Proof of Stake that uses significantly less energy in comparison to the blockchain Ethereum of which most other NFTS are part. Proof of Stake nixes puzzles, instead requiring users to lock up some of their existing tokens as a security measure to prove they have a stake in keeping the ledger accurate. Getting rid of those puzzles drastically cuts energy usage and associated emissions.

A single transaction on Ethereum uses about as much electricity as the average US household over 6.81 days, by one estimate. Solana says a single transaction is equivalent to about two Google Searches. Minting one NFT on Solana uses about the same amount of energy as about eight Google searches, according to Solana head of communications Austin Federa.

Trevor Roth, COO of Roddenberry Entertainment, said in a statement that like Star Trek itself, the new NFT speaks to the world around us, acknowledging todays constant convergence of life and technology. For a franchise thats been imagining bizarre new uses of genetic engineering technology for more than thirty years, it feels appropriate.

Update November 30th 6:08PM: This story has been updated with more information about Solanas energy use and plans to exhibit the desiccated bacteria at Art Basel Miami Beach.

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Star Trek creators signature will live long and prosper in new NFT - The Verge

We've seen how 3D-printing can revolutionize certain manufacturing processes whether on Earth or anywhere else but there's a growing field of research looking at ways this can be applied to producing living, biological structures as well.

In a new study, scientists have outlined a new type of 'living ink' or bioink made from programmedEscherichia coli bacterial cells, which can be 3D-printed to create hydrogels in different kinds of shapes that release different types of drugs or absorb toxins, depending on how they're engineered.

What makes this approach different from previous bioinks is how it uses genetic programming to control the mechanical properties of the ink itself leading to better end results in the finished material and more practical uses for the ink (some existing bioinks don't operate properly at room temperature, for example).

Examples of the printed bioink. (Joshi et al., Nature Communications, 2021)

"A tree has cells embedded within it and it goes from a seed to a tree by assimilating resources from its surroundings in order to enact these structure-building programs," says chemical biologist Neel Joshifrom Northeastern University in Massachusetts.

"What we want to do is a similar thing, but where we provide those programs in the form of DNA that we write, and genetic engineering."

The way it works is by bioengineering the bacterial cells to create living nanofibers. The E. coli cells were combined with other substances to create the fibers, using a chemical process inspired by fibrin a protein that plays a key part in blood clots in mammals.

These protein-based nanofibers can then be fed into a 3D-printer and manipulated into various shapes. Unlike previous bioinks, this one doesn't use any artificial substances, and is instead entirely biological. It's squeezed out like a toothpaste, but can then keep its form if it is kept from drying out.

So far the technique has been used to make very small objects: a circle, a square, and a cone. But now that the scientists have shown that the microbial ink can be 3D-printed in this way, it opens up more possibilities for the future.

"If you were to take that whole cone and dunk it into some glucose solution, the cells would eat that glucose and they would make more of that fiber and grow the cone into something bigger," says Joshi.

"There is the option to leverage the fact that there are living cells there. But you can also just kill the cells and use it as an inert material."

In experiments, the team was able to combine their bioink with other microbes to perform specific tasks: absorbing toxic chemicals, for example, or delivering an anti-cancer drug. In the future, the ink could also be engineered to self-replicate, the researchers say.

This study builds on previous work by the same team, looking at how E. coli cells could be formed into a hydrogel that self-replicates when it comes into contact with a particular tissue opening up a new and sustainable method of manufacture that could be used on the Moon and Mars as well as here on Earth.

Although the 3D-printable bioink has only been used on a small scale so far, further down the line it could ultimately be used in everything from building self-healing structures to producing bottle caps that are able to remove dangerous chemicals from water.

"Biology is able to do similar things," says Joshi. "Think about the difference between hair, which is flexible, and horns on a deer or a rhino or something. They're made of similar materials, but they have very different functions.Biology has figured out how to tune those mechanical properties using a limited set of building blocks."

The research has been published in Nature Communications.

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This 3D-Printer Uses Ink Made From Microbes to Print Blobs That Are Alive - ScienceAlert

Preclinical modeling demonstrates potential for filler to enhance cell proliferation and new tissue regeneration for aesthetic medicine applications

REHOVOT, Israel, Dec. 2, 2021 /PRNewswire/ -- CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetic medicine company developing innovative technologies and products for tissue regeneration and organ manufacturing, today announced the publication of an article in the Plastic and Reconstructive Surgery journal titled "The Potential Use of Novel Plant-Derived Recombinant Human Collagen in Aesthetic Medicine." The article highlights favorable in-vitro and in-vivo results of CollPlant's photocurable dermal filler as well as other potential applications of this collagen technology in aesthetic medicine.

Schematic representation of the injection, sculpting, photocuring, and tissue regeneration phases in a photocurable dermal filler application

Following light illumination of the skin, CollPlant's photocurable dermal filler showed improved physical properties compared with standard of care, suggesting enhanced lifting effect and appearance. Biological properties assessed in a preclinical animal model, showed that the photocurable filler enhances cell proliferation and new tissue regeneration compared to standard of care.

"We are very pleased with these promising results of CollPlant's photocurable collagen technology, demonstrating its broad potential in aesthetic medicine applications", said Yehiel Tal, CollPlant's Chief Executive Officer. "Regenerative medicine aims to mimic nature, providing cells with growing environment as similar as possible to the original one. These published results further demonstrate recombinant human collagen's (rhCollagen) ability to serve as the ideal building block in regenerative medicine applications," Yehiel added.

CollPlant's photocurable dermal filler is composed of rhCollagen and hyaluronic acid and is intended for contour deficiencies corrections. The filler is designed to allow easy injection, followed by sculpting and in-situ hardening by light illumination of the skin.

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The Plastic and Reconstructive Surgery journal is the official medical journal of the American Society of Plastic Surgeons, the world's largest organization of board-certified plastic surgeons representing more than 7,000 Member Surgeons.

About CollPlant

CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. The Company's products are based on its recombinant human collagen produced with CollPlant's proprietary plant based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.

At the beginning of 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market. Later in 2021, CollPlant entered into a strategic co-development agreement with 3D Systems for a 3D bioprinted regenerative soft tissue matrix for use in breast reconstruction procedures in combination with an implant.

For more information, visit http://www.collplant.com.

Safe Harbor Statements

This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's history of significant losses, its ability to continue as a going concern, and its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the impact of the COVID-19 pandemic; the Company's expectations regarding the timing and cost of commencing clinical trials with respect to tissues and organs which are based on its rhCollagen based BioInk and products for medical aesthetics; the Company's ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based BioInk and medical aesthetics products including but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products in 3D Bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the Company's reliance on third parties to conduct some or all aspects of its product manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates; projected capital expenditures and liquidity; changes in the Company's strategy; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant is contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact at CollPlant:

Eran RotemDeputy CEO & Chief Financial OfficerTel: + 972-73-2325600/631Email: Eran@collplant.com

Cision

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CollPlant Announces Publication Highlighting its rhCollagen-based Photocurable Dermal Filler in the Plastic and Reconstructive Surgery Journal - Yahoo...

"Andreas and Jessie are both recognized industry leaders whose collective expertise perfectly complements that of our existing leadership team," said Emily Drabant Conley, Ph.D., chief executive officer at Federation Bio. "The clinical development and legal experience they bring will be of great value as we prepare to enter the clinic in the second half of 2022 with our lead program, FB-001, in enteric hyperoxaluria."

Dr. Grauer is a highly tenured physician scientist and pharmaceutical executive with more than 20 years of industry experience. He previously served as chief medical officer at Corcept Therapeutics, overseeing clinical development programs in endocrinology and oncology, as well as metabolic and neurologic indications. Prior to Corcept Therapeutics, Dr. Grauer served as vice president of global development at Amgen, leading clinical research efforts in bone, nephrology and inflammation. While at Amgen, he oversaw several large development programs spanning from early clinical research to FDA and international approvals and commercialization.

Dr. Grauer is an internist and endocrinologist by training. He received his medical education at the University of Heidelberg in Germany and at the Royal Postgraduate Medical School at the Hammersmith Hospital in London, UK, conducting subsequent clinical training at the University of Heidelberg. Dr. Grauer has authored more than 100 scientific publications and book chapters.

"Federation Bio's world-class science is fueling the development of an emerging treatment modality, engineered bacterial cell therapeutics, with thepotential treat a wide range of illnesses," said Dr. Grauer. "I'm honored to join the Federation Bio team and applymy extensive drug-development experience to bring this new therapeutic approachinto the clinic, with the aim of delivering therapies that provide meaningful, lasting benefits for serious illnesses."

Dr. Richardson joins Federation Bio from PACT Pharma, where she served as vice president of legal. Prior to PACT Pharma, Dr. Richardson served as senior counsel at Genentech, a member of the Roche group, where she managed legal functions around the company's worldwide oncology and immunology portfolios, from preclinical research through commercial products. Dr. Richardson began her career at the law firms of Morgan Lewis & Bockius LLP and Jones Day, after earning a Juris Doctorate at University of California, Davis, School of Law and a Doctor of Philosophy in Physiology/Biophysics from the University of California, Los Angeles.

About Federation BioFederation Bio is a biotechnology company pioneering a novel approach to create potent, durable and safe cell therapies. The company's first-in-class platform combines the power of genetic engineering and synthetic consortium design to control systemic immune responses and broad metabolic functions. Federation Bio's pipeline addresses a range of serious illnesses from metabolic disorders to metastatic cancer. The company's lead program is in enteric hyperoxaluria, a serious renal condition that affects more than 250,000 Americans and for which there are currently no approved therapies. Additional information can be found atwww.federation.bio

Media Contact:Michele ParisiForward Health Communications925-864-5028[emailprotected]

Federation Bio Inc.300 Utah Ave, Ste. 100South San Francisco, CA94080www.Federation.Bio

SOURCE Federation Bio

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Federation Bio Expands Leadership Team To Support Continued Advancement of Engineered Bacterial Cell Therapies - PRNewswire

Islamabad: Virtual University of Pakistan (VUP) organized the 1st International Conference on Bioinformatics and Computational Methods in Post Genomic Era at VU.

Prof. Dr. Bushra Mirza, Vice-Chancellor, Lahore College for Women University (LCWU), graced the event as Chief Guest. Mr. Naeem Tariq, Director Finance Virtual University of Pakistan attended the session as a special guest.

The conference was attended by eminent national and international scientists.

Keynote speakers included Prof. Dr. Erik Bongcam Rudloff, Head SLU-Global Bioinformatics Center, Dr. Shahid Mansoor (S.I) Chief Scientist, National Institute for Biotechnology and Genetic Engineering, NIBGE, Faisalabad, Dr. Senkevich Konstantin Montreal Neurological Institute and Hospital Department of Neurology & Neurosurgery, Department of Human Genetics, McGill University, Canada, Dr. Safee Ullah Chaudhary Syed Babar Ali School of Science and Engineering, LUMS Lahore, Dr. Nadeem A. Kizilbash, Head Department of Biochemistry Faculty of Applied Medical Science, Northern Border University, Saudi Arabia, Dr. Dong Ling TONG, Centre of IoT and Big Data, Faculty of I & C Technology, University Tunku Abdul Rahman, Malaysia, Prof. Dr. M. Kamran Azim Professor/Dean Faculty of Life Sciences, Mohammad Ali Jinnah University, Karachi, Prof. Dr. Mushtaq Hussain Principal Dow University College of Biotechnology Dow Health University Karachi, Dr. Ambrin Fatima Department of Biological and Biomedical Sciences, Aga Khan University Karachi, Dr. Misbah Irshad Department of Chemistry University of Education Township Campus Lahore, Ms. Anusha Amanullah and Ms. Iffat Waqar from Dow College of Biotechnology Dow University of Health Sciences Karachi, Dr. Waqasuddin Khan The Aga Khan University Karachi, Mr. Muhammad Farooq NIBGE, Faisalabad, Dr. Amjad Ali, NUST, Dr. Nusrat Jabeen The University of Karachi, Dr. Syed Mohammad Omer, Dow University of Health Sciences, Karachi, and Dr. Ammad Aslam Khan, Virtual University of Pakistan.

Dr. Bushra Mirza discussed the advancements in the techniques and tools of bioinformatics field. She said that these tools have made possible the high throughput analysis of genes and proteins. It has become an indispensable field in the post-genomic era. Apart from the analysis of genome sequence data, Bioinformatics is now being used for a vast array of other important tasks, including analysis of gene variation and expression, analysis and prediction of protein structure, she added.

The conference was comprised of four technical sessions, in these sessions the eminent speakers shed light on how bioinformatics is helping in the development of vaccines against COVID-19; they also summarized the evolution of bioinformatics and its use in the field of life sciences.

Mr. Naeem Tariq said that such summits provide an opportunity to renew contacts and discuss the expanding role of bioinformatics and computing methods in the domains of genetics, genomics, and transcriptomics. He congratulated conference chair, Dr. Muhammad Tariq Pervez, HoD Bioinformatics and Computational Biology, Mr. Mirza Jawad ul Hasnain, Lecturer Department of Bioinformatics and Computational Biology for organizing a successful international event.

The chief guest of the closing ceremony, Prof. Dr. Shahida Hasnain (Ex-Vice Chancellor, Lahore College for Women University, Multan) addressed the audience and highlighted the research area of Bioinformatics and Computational Biology. She encouraged researchers to use these approaches in a way that will help them to discover a study that will be the need of the hour.

At the end of the conference shield and Certificate were distributed among the keynote speakers and participants.

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VU holds 1st International Conference on Bioinformatics and Computational Methods in Post Genomic Era | The Academia - The Academia Mag

A Type 1 diabetes patient is the first patient to be cured of the disease with a new treatment, a clinical trial report claims, paving the way for those who also hope to beat it.

Per The New York Times, the clinical trial by Vertex Pharmaceuticals has been testing a treatment for decades. Thirty years and $50 million later, the first patient is cured.

Brian Shelton, now 64, got his first cell infusion of stem cells, which act like insulin-producing pancreas cells that his body lacked.

His body now controls its insulin and blood sugar levels automatically. Its a whole new life, Shelton said in The New York Times report. Its like a miracle.

It is a remarkable result, Dr. Peter Butler, a diabetes expert at the University of California, Los Angeles, said in the report. To be able to reverse diabetes by giving them back the cells they are missing is comparable to the miracle when insulin was first available 100 years ago.

The study will continue for five years, involving 17 people with a severe case of Type 1 diabetes. This will give 9 million people who are suffering from this disease a chance at a major change in their life.

According to the Centers for Disease Control and Prevention, for Type 1 diabetes, the pancreas doesnt make enough insulin. Without insulin, blood sugar can build up in the bloodstream, instead of entering cells to be used for energy.

Currently, the cell infusion treatment requires cells that are within a class of immunosuppressants that depress the immune system, said professor Douglas Melton, whose lab pioneered the science behind the therapy, per The Harvard Gazette

Without the immunosuppressants, these cells would be rejected by the body. We want to find a way to make cells by genetic engineering that are not recognized as foreign, he said.

Dr. Scott Summers, chairman of Nutrition and Integrative Physiology at the University of Utah. thinks a lot of work is left to be done and he views this study with caution.

At this point, we have only read about the results in one patient. The clinical trial is still ongoing, and the full set of results arent anticipated for several years. The paper hasnt been peer-reviewed. A heated discussion is actually ongoing amongst scientists about whether it is ethical or appropriate to publicize data so early in the study, he told the Deseret News.

The fact that it is a biotechnology company permits a marketing aspect that cannot be ignored. Its odd for a press release to occur so early in the study, he added.

Summers also has some suspicion regarding Melton. Despite being an excellent scientist, he reacted to a huge paper five years ago. His group allegedly discovered a hormone that could stimulate the proliferation of insulin cells. But those findings could not be replicated.

So, Melton did what any ethical scientist would do he retracted the paper.

This is a good reminder that findings need to be rigorously evaluated and replicated by multiple groups before carving them in stone, said Summers.

Despite these concerns, Im excited, he added. This discovery could have a transformative impact on our understanding and treatment of this insidious disease.

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New testing finds that one man might be the first cured of Type 1 diabetes. Whats next for the research? - Deseret News

Although the scholarship and literature dates the ideology of eugenics back to Plato, the contemporary manifestation of its practice is still very evident from the various selective-abortion laws. Taking its cue from the modern theories such as the Malthusian theory, Social Darwinism and Mendelian genetics, phenomena of human-selection and human-perfection has been the core aim of medical sciences as well as the state.

Eugenics, as a social movement and ideology that aims to perfect the human stock continues to view disability as a matter of grave societal concern which can only be tackled by its breeding-out. Therefore, while sterilization, abortion and mass killing were products of eugenics during the World War II, prenatal testing and selective-abortion is argued to be its extension in todays time. Under the garb of womens rights, public health and greater societal good, prenatal testing and selective abortions truly represent a significant step towards the ultimate achievement of the eugenicists dream of eliminating disabilities by eliminating disabled people. Contrary to the scholars who believe in the retreat of eugenics post the War, it is argued that the principles of eugenics has now secured a hidden niche for itself and its proponents in the institution of law.

Under the garb of womens rights, public health and greater societal good, prenatal testing and selective abortions truly represent a significant step towards the ultimate achievement of the eugenicists dream of eliminating disabilities by eliminating disabled people.

It has been rightly argued by Smitha Nizar in her book, The Contradiction in Disability Law, that the most powerful vehicle of the eugenic ideology has been the law. From the very onset of the abortion reform movement, disability-based selective abortion enjoyed significant public support. Serving the paternalistic interests of the state, law was first employed as a facilitator of eugenics to curb the outbreak of Rubella virus and foetal defects back in 1960s in the U.S.A.

Also read: The Bias Against Disability Rights In The Abortion Laws Discourse

Similarly, Indian laws employed and sanctioned disability-based selective abortions as a method to thwart the growing population with disabilities and thereby lighten the burden of the states obligation to the disabled community. Prima facie, the issue of selective abortions does not seem to pertain particularly to the disabled community, however, there is more than what meets the eye. It is argued that selective-abortions under Section 4 of the PDNT Act as well as Section 3 of the MTP Act does more than just comply by the medical model of disability and serve the eugenic interests of the state. Evidently, it aids in erasing the disabled community by not even letting them being born. It also bares the entire spectrum of human traits for being assessed and analysed on the basis of their individual vitality. Whether its sex, physical strength or overall health, if the regime of selective abortions continue, it is argued that it will open a Pandoras box of trait selection.

The social purpose of prenatal tests is to reduce the incidence of live births of people with disabilities.

Eugenic abortion laws unmask the exponential harm legislations such as the MTP do in the society. Concurring to what Lisa Blumberg opines, it is contended that while the reason for prenatal tests has been to only detect abnormalities, the social purpose of it is to reduce the number of disability-laden births which further leads to denigration of all vulnerable as well as disabled people before and after birth.

By diminishing the value as well as visibility of disability from the society, the state through the laws of selective abortion inherently disenfranchises the community from the abled demography to paint a perfectly healthy picture of human society which devoid of any forms of abnormalities. It is claimed that by the pushing of disabled community to the very end of the society, the state attempts to disregard their pressing concerns. As rightly asserted by Smitha Nizar, it is easier for the state to prevent the birth of a disabled person through laws, then to actually commit to their cause and respond to their concerns. By the manner of preventing their births, state tries to washes off its hands from any kind of obligation, social services and protection people with disability might advocate and demand for.

However, ironically, the states attempt to prevent disability through selective abortion is nothing but a fools errand. By discounting the possibility of instances of post-birth disability, the purpose of selective-abortion also is lampooned to a great extent. It is thus advanced that the state cannot possibly erase the disabled community. Instead of attempting to absolve itself from legal, moral and ethical obligations and duties through selective-abortion laws, it should rather address and respond to the concerns of the community in an affirmative manner.

Also read: The Ableist Ruling Indian Government: Eugenics & Disability As Suffering

... And as science evolves, we need to ask: should prenatal testing include autism, breast cancer risk genes, or even ones sexual orientation?

Being plagued by the powerful forces of Brahmanical patriarchy and its function of female foeticide, Indian culture has always accepted and practiced selective-abortions in some form or the other. Similar to the perception of disability, the social identity of female was considered undesirable and devalued. The very purpose of enacting a law such as the PDNT Act was to regulate the use of prenatal technologies and prevent the instances of female foeticide which is a type of selective-abortion based on the trait of sex.

It is argued that selective abortion opens a Pandoras box as selection and preference of one trait implies the legitimisation and validation of the other traits as well. Thus, the real question is where does human selection and perfecting end?

While on one hand, the act outlawed prenatal sex determination, on the other hand, it articulated the undesirability of and the consequent discrimination against people with disabilities. It is argued that selective abortion opens a Pandoras box as selection and preference of one trait implies the legitimisation and validation of the other traits as well. Thus, the real question is where does human selection and perfecting end?

With the rapidity of advancement in the respective fields of bioethics, genetic engineering and technology, it is not too far-fetched to forecast a future society with a uniform human mould. If not uniform, it is argued that selective-abortions wipe out not just the disabled communities, but also any other such trait that falls outside the societal mould.

Whether it is a disease like cancer or certain personal aspect such as ones sexual orientation, the reigns of human society shall be in the hands of medicine and those who practice medicine. In addition to the power of medical discourse which is as claimed by Anita Ghai, quite universal, it is argued that the state and its paternalistic interests will play a predominant role in defining the human body and its traits.

As witnessed from the case of female foeticide in India, the initiative of banning sex-based abortions was primarily to cater to the two-fold interests of the state, namely, the skewed sex-ration and social reproduction. Consequently, this interplay of the institution of medical science and medical professionals and the state illustrates a distant, yet plausible emergence of the eugenics.

Samuel R Bagenstos, Disability and Reproductive Justice(2020) 14 Harv L & Poly Rev 273.

Mary Ziegler, The Disability Politics of Abortion (2017) Utlah Law Review 587.

Lisa Blumberg, The Politics of Prenatal Testing and Selective Abortions 12 1994 Sexuality and Disability 153.

Carolyn Y. Johnson, DNA Blood Test can detect Prenatal Problems The Boston Globe < https://www.bostonglobe.com/lifestyle/health-wellness/2014/02/26/new-study-suggests-prenatal-genetic-tests-could-offered-all-pregnant-women/V1GQuRL4jkr1M6Oe1XcQCK/story.html> accessed on 13th January 2021.

Kavana Ramaswamy, Addressing Abortion: Lessons from the Problems of Female Feticides in India (2017) 27 Transnational Law and Contemporary Problems 1.

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The Interplay Of Eugenics And Disability Bias In Selective-Abortion Laws - Feminism in India

Topline data show SAB-176 achieved statistically significant reductions in viral load and clinical symptoms and it appeared safe and well-tolerated

Second clinical proof of concept achieved by DiversitAbplatform in past two months

Positive clinical results confirm that SABs fully-human polyclonal antibodies can be broadly neutralizing to both known and unknown viral variantsa valuable feature when addressing rapidly mutating pathogens

SAB plans to further evaluate SAB-176 in a Phase 2 influenza clinical trial slated to beginin 2Q 2022

SIOUX FALLS, S.D., Dec. 01, 2021 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced that SAB-176, its investigational therapeutic for the treatment of seasonal influenza, achieved statistically significant (p = 0.026) reductions in viral load and clinical signs and symptoms compared to placebo in a Phase 2a challenge study. In the study, SAB-176 appeared to be safe and well-tolerated. SAB-176 is a quadrivalent fully human polyclonal antibody therapeutic candidate designed for the treatment of moderate to severe Type A and B seasonal influenza viruses.

We are highly encouraged by these topline results showing that treatment with SAB-176 achieved statistical significance in reducing influenza viral load and clinical signs and symptoms in treated subjects, despite the small size of this first Phase 2 study. These data suggest that SAB-176 has the potential to be an effective treatment for this prevalent, highly-mutating virus that resurfaces annually and is a major source of hospitalizations and deaths, said Tom Luke, MD, Chief Medical Officer of SAB Biotherapeutics. These trial results support advancing SAB-176 as a potential treatment for seasonal influenza through further clinical studies, and we look forward to sharing additional data as it becomes available.

These positive efficacy data for SAB-176 represent the second clinical proof of concept achieved by our DiversitAbplatform in the past two months, said Eddie J. Sullivan, PhD, Co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics. In September our investigational COVID-19 therapy SAB-185 met the pre-defined efficacy goal for advancement from Phase 2 to Phase 3 in the NIH-sponsored ACTIV-2 trial. These back-to-back clinical successes for our first two pipeline products give us confidence that the DiversitAb platform is clinically validated. They reinforce our commitment to advancing this unique platform, with its demonstrated ability to rapidly generate therapeutic candidates for highly mutating pathogen targets with ongoing resurgence and pandemic potential, including influenza and COVID-19.

About SAB-176 Challenge StudyThe Phase 2a challenge study, initiated in June 2021, was a randomized, double-blind, placebo-controlled study evaluating the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza virus strain (pH1N1). Participants were randomized to receive either SAB-176 (25 mg/kg dose) or placebo and were intranasally inoculated with pandemic H1N1 (2009/California) virus, and nasopharyngeal swabs were taken 8 days after inoculation.

The primary endpoint of the study was reduction of the nasopharyngeal viral load of subjects treated with SAB-176 (expressed as area under the curve, or AUC) compared to those receiving placebo over an 8-day timepoint as measured by qRT-PCR. SAB-176 met the primary endpoint of significantly reducing patient pH1N1 influenza viral load in the treated subjects (p = 0.026, one sided).

A secondary endpoint of the challenge study was reduction of clinical flu signs and symptoms in the subjects receiving active treatment (n=8) compared to placebo controls (n=12) for those who had signs and symptoms. SAB-176 achieved statistical significance in meeting the secondary endpoint at Day 4 (p = 0.013, one sided) in symptomatic patients. Additional analyses of secondary endpoint data are underway.

In this study SAB-176 also appeared to be safe and well tolerated. No SAB-176-related serious adverse events (SAEs) were observed, and most adverse events were mild to moderate. Based on these positive efficacy and safety results, SAB plans to further evaluate SAB-176 in advanced clinical trials.

One remarkable aspect of these results is that SABs Tc Bovine were not immunized to the specific influenza virus strain that was used in the challenge study, added Christoph Bausch, PhD, Chief Scientific Officer of SAB Biotherapeutics. Nonetheless, the statistically significant reduction in virus load and symptoms that were achieved confirm that SAB-176 demonstrated high cross reactivity to this pandemic strain. This reinforces a unique and timely feature of our DiversitAbplatformthe diversity of the human antibodies it produces gives our therapeutics the potential to be broadly neutralizing to both known and unknown viral variantsa very valuable feature when addressing rapidly mutating pathogens.

For more information on the Phase 2a clinical trial, visit clinicaltrials.gov (Identifier NCT04850898).

About SAB-176SAB-176 is a multivalent, broadly neutralizing fully-human polyclonal antibody therapeutic candidate in development for the treatment or prevention of severe influenza. The novel, specifically-targeted therapeutic leverages the natural human biological immune response to specifically bind to Type A and Type B influenza viruses. Like vaccines, it can be modified to address annual strain changes, when needed, to maintain broader coverage as the flu virus mutates. Preclinical data suggests that SAB-176 offers broad protection against diverse influenza strains.

SABs novel DiversitAb immunotherapy platform enables the production of large amounts of targeted, highly potent human polyclonal antibodies. The platform leverages transchromosomic cattle (Tc Bovine) that have been genetically designed to generate fully human antibodies (immunoglobulin G) rather than bovine antibodies, in response to inoculation with an immunogen.

To develop and produce SAB-176, Tc Bovine were hyperimmunized with a quadrivalent antigen, including a number of influenza strains. Within a brief period of time, the Tc Bovine generated significant amounts of fully-human antibodies to combat the virus, driving titers beyond the levels known to be protective. Plasma was collected (in a similar manner as from human plasma donors), then purified to isolate the antibodies that comprise the therapeutic treatment.

About Seasonal InfluenzaInfluenza virus infection is one of the most common infectious diseases and can lead to severe illness, and death. According to the US Centers for Disease Control (CDC), on average about 8% of the US population gets sick each flu season and between 12,000 and 61,000 infected Americans die, depending on the severity of the flu season. In 2019-2020, considered a moderate flu season, 38 million people in the US became ill with the flu, 18 million saw a healthcare provider for treatment, 400,000 were hospitalized and an estimated 22,000 died. Globally, there are between 2.5 and 5 million influenza-related hospitalizations per year. The CDC recommends an annual flu shot for almost everyone over the age of six months, but each year less than half the population is vaccinated. In addition, because influenza viruses are highly mutating, the vaccines have varying levels of protection in any year, but rarely exceed 50% protection. Young children, the elderly, immune-compromised individuals, and patients with chronic health conditions are especially at risk of poor outcomes from influenza, yet there are few approved therapies for the treatment of influenza.

About SAB Biotherapeutics, Inc.SAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. SAB has applied advanced genetic engineering and antibody science to develop transchromosomic (Tc) Bovine that produce fully-human antibodies targeted at specific diseases, including infectious diseases such as COVID-19 and influenza, immune system disorders including type 1 diabetes and organ transplantation, and cancer. SABs versatile DiversitAb platform is applicable to a wide range of serious unmet needs in human diseases. It produces natural, specifically targeted, high-potency, human polyclonal immunotherapies. SAB is currently advancing multiple clinical programs. For more information on SAB, visit: https://www.sabbiotherapeutics.com/ and follow @SABBantibody on Twitter.

Contacts:Melissa Ullerich+1 605-679-4609mullerich@sabbiotherapeutics.com

Courtney Turiano (investors)Stern IR+1 212-698-8687Courtney.Turiano@sternir.com

Forward-Looking Statements Certain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as believe, may, will, estimate, continue, anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events. These statements are based on the current expectations of SAB and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict, will differ from assumption and are beyond the control of SAB. Forward-looking statements are subject to various risks and uncertainties, including, among others, those related to the COVID-19 pandemic; SABs ability achieve successful results for its product candidates, the availability of financing, and trends affecting SABs financial condition or results of operations. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are described under the sections entitled "Risk Factors" in the Company's proxy statement/prospectus filed with the Securities and Exchange Commission (the "SEC") on September 24, 2021. Such factors may be updated from time to time in SABs periodic filings with the SEC, which are accessible on the SECs website at http://www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. The forward-looking statements speak only as of the date of this press release, and SAB expressly disclaims any obligation or undertaking to publicly update or review any forward-looking statement.

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SAB Biotherapeutics Announces SAB-176 Met its Primary Endpoint in Phase 2a Challenge Study in Adults Infected with Influenza Virus - BioSpace

There is much media hype around the fourth industrial revolution (4IR) and what it will hail for social and economic development. It is defined as a fusion of advances in artificial intelligence (AI), robotics, the internet of things (IOT), genetic engineering, quantum computing, and more.

One thing is clear: the world is not on the brink of a technological revolution that will fundamentally alter the way we live, work and relate to one another but rather we are in the thick of it.

This is borne out by research, with one Statista study forecasting the number of IOT devices worldwide will triple from 8.74 billion in 2020, to more than 25.4 billion IOT devices by 2030. The same study noted that in 2020, the highest number of IOT devices was in China, at 3.17 billion devices.

IOT devices are used in all types of industry verticals and consumer markets, with the consumer segment accounting for around 60% of all IOT connected devices in 2020. This share is projected to stay at this level over the next 10 years.

The most important use cases for IOT devices in the consumer segment are internet and media devices such as smartphones, where the number of IOT devices is forecast to grow to more than eight billion by 2030. Other use cases with more than one billion IOT devices by 2030 are connected (autonomous) vehicles, IT infrastructure, asset tracking plus monitoring and smart grid applications.

Unpacking 4IR, IOT and technology spending

The first industrial revolution used water and steam power to mechanise production, while the second used electric power to create mass production, and the third utilised electronics and information technology to automate production.

Now the 4IR has taken the innovations of the third and built on them to create the digital revolution that has been occurring since the middle of the last century. It is said to be characterised by a fusion of technologies that is blurring the lines between the physical, digital and biological spheres.

Today's transformations represent not merely a prolongation of the third industrial revolution, but rather the arrival of a fourth and distinct one.

The speed of current breakthroughs has no historical precedent, as when compared with previous industrial revolutions, the fourth is evolving at an exponential pace.

The speed of current breakthroughs has no historical precedent, as when compared with previous industrial revolutions, the fourth is evolving at an exponential pace. Moreover, it is disrupting almost every industry in every country, with the breadth and depth of these changes heralding the transformation of entire systems of production, management and governance.

So, what exactly is the 4IR? According to the World Economic Forum (WEF), it is a new era that builds and extends the impact of digitisation in new and unanticipated ways. In other words, it is the convergence of technology, digital, data and artificial intelligence that brings about new and unanticipated ways of working, living and engaging, such as in a metaverse.

It can also be said to be about the internet of everything from fitness trackers to the smart thermostats used both commercially and in homes, to the fleet-management solutions that tell us when our packages will arrive IOT is now embedded in the lives of consumers, as well as the operations of enterprises and governments.

IOT is the holy grail of innovation in the 21st Century, as predicted by everyone from McKinsey to Gartner. It largely started with the invention of the cloud and has since accelerated with the advances in both communication technology as well as new engineering innovation of IOT devices.

In a world where many companies suffer revenue declines, it is clear that IT spending is accelerating ahead of revenue expectations. According to Gartner, technology spending has entered a new build budget phase, with worldwide IT spending projected to total $4.2 trillion by the end of 2021, which represents an increase of 8.6% over 2020.

The research team goes on to note that CIOs are looking for partners that can think past the digital sprints of 2020 and be more intentional in their digital transformation efforts in 2021.

Boards and CEOs are much more willing to invest in technology that has a clear tie to business outcomes, and less so for everything else. For example, the IT services segment is among the top three highest growth areas for 2021, primarily due to a boost in infrastructure-as-a-service spending that supports mission-critical workloads and avoids high on-premises costs. The IT services segment is forecast to total $1.2 trillion in 2021, an increase of 9.8% over 2020.

However, IOT is not a panacea for all business ills according to McKinsey, IOT has faced headwinds related to change management, cost, talent and cyber security, particularly in enterprises.

With this level of investment there are unquestionably opportunities for South African businesses capable of identifying and capitalising on them. IOT start-ups need to focus on finding the right strategic partnerships that are based on mutually acceptable values of trust and respect.

In my next article, I will expand on the state of SA's readiness for the 4IR.

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In the thick of the opportunity revolution - ITWeb