Regeneron, Pfizer and BioNTech Accused of Infringing Allele Patent in Connection with COVID-19 Technologies – IPWatchdog.com

Only through use of mNeonGreen were [Pfizer and BioNTech] able to develop and test the BNT162 vaccine candidate at lightspeed, making them first to market [and] earning them an immediate $400 million in grants and over $4 billion in sales of the vaccine to- date. Allele Complaint

Allele Biotechnology and Pharmaceuticals, Inc. (Allele) has accused Regeneron Pharmaceuticals, Inc. (Regeneron); Pfizer, Inc. (Pfizer); and BioNTech SE and BioNTech US, Inc. (collectively BioNTech) for allegedly infringing U.S. Patent No. 10,221,221 (the 221 patent), which is directed to an artificial flourescent, i.e. mNeonGreen, used for testing COVID-19 assays against vaccine candidates. Allele argues that Regeneron, Pfizer and BioNTech have been infringing the 221 patent by taking mNeonGreen for their own unauthorized commercial testing and development.

Regeneron has been in the news lately for famously providing the antibody cocktail given to President Donald Trump shortly after he tested positive for COVID-19 last week. The cocktail is name in the complaint as one of the allegedly infringing technologies.

The 221 patent, titled Monomeric Yellow-Green Fluorescent Protein from Cephalochordate, was assigned to Allele and directed to high performance monomeric yellow-green fluorescent proteins. Although mNeonGreen was Alleles breakthrough in fluorescent protein technology, Allele has many other achievements, including advances in RNA interference, Fluorescent Proteins, Induced Pluripotent Stem Cells (iPSCs), Genome Editing, and camelid derived Single Domain Antibodies. Most recently, Allele has also been actively engaged in combating COVID-19, initiating impactful diagnostic and therapeutic platforms premised on speed, accuracy, and sensitivity. Alleles mNeonGreen technology has been licensed to hundreds of organizations and universities. As asserted by Allele, mNeonGreen facilitates quick, targeted, and precise receptor research, including for potential therapeutics to treat COVID-19.

Allele filed a Complaint against Regeneron in the U.S. District Court for the Southern District of New York alleging that Regeneron has been using Alleles patented mNeonGreen technology. Allele cited multiple published articles and papers written by Regeneron representatives. The Complaint noted that Regeneron did not have a license to use Alleles mNeonGreen technology, despite Alleles consistent showing that it is willing to license its mNeonGreen technology on reasonable terms in order to help facilitate the use of that protein by third parties in their efforts to develop new and essential technologies. Also, according to the Complaint, Allele sought to discuss licensing arrangements with Regeneron after learning of the infringement of the 221 patent, but Regeneron ignored Alleles attempts.

The Complaint asserted that Regeneron directly infringed the mNeonGreen technology claimed in the 221 patent and, by way of its publications, press releases, and other papers, caused others to directly infringe the mNeonGreen technology claimed in the 221 patent. Thus, Allele asked the court, in part, for: (1) a finding that the 221 patent is valid and enforceable, (2) a judgment that Regeneron had infringed, actively induced infringement of, and/or contributed to the infringement of one or more claims of the 221 patent, (3) a judgment that Regenerons infringement was willful, and (4) an award of damages or other monetary relief to adequately compensate Allele for Regenerons infringement of the 221 patent, and such damages be trebled under 35 U.S.C. 284 and awarded to Allele, with pre-judgment and post-judgment interest as allowed by law.

The Complaint against Pfizer and BioNTech (collectively, Defendants) was filed in the U.S. District Court for the Southern District of California and alleges that the Defendants infringed Alleles 221 patent using mNeonGreen throughout their COVID-19 vaccine trials. Pfizer was engaged with BioNTech in the development of their BNT162 MRNA-based vaccine candidate. Allele asserted that [o]nly through use of mNeonGreen were Defendants able to develop and test the BNT162 vaccine candidate at lightspeed making them first to market, earning them an immediate $400 million in grants and over $4 billion in sales of the vaccine to- date [which]was simply the downstream benefit that Defendants enjoyed (and presumably the world will enjoy from the vaccine) from their choice to use Alleles mNeonGreen.

According to the Complaint, BioNTech adopted Alleles mNeonGreen technology in its COVID-19 vaccine trial and literally infringed claims 1, 2, 4 and 5 of the 221 patent. Allele asserted that it has not granted the Defendants authorization, license, or permission to practice the inventions claimed in the 221 Patent. Allele also asserted that Defendants infringement was willful because the defendants had actual knowledge of the 221 Patent and the obvious risk of infringement by continued use of mNeonGreen throughout their development of their COVID-19 vaccine candidate in the United States. Thus, Allele requested, in part, that the court (1) find that the 221 Patent has been infringed by the Defendants in violation of 35 U.S.C. 271, (2) find that the Defendants infringement of the 221 Patent was been willful, (3) award adequate damages to compensate Allele for the Defendants infringement, and (4) an award of treble damages for the period of any willful infringement by the Defendants pursuant to 35 U.S.C. 284.

Image Source: Deposit Photos Author: Rewat Image ID: 358544690

Rebecca Tapscott is an intellectual property attorney who has joined IPWatchdog as our Staff Writer. She received her Bachelor of Science degree in chemistry from the University of Central Florida and received her Juris Doctorate in 2002 from the George Mason School of Law in Arlington, VA.

Prior to joining IPWatchdog, Rebecca has worked as a senior associate attorney for the Bilicki Law Firm and Diederiks & Whitelaw, PLC. Her practice has involved intellectual property litigation, the preparation and prosecution of patent applications in the chemical, mechanical arts, and electrical arts, strategic alliance and development agreements, and trademark prosecution and opposition matters. In addition, she is admitted to the Virginia State Bar and is a registered patent attorney with the United States Patent and Trademark Office. She is also a member of the American Bar Association and the American Intellectual Property Law Association.

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Regeneron, Pfizer and BioNTech Accused of Infringing Allele Patent in Connection with COVID-19 Technologies - IPWatchdog.com

Dolly the Sheep: ’90s Media Sensation – Mental Floss

It was Saturday, February 22, 1997, and Scottish researchers Ian Wilmut and Keith Campbell were expecting a final moment of calm before the results of their unprecedented scientific experiment were announced to the world.

The team had kept the breakthrough under wraps for seven months while they waited for their paper to be published in the prestigious journal Nature. Confidential press releases had gone out to journalists with the strict instruction not to leak the news before February 27.

But that night, the team was tipped off that journalist Robin McKie was going to break the story the very next day in the British newspaper The Observer.

Wilmut and Campbell raced to the lab at the Roslin Institute on Sunday morning as McKie's story hit the media like a thunderbolt. International news outlets had already started swarming at the institute for access to Wilmut and Campbell's creation: Dolly the sheep, the world's first mammal successfully cloned from a single adult cell. Shielded from the general public, she stuck her nose through the fence and munched calmly on the hay in her pen, unperturbed by the horde of news photographers. Dolly, a woolly, bleating scientific miracle, looked much like other sheep, but with a remarkable genetic difference.

By the end of that Sunday, February 23, nearly every major newspaper in the world carried headlines about Dolly the sheep.

Born on July 5, 1996, Dolly was cloned by Wilmut and Campbell's team at the Roslin Institute, a part of the University of Edinburgh, and Scottish biotechnology company PPL Therapeutics. The scientists cloned Dolly by inserting DNA from a single sheep mammary gland cell into an egg of another sheep, and then implanting it into a surrogate mother sheep. Dolly thus had three mothersone that provided the DNA from the cell, the second that provided the egg, and the third that carried the cloned embryo to term. Technically, though, Dolly was an exact genetic replica of only the sheep from which the cell was taken.

Following the announcement, the Roslin Institute received 3000 phone calls from around the world. Dolly's birth was heralded as one of the most important scientific advances of the decade.

But Dolly wasn't science's first attempt at cloning. Researchers had been exploring the intricacies of cloning for almost a century. In 1902, German embryologists Hans Spemann and Hilda Mangold, his student, successfully grew two salamanders from a single embryo split with a noose made up of a strand of hair. Since then, cloning experiments continued to become more sophisticated and nuanced. Several laboratory animal clones, including frogs and cows, were created before Dolly. But all of them had been cloned from embryos. Dolly was the first mammal to be cloned from a specialized adult cell.

Embryonic stem cells, which form right after fertilization, can turn into any kind of cell in the body. After they modify into specific types of cells, like neurons or blood cells, they're call specialized cells. Since the cell that gave rise to Dolly was already specialized for its role as a mammary gland cell, most scientists thought it would be impossible to clone anything from it but other mammary gland cells. Dolly proved them wrong.

Many scientists in the '90s were flabbergasted. Dollys advent showed that specialized cells could be used to create an exact replica of the animal they came from. It means all science fiction is true, biology professor Lee Silver of Princeton University told The New York Times in 1997.

The Washington Post reported that "Dolly, depending on which commentator you read, is the biggest story of the year, the decade, even the century. Wilmut has seen himself compared with Galileo, with Copernicus, with Einstein, and at least once with Dr. Frankenstein."

Scientists, lawmakers, and the public quickly imagined a future shaped by unethical human cloning. President Bill Clinton called for review of the bioethics of cloning and proposed legislation that would ban cloning meant ''for the purposes of creating a child (it didn't pass). The World Health Organization concluded that human cloning was "ethically unacceptable and contrary to human integrity and morality" [PDF]. A Vatican newspaper editorial urged governments to bar human cloning, saying every human has "the right to be born in a human way and not in a laboratory."

Meanwhile, some scientists remained unconvinced about the authenticity of Wilmut and Campbells experiment. Norton Zinder, a molecular genetics professor at Rockefeller University, called the study published in Nature "a bad paper" because Dolly's genetic ancestry was not conclusive without testing her mitochondriaDNA that is passed down through mothers. That would have confirmed whether Dolly was the daughter of the sheep that gave birth to her. In The New York Times, Zinder called the Scottish pair's work ''just lousy science, incomplete science." But NIH director Harold Varmus toldthe Times that he had no doubt that Dolly was a clone of an adult sheep.

Because she was cloned from a mammary gland cell, Dolly was nameddad joke alertafter buxom country music superstar Dolly Parton. (Parton didnt mind the attribution.) Like her namesake, Dolly the sheep was a bona fide celebrity: She posed for magazines, including People; became the subject of books, journal articles, and editorials; had an opera written about her; starred in commercials; and served as a metaphor in an electoral campaign.

And that wasn't all: New York Times reporter Gina Kolata, one of the first journalists to give readers an in-depth look at Dolly, wroteClone: The Road to Dolly, and the Path Ahead and contrasted the animal's creation with the archetypes in Frankenstein and The Island of Dr. Moreau. American composer Steve Reich was so affected by Dolly's story that he featured it in Three Tales, a video-opera exploring the dangers of technology.

The sheep also became an inadvertent political player when the Scottish National Party used her image on posters to suggest that candidates of other parties were all clones of one another. Appliance manufacturer Zanussi used her likeness for a poster with her name and the provocative caption "The Misappliance of Science" (the poster was later withdrawn after scientists complained). In fact, so widespread was the (mis)use of her name that her makers eventually trademarked it to stop the practice.

Following Dolly, many larger mammals were cloned, including horses and bulls. Roslin Biomed, set up by the Roslin Institute to focus on cloning technology, was later sold to the U.S.-based Geron Corporation, which combined cloning technology with stem cell research. But despite her popularityand widespread fearDolly's birth didn't lead to an explosion in cloning: Human cloning was deemed too dangerous and unethical, while animal cloning was only minimally useful for agricultural purposes. The sheep'sreal legacy is considered to be the advancement in stem cell research.

Dollys existence showed it was possible to change one cells gene expression by swapping its nucleus for another. Stem cell biologist Shinya Yamanaka told Scientific American that Dollys cloning motivated him to successfully develop stem cells from adult cells. He later won a Nobel Prize for his results, called induced pluripotent stem cells (iPS) because they're artificially created and can have a variety of uses. They reduced the need for embryonic stem cells in research, and today, iPS cells form the basis for most stem cell research and therapies, including regenerative medicine.

Dolly had sixoffspring, and led a productive, sociable life with many human fans coming to visit her. In 2003, a veterinary examination showed that Dolly had a progressive lung disease, and she was put down. But four clonescreated from the same cell line in 2007 faced no such health issues and aged normally.

Dolly is still a spectacle, though, nearly 25 years after her creation: Her body was taxidermied and puton display at the National Museum of Scotland in Edinburgh.

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Dolly the Sheep: '90s Media Sensation - Mental Floss

Yufan inks deal with Abound to develop antibodies directing CAR T cells against cancer targets – BioWorld Online

HONG KONG Xian, China-based Yufan Biotechnologies Co. Ltd. has partnered with Pittsburgh-based Abound Bio Inc. to discover and develop antibodies directing CAR T cells against cancer targets.

The three-year partnership will see the two companies incorporate antibodies for novel cancer targets into the enhanced, HPK1 (hematopoietic progenitor kinase 1)-inhibited CAR T-cell platform, they said. The agreement covers 10 cancer targets, including difficult to treat solid tumors such as liver cancer, Abounds CEO John Mellors told BioWorld.

Although both companies declined to reveal financial details, Mellors said, I calculate that Yufans technology added to Abounds antibodies gives a value greater than two." Yufan declined to comment for the article, but CEO Yan Zhang said, "The partnership with Abound will improve CAR T-cell products for cancer therapy.

The two companies will also share expertise and any potential commercial upside, as well as inventorship and development rights. Yufan definitely benefits, both financially and non-financially, particularly via development rights in China, Mellors said.

The companies will conduct preclinical, then clinical testing of the new CAR T cells against solid tumors, with trials expected to start in the first or second quarter of 2021, Mellors said. They will target the greater China market initially, with the rest of the world to follow. No other firms have been targeted as future partners yet.

Academic roots

The partnership between Yufan and Abound started with an academic collaboration between the National Cancer Institute and Tsinghua University, based on the work led by the universitys professor of pharmaceutical science, Xuebin Liao, who co-founded Yufan along with Zhang. That work demonstrated that HPK1 promotes T-cell exhaustion through NFkB-Blimp1 activation, and that blocking HPK1, via either gene knockout or small-molecule inhibitors, improves CAR T-cell immunotherapy.

Yufan was founded in July 2016 as part of the Xi'an Hi-tech Industries Development Zone Central Organization Departments Thousand Talents program. It focuses on upstream technology development, services and antibody screening for immuno-oncology therapy. The company is developing CAR T cells with a deleted HKP1 gene to prevent cell exhaustion, with a first-in-human clinical study of the XYF-19 HPK1 knockout CD19 CAR T product currently underway in patients with relapsed or refractory CD19+ leukemia or lymphoma.

Other projects include CAR T-cell therapy, CAR T-cell GMP production, immune cell gene editing CRISPR/Cas9 technology, a phage antibody library, phage display technology, and the buildout of a human antibody screening platform. The company is currently collaborating with the Air Force Military Medical Universitys Xijing Hospital on an investigational CAR T-cell therapy.

Yufan plans to invest 100 million (US$14.72 million) to build manufacturing facilities for CAR T-cell therapies to treat refractory and relapsed leukemia and lymphoma and expects to generate annual sales of between 200 million to 400 million once those candidates reach market.

Across the Pacific, Abound is an early stage biotechnology company developing antibody-based biological therapeutics for cancer and infectious diseases.

One infectious disease that the company is concentrating on is COVID-19, with the number of global cases topping 35 million as of Oct. 5, according to Johns Hopkins University data. An Abound team led by Mellors and the companys chief scientific officer, Dimiter Dimitrov, discovered human monoclonal antibodies with neutralizing activity in the laboratory against SARS-CoV-2, the virus that causes COVID-19, from antibody libraries.

Although the antibodies have proved effective in low doses in mouse and hamsters, human trials have not yet started. However, the antibodies are ready for testing in CAR T cells in preclinical models, and we hope to rapidly progress to clinical studies, Mellors said.

The company is currently proceeding with production and clinical development for regulatory approval and commercialization in the MENA and ASEAN regions, clinching an agreement with Saudi-U.S. joint venture Saudivax earlier in the year.

The Yufan-Abound partnership also aims to tap the lucrative T-cell market, which was valued at $2.7 billion in 2017 and is expected to reach $8.21 billion in 2025, growing at a compounded annual growth rate (CAGR) of 14.9% between 2017 and 2025, according to Frost & Sullivans report Growth Opportunities in the Global Cell Therapy Market, Forecast to 2025.

Amendments in regulatory and reimbursement policies, as well as the implementation of conditional approval policies for regenerative medicine, will further drive the market by expediting product launches, Aarti Chitale, Frost & Sullivan senior research analyst for transformational health, wrote. Additionally, improvements in cell culturing techniques alongside the use of different stem cells such as adipose-derived stem cells, mesenchymal stem cells, and induced pluripotent stem cells will strengthen the market with superior treatment options for non-oncological conditions such as neurological, musculoskeletal, and dermatological conditions, she added.

Excerpt from:
Yufan inks deal with Abound to develop antibodies directing CAR T cells against cancer targets - BioWorld Online

Allele Biotechnology and Pharmaceuticals Files Two Lawsuits for Patent Infringement for the Unauthorized Use of mNeonGreen in Development and Testing…

Oct. 6, 2020 01:40 UTC

SAN DIEGO--(BUSINESS WIRE)-- Allele Biotechnology and Pharmaceuticals, Inc. (Allele), a San Diego-based company focused on developing and adapting cutting edge technology for clinical and therapeutic use, filed two patent infringement lawsuits today one in New York against Regeneron Pharmaceuticals and the other in California against Pfizer and BioNTech. Both complaints address the infringement of Alleles patented mNeonGreen technology, an important reagent used in the development of therapeutics for COVID-19.

Alleles mNeonGreen protein is considered the worlds brightest monomeric fluorescent protein, and the technology behind that protein was patented in 2019. Prominent scientific journals have touted the use of mNeonGreen as the gold standard for use in assays testing neutralizing antibody and vaccine candidates. Regeneron, Pfizer, and BioNTech used mNeonGreen commercially without authorization from Allele.

I am pleased that mNeonGreen has played a pivotal role in the fight against COVID-19. In no way does Allele want to prohibit, or slow down development of vaccines or therapeutics discovered using this technology, says Dr. Jiwu Wang, Founder and CEO of Allele. Our goal is to have these companies recognize, as many others have before them, the hard work that went in to developing this technology and to respect our intellectual property.

Hundreds of organizations and universities have active licenses to use Alleles mNeonGreen technology. According to the complaint, Allele reached out to Regeneron on multiple occasions to negotiate a license on reasonable terms, but all of its requests went unanswered. In fact, no defendant sought any permission in advance of using mNeonGreen to obtain breakthrough successes in developing and testing their vaccines.

The purpose of these lawsuits is to maintain Allele's patent rights and to ensure that an agreement can be put in place to protect the rights of current and future licensees, says Dan Catron, Executive Director, Licensing and Business Development for Allele.

Perkins Coie LLP is representing Allele in the New York filing. Troutman Pepper Hamilton Sanders LLP is representing Allele in the California lawsuits.

About Allele Biotechnology and Pharmaceuticals Inc.

Established in 1999, Allele Biotechnology has focused on developing and adapting cutting edge technology for clinical and therapeutic use. Allele has worked on biological advancements that have been at the forefront of molecular biology research, including RNA interference, fluorescent proteins, induced Pluripotent Stem Cells (iPSCs), and camelid-derived, single-domain nanoantibodies. With the advent of the global pandemic, Allele initiated the development of a series of llama nanoantibodies against SARS-CoV-2, the virus responsible for COVID-19. To learn more, go to https://www.allelebiotech.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201005005984/en/

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Allele Biotechnology and Pharmaceuticals Files Two Lawsuits for Patent Infringement for the Unauthorized Use of mNeonGreen in Development and Testing...

Huge Investment in Induced Pluripotent Stem Cells Market Expected to Witness the Highest Growth 2026 | Fujifilm Holding Corporation (CDI) Ncardia,…

Induced Pluripotent Stem Cells Market has been growing exponentially over time and has shown great potential in the near future. The growth of Induced Pluripotent Stem Cells Market is expected to see an amazing uproar as the market becomes increasingly popular. The report focuses on the key growth contributors of the market to help the clients better understand the current scenario of the market all while considering the history as well as the forecast of the Induced Pluripotent Stem Cells Market. Essential growth factors have been discussed in the following report.

Top Companies covering This Report :- Fujifilm Holding Corporation (CDI), Ncardia, Sumitomo Dainippon Pharma, Astellas Pharma Inc, Fate Therapeutics, Inc, Pluricell Biotech, , Cell Inspire Biotechnology, ReproCELL.

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Human iPSCs Mouse iPSCs

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Europe, Middle East and Africa (Germany, France, UK, Russia and Italy, Saudi Arabia, UAE, Egypt, Nigeria, South Africa)

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Huge Investment in Induced Pluripotent Stem Cells Market Expected to Witness the Highest Growth 2026 | Fujifilm Holding Corporation (CDI) Ncardia,...

Stem Cell-Derived Cells Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 – 2029 – Stock Market Funda

In this report, the global Stem Cell-Derived Cells market is valued at USD XX million in 2019 and is projected to reach USD XX million by the end of 2025, growing at a CAGR of XX% during the period 2019 to 2025.

Persistence Market Research recently published a market study that sheds light on the growth prospects of the global Stem Cell-Derived Cells market during the forecast period (20XX-20XX). In addition, the report also includes a detailed analysis of the impact of the novel COVID-19 pandemic on the future prospects of the Stem Cell-Derived Cells market. The report provides a thorough evaluation of the latest trends, market drivers, opportunities, and challenges within the global Stem Cell-Derived Cells market to assist our clients arrive at beneficial business decisions.

The Stem Cell-Derived Cells market report firstly introduced the basics: definitions, classifications, applications and market overview; product specifications; manufacturing processes; cost structures, raw materials and so on. Then it analyzed the worlds main region market conditions, including the product price, profit, capacity, production, supply, demand and market growth rate and forecast etc. In the end, the Stem Cell-Derived Cells market report introduced new project SWOT analysis, investment feasibility analysis, and investment return analysis.

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Resourceful insights enclosed in the report:

The major players profiled in this Stem Cell-Derived Cells market report include:

key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.

The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:

Segmentation by Product Type

Segmentation by End User

The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.

North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.

Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

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The market report addresses the following queries related to the Stem Cell-Derived Cells market:

The study objectives of Stem Cell-Derived Cells Market Report are:

To analyze and research the Stem Cell-Derived Cells market status and future forecast in United States, European Union and China, involving sales, value (revenue), growth rate (CAGR), market share, historical and forecast.

To present the Stem Cell-Derived Cells manufacturers, presenting the sales, revenue, market share, and recent development for key players.

To split the breakdown data by regions, type, companies and applications

To analyze the global and key regions Stem Cell-Derived Cells market potential and advantage, opportunity and challenge, restraints and risks.

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Stem Cell-Derived Cells Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 - 2029 - Stock Market Funda

Kyoto University project aims to supply iPS cells widely at low cost – The Japan Times

Kyoto A project to make induced pluripotent stem cells, known as iPS cells, promptly and widely available at lower cost will get underway next year.

The My iPS Project will feature the creation of iPS cells, which can change into various types of functional cells, from the blood or other tissues of the patients themselves, to avoid rejection when a transplant is performed.

The project will be led by the CiRA Foundation at Kyoto University, which has taken over the business of stockpiling iPS cells from the university's Center for iPS Research and Application.

Headed by Shinya Yamanaka, a stem cell researcher and professor at the university who was awarded the Nobel Prize in Physiology or Medicine in 2012 for his pioneering work in iPS cell technology, the foundation was set up in September 2019 to make the business an independent operation financed by earnings and donations. It became a public interest foundation in April.

When a transplant is performed, the rejection of cells occurs if human leukocyte antigen, or HLA, from the donor is different from that of the recipient.

But with iPS cells produced from a person who has inherited the same type of HLA from his or her parents, rejection is considered rare for cells transplanted in another person with the same type of the antigen.

Using this knowledge, CiRA at Kyoto University has produced 27 kinds of iPS cells from the blood of seven healthy people and supplied them to research institutions and private companies for use in clinical studies and trials to facilitate regenerative medicine.

In 2017, research institutions such as Riken transplanted retina cells produced from the iPS cells in five patients suffering from intractable eye diseases. The first transplants of their kind in the world were followed by the transplants of nerve cells to the brain of a Parkinson's disease patient at Kyoto University and of a cardiac muscle sheet to a cardiac patient at Osaka University.

But the iPS cells stored by CiRA are of four kinds in terms of HLA type, estimated to eliminate rejection for only about 40 percent of all transplants for Japanese people. At CiRA, furthermore, iPS cells are manually cultivated by three well-trained people who are also responsible for preventing the entry of impurities and checking quality.

CiRA, therefore, can produce iPS cells only for three patients per year and transplants cost 40 million per person.

To reduce rejection, the foundation will develop technology to culture iPS cells from the blood or other tissues of the patients themselves and lower the cost of transplants. Starting in 2021, it will build a facility for automated processes from cultivation to inspection to stockpiling.

The project will be financed from the 5 billion that Tadashi Yanai, president and chairman of Fast Retailing Co., has pledged to donate to Kyoto University over 10 years.

The facility, with a total floor space of 1,500 square meters, will have many cylindrical, automated incubators as tall as human beings. It is planned to be completed in January 2025 so that its technology can be exhibited at the World Exposition to be held in Osaka in the year. To show appreciation for the donation, the facility will carry the name Yanai.

The project will realize the "ideal use" of iPS cells, Yamanaka said, declaring the aim of supplying them to 1,000 patients per year at 1 million per person.

Originally posted here:
Kyoto University project aims to supply iPS cells widely at low cost - The Japan Times

ONLINE: The Future of Medicine – Isthmus

Watch here: https://www.youtube.com/watch?feature=youtu.be&v=VVkQU91KbEs

press release: The UW has a long history of pioneering medical advancements that have transformed the world. From performing the first bone marrow transplant in the United States to cultivating the first laboratory-derived human embryonic stem cells. Now, where will UW medical research go next?

On the next Wisconsin Medicine Livestream, meet trailblazing doctors, researchers, and medical leaders who are charting a bold course to completely alter the health care landscape. During this insightful panel discussion, well explore how gene therapy and cell replacements could hold the keys to treating inherited and acquired blindness. Youll also discover the remarkable potential in xenotransplantation where nonhuman animal source organs are transplanted into human recipients. In addition, you will learn about UW Healths journey to build a multidisciplinary program to serve the community. These, and other, fascinating developments in treatment and care are happening right now at the UW and are the future of medicine. The presentation will be moderated by Robert Golden, the dean of the University of WisconsinMadisons School of Medicine and Public Health.

Our Guests:

David Gamm, professor, Department of Ophthalmology and Visual Sciences; Emmett A. Humble Distinguished Director, McPherson Eye Research Institute; Sandra Lemke Trout Chair in Eye Research

Dr. Gamms lab is at the forefront in developing cell-based therapies to combat retinal degenerative diseases (RDDs). As the director of the McPherson Eye Research Institute and a member of the Waisman Center Stem Cell Research Program, the UW Stem Cell and Regenerative Medicine Center, and the American Society for Clinical Investigation, his efforts are directed toward basic and translational retinal stem cell research. The Gamm Lab uses induced pluripotent stem cells to create retinal tissues composed of authentic human photoreceptor cells rods and cones that can detect light and initiate visual signals in a dish. The aims of his laboratory are to investigate the cellular and molecular events that occur during human retinal development and to generate cells for use in retinal disease modeling and cell replacement therapies. In collaboration with other researchers at UWMadison and around the world, the lab is developing methods to produce and transplant photoreceptors and/or retinal pigment epithelium (RPE) in preparation for future clinical trials. At the same time, the Gamm Lab uses lab-grown photoreceptor and RPE cells to test and advance a host of other experimental treatments, including gene therapies. In so doing, the lab seeks to delay or reverse the effects of blinding disorders, such as retinitis pigmentosa and age-related macular degeneration, and to develop or codevelop effective interventions for these RDDs at all stages of disease.

Dhanansayan Shanmuganayagam, assistant professor, Department of Surgery, School of Medicine and Public Health; Department of Animal and Dairy Sciences, UWMadison; director, Biomedical, and Genomic Research Group

Dr. Shanmuganayagams research focuses on the development and utilization of pigs as homologous models to close the translational gap in human disease research, taking advantage of the overwhelming similarities between pigs and humans in terms of genetics, anatomy, physiology, and immunology. He and his colleagues created the human-sized Wisconsin Miniature Swine breed that is unique to the university. The breed exhibits greater physiological similarity to humans, particularly in vascular biology and in modeling metabolic disorders and obesity. He currently leads genetic engineering of swine at the UW. His team has created more than 15 genetic porcine models including several of pediatric genetic cancer-predisposition disorders such as neurofibromatosis type 1 (NF1). In the context of NF1, his lab is studying the role of alternative splicing of the nf1 gene on the tissue-specific function of neurofibromin and whether gene therapy to modulate the regulation of this splicing can be used as a viable treatment strategy for children with the disorder.

Dr. Shanmuganayagam is also currently leading the efforts to establish the University of Wisconsin Center for Biomedical Swine Research and Innovation (CBSRI) that will leverage the translatability of research in pig models and UWMadisons unique swine and biomedical research infrastructure, resources, and expertise to conduct innovative basic and translational research on human diseases. The central mission of CBSRI is to innovate and accelerate the discovery and development of clinically relevant therapies and technologies. The center will also serve to innovate graduate and medical training. As the only center of its kind in the United States, CBSRI will make UWMadison a hub of translational research and industry-partnered biomedical innovation.

Petros Anagnostopoulos, surgeon in chief, American Family Childrens Hospital; chief, Section of Pediatric Cardiothoracic Surgery; professor, Department of Surgery, Division of Cardiothoracic Surgery

Dr. Anagnostopoulos is certified by the American Board of Thoracic Surgery and the American Board of Surgery. He completed two fellowships, one in cardiothoracic surgery at the University of Pittsburgh School of Medicine and a second in pediatric cardiac surgery at the University of California, San Francisco School of Medicine. He completed his general surgery residency at Henry Ford Hospital in Detroit. Dr. Anagnostopoulos received his MD from the University of Athens Medical School, Greece. His clinical interests include pediatric congenital heart surgery and minimally invasive heart surgery.

Dr. Anagnostopoulos specializes in complex neonatal and infant cardiac reconstructive surgery, pediatric heart surgery, adult congenital cardiac surgery, single ventricle palliation, extracorporeal life support, extracorporeal membrane oxygenation, ventricular assist devices, minimally invasive cardiac surgery, hybrid surgical-catheterization cardiac surgery, off-pump cardiac surgery, complex mitral and tricuspid valve repair, aortic root surgery, tetralogy of Fallot, coronary artery anomalies, Ross operations, obstructive cardiomyopathy, and heart transplantation.

When: Tuesday, Sept. 29, at 7 p.m. CDT

Where: Wisconsin Medicine Livestream: wiscmedicine.org/programs/ending-alzheimers

Continued here:
ONLINE: The Future of Medicine - Isthmus

funded study sheds light on abnormal neural function in rare genetic disorder – National Institutes of Health

News Release

Monday, September 28, 2020

Findings show deficits in the electrical activity of cortical cells; possible targets for treatment for 22q11.2 deletion syndrome.

A genetic study has identified neuronal abnormalities in the electrical activity of cortical cells derived from people with a rare genetic disorder called 22q11.2 deletion syndrome. The overexpression of a specific gene and exposure to several antipsychotic drugs helped restore normal cellular functioning. The study, funded by the National Institutes of Health (NIH) and published in Nature Medicine, sheds light on factors that may contribute to the development of mental illnesses in 22q11.2 deletion syndrome and may help identify possible targets for treatment development.

22q11.2 deletion syndrome is a genetic disorder caused by the deletion of a piece of genetic material at location q11.2 on chromosome 22. People with 22q11.2 deletion syndrome can experience heart abnormalities, poor immune functioning, abnormal palate development, skeletal differences, and developmental delays. In addition, this deletion confers a 20-30% risk for autism spectrum disorder (ASD) and an up to 30-fold increase in risk for psychosis. 22q11.2 deletion syndrome is the most common genetic copy number variant found in those with ASD, and up to a quarter of people with this genetic syndrome develop a schizophrenia spectrum disorder.

This is the largest study of its type in terms of the number of patients who donated cells, and it is significant for its focus on a key genetic risk factor for mental illnesses, said David Panchision, Ph.D., chief of the Developmental Neurobiology Program at the NIHs National Institute of Mental Health. Importantly, this study shows consistent, specific patient-control differences in neuronal function and a potential mechanistic target for developing new therapies for treating this disorder.

While some effects of this genetic syndrome, such as cardiovascular and immune concerns, can be successfully managed, the associated psychiatric effects have been more challenging to address. This is partly because the underlying cellular deficits in the central nervous system that contribute to mental illnesses in this syndrome are not well understood. While recent studies of 22q11.2 deletion syndrome in rodent models have provided some important insights into possible brain circuit-level abnormalities associated with the syndrome, more needs to be understood about the neuronal pathways in humans.

To investigate the neural pathways associated with mental illnesses in those with 22q11.2 deletion syndrome, Sergiu Pasca, M.D., associate professor of psychiatry and behavioral sciences at Stanford University, Stanford, California, along with a team of researchers from several other universities and institutes, created induced pluripotent stems cells cells derived from adult skin cells reprogramed into an immature stem-cell-like state from 15 people with 22q11.2 deletion and 15 people without the syndrome. The researchers used these cells to create, in a dish, three-dimensional brain organoids that recapitulate key features of the developing human cerebral cortex.

What is exciting is that these 3D cellular models of the brain self-organize and, if guided to resemble the cerebral cortex, for instance, contain functional glutamatergic neurons of deep and superficial layers and non-reactive astrocytes and can be maintained for years in culture. So, there is a lot of excitement about the potential of these patient-derived models to study neuropsychiatric disease, said Dr. Pasca.

The researchers analyzed gene expression in the organoids across 100 days of development. They found changes in the expression of genes linked to neuronal excitability in the organoids that were created using cells from individuals with 22q11.2 deletion syndrome. These changes prompted the researchers to take a closer look at the properties associated with electrical signaling and communication in these neurons. One way neurons communicate is electrically, through controlled changes in the positive or negative charge of the cell membrane. This electrical charge is created when ions, such as calcium, move into or out of the cell through small channels in the cells membrane. The researchers imaged thousands of cells and recorded the electrical activity of hundreds of neurons derived from individuals with 22q11.2 deletion syndrome and found abnormalities in the way calcium was moved into and out of the cells that were related to a defect in the resting electrical potential of the cell membrane.

A gene called DGCR8 is part of the genetic material deleted in 22q11.2 deletion syndrome, and it has been previously associated with neuronal abnormalities in rodent models of this syndrome. The researchers found that heterozygous loss of this gene was sufficient to induce the changes in excitability they had observed in 22q11.2-derived neurons and that overexpression of DGCR8 led to partial restoration of normal cellular functioning. In addition, treating 22q11.2 deletion syndrome neurons with one of three antipsychotic drugs (raclopride, sulpiride, or olanzapine) restored the observed deficits in resting membrane potential of the neurons within minutes.

We were surprised to see that loss in control neurons and restoration in patient neurons of the DGCR8 gene can induce and, respectively, restore the excitability, membrane potential, and calcium defects, said Pasca. Moving forward, this gene or the downstream microRNA(s) or the ion channel/transporter they regulate may represent novel therapeutic avenues in 22q11.2 deletion syndrome.

Grants:MH107800; MH100900; MH085953; MH060233; MH094714

About the National Institute of Mental Health (NIMH):The mission of theNIMHis to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit theNIMH website.

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

Khan, T. A., Revah, O., Gordon, A., Yoon, S., Krawisz, A. K., Goold, C., Sun, Y., Kim, C., Tian, Y., Li, M., Schaepe, J. M., Ikeda, K., Amin, N. D., Sakai, N., Yazawa, M., Kushan, L., Nishino, S., Porteus, M. H., Rapoport, J. L. Paca, S. (2020). Neuronal defects in a human cellular model of 22q11.2 deletion syndrome. Nature Medicine. doi: 10.1038/s41591-020-1043-9

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funded study sheds light on abnormal neural function in rare genetic disorder - National Institutes of Health

The new pharma collaborations driving transformative research in oncology – – pharmaphorum

The pharmaceutical industry is one of the most scientifically innovative and competitive industries, particularly in oncology. As of 2018, there were over 1,100 cancer therapies in development, and as of 2020, 362 of them were cell and gene therapies. As a result, there is a need for continued innovation and increased efficiency in terms of drug development to manage cost, complexity and speed to provide potentially transformative therapies for cancer patients.

Within the last two decades, large pharmaceutical corporations have established themselves firmly in oncology by prioritising internal R&D efforts, as well as developing and accessing novel science and technology through collaborations and alliances with biotech companies and academic institutions.

Dramatic advances in the understanding of basic molecular mechanisms of underlying disease has continued to shift R&D focus toward precision medicine choosing the right therapy for a patient based on molecular understanding of their disease and less on traditional cancer therapies such as cytotoxic chemotherapies and broad-cell cycle inhibitors.

As a result of this shift in drug development, a highly concentrated overlay in product modalities and mechanisms of action has crowded the oncology pipeline across a very broad range of hematological and solid tumour indications.

The industry is asking itself how to stay innovative, how to develop and bring to market higher quality therapies to patients and how to do this faster and more efficiently.

A diversity of collaboration types

There is broad recognition that given the breadth and complexity of emerging science driving innovation in oncology, collaborations are essential in order that relevant expertise, know-how and capabilities can be combined in the right way to address patient needs.

Such collaborations take on many forms, ranging from early, multi-party alliances and consortia which are often pre-competitive in nature driving the development and shared learnings from technologies that may be enabling the field as a whole, through to more bespoke collaborations between entities.

Cell therapy research has been built on collaborations amongst scientists and entrepreneurs, providing early proof of concept for modalities thought to be too difficult to commercialise but with a strong potential for patient benefit

These may be more focused on collaborative research and development of novel products, to secure the necessary data for regulatory approvals to make such products available widely to the patients who can benefit from them.

Pre-competitive collaborations, often in basic and preclinical research, can reduce the barrier of competition and drive benefits for all stakeholders, most notably, the patient. As summarised by The National Institutes of Health, this includes reducing the number of redundant clinical trials, enhancing the statistical strength of studies, reducing overall costs and risks, and improving study participant recruitment, all while triggering creativity and innovation between collaborators.

These benefits strengthen capabilities and accelerate product development, ultimately producing higher quality and more effective therapies.

One powerful example is The National Institutes of Healths Partnership for Accelerating Cancer Therapies (PACT), which brought together 11 pharmaceutical companies to accelerate the development of new cancer immunotherapies.

Aligning with the focus of the Cancer Moonshot Research Initiative, PACT aimed to retrospectively analyse patient data from past clinical trials with the goal of predicting future patient outcomes.

This type of approach supports the ability to compare data across all trials and facilitates information sharing between partners, undoubtedly accelerating the pathway to effective therapies.

A second example is the establishment of The Parker Institute for Cancer Immunotherapy, to enable leading academic researchers and companies to come together in a pre-competitive setting, to enable rapid shared understanding and development of immunotherapeutic approaches, including the study of combination regimens.

Such combination trials, particularly those encompassing investigational products, have historically been challenging to undertake given the need for bespoke company-to-company and other 1:1 collaborative agreements. Bringing together multiple academic and industry participants under an open innovation model provides a basis to significantly accelerate the generation of scientific and clinical data that may substantially inform the field of cancer immunotherapy as a whole.

Oncology cell therapy research has been built on foundational academic collaborations amongst scientists and entrepreneurs, providing early proof of concept for modalities thought to be too difficult to commercialise but with a strong potential for patient benefit.

Examples include Kite Pharma, formed from the foundational work at the National Cancer Institute, Juno from the collaboration between the Fred Hutchinson Cancer Center and Memorial Sloan Kettering Cancer Center (all working on the first CAR T-cell candidates), or Adaptimmune working with University of Penn to first show efficacy of optimised TCR T-cells.

For collaborations that are more geared to development of novel therapies, aiming for regulatory approval and commercial availability, bespoke collaborations between biotech and pharma companies are commonplace, whereby the respective expertise and capabilities of each partner are combined in order to optimise and accelerate development, and to enable subsequent, larger scale manufacture and distribution. There are many examples of such collaborations, for which the structure can vary widely depending on the expertise of each partner, and the collaborative ways of working.

For example, under a traditional pharma/biotech collaboration and licensing model, a biotech partner may have primary responsibility for significant elements of research and early product development, and the pharma partner may lead the majority of later stage development, as well as post-approval commercial manufacture and supply. This logically aligns with organisational expertise and scale, and this type of collaboration structure has historically proven to work well. Many novel therapies have been successfully developed through such partnerships.

The rapid emergence of cell and gene therapy has required the industry to establish new and distinct capabilities, such as optimal process development and manufacture of autologous, patient specific cell therapies, whilst minimising the vein-to-vein time (the elapsed time between apheresis treatment for a patient, and reinfusing the final autologous manufactured product).

There are a growing number of biotech and pharma companies that have established or are establishing such end-to-end cell therapy capabilities, which can also play into how collaborations are structured in the field.

Case Study: From Technology Agreement to co-development and co-commercialisation partnership

In 2015, Adaptimmune and Universal Cells signed an agreement to drive the development of technologies leveraging gene-edited Induced Pluripotent Stem Cell (iPSC) lines, towards the development of allogeneic, or off-the-shelf, T-cell therapies. Universal Cells brought leading gene editing capability to make targeted gene edits to modify the characteristics of selected iPSC cell lines, and Adaptimmune the technology to differentiate iPSCs into T-cells.

Back then the science for this collaboration was early and under-developed with both parties embarking on a long-term effort and making significant at-risk investments to determine if edited, functional T-cells could be produced.

Today, Universal Cells (now an Astellas company) and Adaptimmune have established capabilities and expertise to progress novel cell therapies into clinical development, as well as with manufacturing and supply chain.

Based on this progress, in January 2020, Adaptimmune and Astellas signed a product-focused agreement to co-develop and co-commercialise up to three new stem-cell derived allogeneic T-cell therapies for people with cancer.

Given the scientific synergy between Universal Cells and Adaptimmune, and that each company is developing capabilities that may effectively address later stage product development and post-approval commercial supply, the 2020 partnership was structured as a co-development and co-commercialisation agreement. It enables the companies to work closely together, throughout the continuum of research, development and commercialisation.

Astellas and Adaptimmune will collaborate through to the end of phase 1, with Universal Cells leading gene editing activities and Adaptimmune leading iPSC to T-cell differentiation, early product characterisation and development. Beyond that, Astellas and Adaptimmune will decide whether to develop and commercialise a product candidate together under a co-development and co-commercialisation cost and profit-sharing arrangement, or for one company to take it forward alone.

This partnership is an example of how companies can harness their individual science and bring together highly complementary skills and expertise. It will enable the development of new, off-the-shelf T-cell therapies for people with cancer, which could potentially offer significant advantages such as broader access, reduced vein-to-vein time, and lower cost. The co-development and co-commercialisation nature of the agreement allows both companies to collaborate closely and on a long term basis, whilst leveraging end-to-end capabilities established by each company, maximising the velocity of product development, and ultimately delivering novel therapies to patients.

This type of agreement exemplifies how early speculative scientific collaboration can benefit all parties, most importantly the patient. It is one example from many in oncology, that underlines the value of long-term partnership within a field that is evolving rapidly across many scientific, operational and commercial frontiers.

Bringing together both teams of passionate and forward-thinking scientists may contribute to unlocking the current opportunities and challenges of off-the-shelf T-cell therapy development more effectively and efficiently for patients.

Similarly to what we are seeing as the world comes together to fight COVID-19, we as leaders in oncology owe it to patients to constantly look for ways to bring our innovative ideas as quickly as possible to the market. Working together might make that happen faster.

About the author

Helen Tayton-Martin is chief business officer at Adaptimmune.

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The new pharma collaborations driving transformative research in oncology - - pharmaphorum