Category Archives: Induced Pluripotent Stem Cells


Manufacturing a Personalized Cellular Universe: 3D Bioprinting in the Biotech Industry – BioSpace

Tissues in the body work as a complex team of interconnected cells. For instance, the heart is comprised of contractile cardiomyocytes, along with a vast array of endothelial cells, immune cells and fibroblasts. Similarly, the liver includes hepatocytes, immune cells, endothelial cells and epithelial cells. Put in all the cellular players, and the team wins. Take out one player, and the team is no longer able to sufficiently function.

The field of 3D bioprinting draws deeply on this idea of optimizing tissue regeneration and replacement. By using naturally-derived scaffolds, human cells and other biocompatible materials, 3D bioprinting has ushered in opportunities for researchers to design, print and optimize patient personalized tissues for purposes ranging from transplantation to drug testing.

The current drug development process is extremely lengthy and costly due to the lack of proper tools for preclinical drug screening, said Dr. Wei Zhu, CEO of Allegro 3D, a San Diego-based bioprinting company. What excites us most about 3D bioprinting is its potential to provide a paradigm shift in the drug discovery and screening process.

The bioprinting process is analogous to a Build-A-Bear factory but while a teddy bear contains carefully chosen ribbons, buttons and stuffing, 3D bioprinting creates complex tissues possibly derived from a patients own cells. In both cases, integrating customized components allows for layer-by-layer formation of something unique, yet fully functional.

While the techniques used for 3D bioprinting have mechanical grounding in traditional printing, the defining characteristic of 3D bioprinting is the usage of bioinks. Bioinks are complex, optimized mixtures of solution matrices containing carrier molecules and additional supporting agents. Often, the solution material is a biopolymer a naturally-derived gel, used to envelop the cells as a 3D molecular scaffold. Common biomaterials include gelatin, hyaluronic acid and alginate, all of which retain a high degree of biocompatibility. They provide a supporting structure, as well as a nurturing environment for future cellular growth and differentiation.

Historically, 3D bioprinting has become possible through three main modalities: light-based bioprinting, inkjet bioprinting and extrusion based bioprinting. Light-based bioprinting utilizes a light source, which can often be a blue LED, to cure photo-polymerizable bioinks into a more solidified scaffold. Inkjet bioprinting, on the other hand, is analogous to the conventional desktop printer, where bioink droplets are positioned on a receiving substrate based on computer control. Finally, extrusion based bioprinting relies on pressure to mechanically dispense bioinks by syringe extrusion onto receiving substrates.

Each technique has its own unique advantages. For example, light-based bioprinting allows for an incredible degree of precision, resolution and speed resulting in the possibility of micro or nanopatterning in a rapid fashion. Inkjet or droplet bioprinting is markedly straightforward, with low overall production costs and easy handling. Extrusion-based printing allows for printing with high cell densities.

Allegro 3D finds its niche in the bioprinting industry by providing light-based printing products primarily, their StemakerTMbioprinter and SteminkTMbioinks. Notably, the StemakerTMbioprinter was the worlds first digital light processing (DLP) bioprinter for high throughput tissue printing. Light is applied to the pre-polymer bioink, which photopolymerizes layer-by-layer to encapsulate live cells in the final 3D tissue construct. By using visible light as the photopolymerization source, cell viability remains very high during the manufacturing process. Furthermore, the technique allows for incorporation of various cell types in a single printed scaffold for instance, liver cells in the bottom layer, and endothelial cells in the top layer. With the ability to mix and match various cell types, the complexity and diversity of human tissues is an achievable possibility.

In terms of application, the possibilities of Allegro 3Ds bioprinting techniques have dramatic implications for the biomedical community.

With our StemakerTMbioprinters and SteminkTMbioinks, our customers can print 3D precision human tissues on demand for various biomedical applications, Zhu said. These applications include building tissue samples for disease modeling, providing patient-specific tissues or organs for therapeutic treatment of injuries, and providing 3D human tissues to investigate the toxicity and efficacy of new drug compounds in vitro.

By closely mimicking hepatic lobule structure through an eye-catching pattern of hexagons and circles that looks somewhat like a bees hive, this DLP bioprinter was able to print human liver tissue containing both human induced pluripotent derived stem cells and other supporting cells in seconds. The goal of such constructs would then be to provide easily accessible tissues for high-throughput drug discovery, or to print patient-derived hepatic tissues for liver regeneration.

According to Zhu, a key issue with traditional bioprinting techniques is that of scalability. Pharmaceutical and biotechnology industries often use high-throughput screening instruments for which the needs far exceed the capabilities of traditional bioprinters. The photopolymerization techniques of the StemakerTMbioprinter allow for compatibility with the high-throughput systems, which will greatly help our customers improve the accuracy and efficiency of drug screening and assay development.

On the extrusion-based bioprinting front, Allevi, a 3D bioprinting company based in Philadelphia, focuses on providing universally-friendly extrusion-based bioprinters, bioinks and software. Their latest model, named Allevi 3, contains three extruders through which bioinks can be deposited to form tissue scaffolds. Allevi also offers a wide selection of bioinks, which can be mixed in conjunction with cell populations to be directly utilized in their 3D bioprinters.

Likewise, Cellink, which was the first company to commercialize bioinks, is a Boston-based bioprinting company that has since expanded to provide services ranging from bioprinters to live cell imaging and liquid handling machines. Cellinks bioprinters include extrusion-based printers that contain up to six extruder heads with the BIO X6, as well as light-based printers. Their vast array of automated systems represents a diverse amalgamation of capabilities for more streamlined manufacturing.

Altogether, these 3D bioprinting companies represent a rapidly growing sector of the biotechnology industry. The unmet medical need of human tissue for regeneration, drug testing, and other pharmaceutical purposes remains a key driving force. 3D bioprinting has potential to change the ways in which we discover new, exciting chemical compounds to treat debilitating diseases, or to eliminate the strenuous waiting game experienced by many in need of an organ transplant. With the advent of these technologies, we acknowledge a future where we may potentially design, print and order complex human tissues for life-saving purposes.

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Manufacturing a Personalized Cellular Universe: 3D Bioprinting in the Biotech Industry - BioSpace

Fate Therapeutics Announces Presentations at the 2020 Society for Immunotherapy of Cancer Annual Meeting – GlobeNewswire

October 15, 2020 08:00 ET | Source: Fate Therapeutics, Inc.

SAN DIEGO, Oct. 15, 2020 (GLOBE NEWSWIRE) -- FateTherapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced that five abstracts for the Companys induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the Society for Immunotherapy of Cancer (SITC) annual meeting being held virtually from November 9-14, 2020.

Accepted abstracts include clinical data from 15 patients in the dose-escalation stage of the Companys Phase 1 clinical trial of FT500 in advanced solid tumors (NCT03841110), which includes nine patients in Regimen A (three once-weekly doses of FT500 for up to two 30-day cycles as monotherapy) and six patients in Regimen B (three once-weekly doses of FT500 for up to two 30-day cycles in combination with checkpoint inhibitor therapy). The Company is currently enrolling the dose-expansion stage of the Phase 1 clinical trial for patients with non-small cell lung cancer or classical Hodgkin lymphoma who are refractory to, or have relapsed on, checkpoint inhibitor therapy. Each patient in the dose-expansion stage is to receive three once-weekly doses of FT500 at 300 million cells per dose, each with IL-2 cytokine support, for up to two 30-day cycles in combination with the same checkpoint inhibitor on which the patient failed or relapsed.

Oral Presentation

Poster Presentations

All abstracts are scheduled to be available on the SITC website on November 9, 2020.

About Fate Therapeutics iPSC Product Platform The Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

About FT500 FT500 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line. The product candidate is being investigated in an open-label, multi-dose Phase 1 clinical trial for the treatment of advanced solid tumors (NCT03841110). The study is designed to assess the safety and tolerability of FT500 as a monotherapy and in combination with one of three FDA-approved immune checkpoint inhibitor (ICI) therapies nivolumab, pembrolizumab or atezolizumab in patients that have failed prior ICI therapy. Despite the clinical benefit conferred by approved ICI therapy against a variety of tumor types, these therapies are not curative and, in most cases, patients either fail to respond or their disease progresses on these agents. One common mechanism of resistance to ICI therapy is associated with loss-of-function mutations in genes critical for antigen presentation. A potential strategy to overcome resistance is through the administration of allogeneic NK cells, which have the inherent capability to recognize and directly kill tumor cells with these mutations.

About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Companys immuno-regulatory product candidates include ProTmune, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of, plans related to, and the therapeutic potential of the Company's product candidates, the Companys clinical development strategy and plans for the clinical investigation of its product candidates, and the Companys preclinical research and development programs. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk of difficulties or delay in the initiation of any planned clinical studies, or in the enrollment or evaluation of subjects in any future clinical studies, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, difficulties in manufacturing or supplying the Companys product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that results observed in preclinical studies of the Companys product candidates may not be replicated in ongoing or future clinical trials or studies, and the risk that the Companys product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

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Fate Therapeutics Announces Presentations at the 2020 Society for Immunotherapy of Cancer Annual Meeting - GlobeNewswire

Global Stem Cell Therapy Market 2020: Trends, and Opportunity Analysis, Top Manufacturers And Forecast to 2027 – PRnews Leader

Reportspedia has recently come up with a new market research report titled, Stem Cell Therapy Market. This statistical market study compromises an extensive understanding of the present-day and impending stages of the industry market based on factors such as major research skills, management schemes, drivers, restraints, opportunities, challenges, and visions include the subdivisions in the industries and regional distribution. Besides, this report emphasizes the latest events such as technological developments and product launches and their consequences on the Market. The research report delivers the global market revenue, parent market trends along with market attractiveness per market segment.

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Global Stem Cell Therapy Market 2020: Trends, and Opportunity Analysis, Top Manufacturers And Forecast to 2027 - PRnews Leader

Cytovia Therapeutics partners with Inserm to develop selective CD38 NK therapeutics and offer new treatment options for Multiple Myeloma patients |…

Details Category: DNA RNA and Cells Published on Thursday, 08 October 2020 15:15 Hits: 194

NEW YORK, NY, USA and PARIS, France I October 08, 2020 I Cytovia Therapeutics ("Cytovia"), an emerging biopharmaceutical company, announces today that it has entered a research and licensing agreement with Inserm to develop NK engager bi-specific antibodies and iPSC CAR NK cell therapy targeting CD38, a key marker of multiple myeloma. The licensing agreement has been negotiated and signed by Inserm Transfert, the private subsidiary of Inserm, on behalf of Inserm (the French National Institute of Health and Medical Research) and its academic partners. Cytovia is licensing Inserm's CD38 antibody and Chimeric Antigen Receptor (CAR) patent and applying its proprietary NK engager bispecific antibody and iPSC CAR NK technology platforms. The research agreement will include evaluation of the therapeutic candidates at Hpital Saint-Louis Research Institute (Inserm Unit 976) under the leadership of Professors Armand Bensussan and Jean-Christophe Bories.

Dr Daniel Teper, Cytovia's Chairman and CEO commented: "We are delighted to partner with one of the top centers of excellence in the world for research and treatment in hematology. CD38 is a validated target and Natural Killer cells have significant cytotoxicity to Myeloma cells. We are looking forward to bringing promising new options to address the unmet needs of patients with Multiple Myeloma and aim for a cure."

Professor Armand Bensussan, Director of The Immuno-Oncology Research Institute at Hpital Saint-Louis added: "We have demonstrated the selectivity of our novel CD38 antibody in killing myeloma cells but not normal cells such as NK, T, and B cells. The activation of NK cells through NKp46 may enhance the efficacy of the bispecific antibody in patients not responsive to CD38 monoclonal antibody therapy. CD38 CAR NK is a promising approach forrelapsed/refractory patients and an alternative to CAR T therapies."

About Multiple Myeloma Multiple Myeloma is a currently incurable cancer, affecting a type of white blood cell known as plasma cells. It leads to an accumulation of tumor cells in the bone marrow, rapidly outnumbering healthy blood cells. Instead of producing beneficial antibodies, cancerous cells release abnormal proteins causing several complications. While symptoms are not always present, the majority of patients are diagnosed due to symptoms such as bone pain or fracture, low red blood cell counts, fatigue, high calcium levels, kidney problems, and infections. According to the World Cancer Research Fund, Multiple Myeloma is the second most common blood cancer, with nearly 160,000 new annual cases worldwide, including close to 50,000 in Europe. 32,000 in the US, and 30,000 in Eastern Asia. Over 95% of cases are diagnosed late, with a 5-year survival rate of 51%. Initial treatment comprises of a combination of different therapies, including biological and targeted therapies, corticosteroids, and chemotherapy, with the option for bone marrow transplants for eligible patients. Immunotherapy and cell therapy are the most promising new treatment option for Multiple Myeloma, with the potential for long term cancer remission.

About CAR NK cells Chimeric Antigen Receptors (CAR) are fusion proteins that combine an extracellular antigen recognition domain with an intracellular co-stimulatory signaling domain. Natural Killer (NK) cells are modified genetically to allow insertion of a CAR. CAR-NK cell therapy has demonstrated initial clinical relevance without the limitations of CAR-T, such as Cytokine Release Syndrome, neurotoxicity or Graft vs Host Disease (GVHD). Induced Pluripotent Stem Cells (iPSC) - derived CAR-NKs are naturally allogeneic, available off-the-shelf and may be able to be administered on an outpatient basis. Recent innovative developments with the iPSC, an innovative technology, allow large quantities of homogeneous genetically modified CAR NK cells to be produced from a master cell bank, and thus hold promise to expand access to cell therapy for many patients.

About Cytovia Cytovia Therapeutics Inc is an emerging biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem, and CytoImmune Therapeutics. Learn more at http://www.cytoviatx.com

About Inserm Founded in 1964, the French National Institute of Health and Medical Research (Inserm) is a public science and technology institute, jointly supervised by the French Ministry of National Education, Higher Education and Research, and the Ministry of Social Affairs, Health and Womens Rights. Inserm is the only French public research institute to focus entirely on human health and position itself on the pathway from the research laboratory to the patients bedside. The mission of its scientists is to study all diseases, from the most common to the rarest. With an initial 2020 budget of 927.28 million, Inserm supports nearly 350 laboratories throughout France, with a team of nearly 14,000 researchers, engineers, technicians, and post-doctoral students. http://www.inserm.fr

SOURCE: Cytovia Therapeutics

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Cytovia Therapeutics partners with Inserm to develop selective CD38 NK therapeutics and offer new treatment options for Multiple Myeloma patients |...

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.

Link:
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.

The report assesses the important factors and aspects that are crucial to the client to post good growth in revenue as well as business expansion. Some of these aspects are sales, revenue, market size, mergers and acquisitions, risks, demands, new trends and technologies and much more are taken into consideration to give a complete and detailed understanding of the market conditions. Coupled with your expertise this report can make you a big player in the Induced Pluripotent Stem Cells Market and can get you in the frontrunners of the Induced Pluripotent Stem Cells Market.

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This report has concise and apt data on the Induced Pluripotent Stem Cells market which is updated as the international markets change. The past few years the markets have changed drastically and its becoming harder to get a grasp of and hence our analysts here at Reports Intellect have prepared a detailed report while taking in consideration the market issues and their solution to give you the best information and leverage on your competition.

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Induced Pluripotent Stem Cells Market Type Coverage:

Human iPSCs Mouse iPSCs

Induced Pluripotent Stem Cells Market Application Coverage:

Academic Research Drug Development and Discovery Toxicity Screening Regenerative Medicine

Market Segment by Regions and Nations included:

North America (United States, Canada, Mexico)

Asia-Pacific (China, Japan, Korea, India, Southeast Asia)

South America (Brazil, Argentina, Colombia, etc.)

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.

To identify significant trends, drivers, influence factors in global and regions

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the Stem Cell-Derived Cells market.

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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