Category Archives: Induced Pluripotent Stem Cells


Multiple gene edits and computer simulations could help treat rare genetic diseases – University of Wisconsin-Madison

The lab of KrisSaha at the University of WisconsinMadison has developed an innovative combination of gene-editing tools and computational simulations that can be used to develop new strategies for editing genes associated with genetic disorders.

In proof-of-concept experiments, the labs researchers efficiently corrected multiple mutations responsible for a rare metabolic disorder, known as Pompe disease, in cells containing the disease-causing errors. They also used computer simulations to design the ideal gene-editing approach for treating human patients, a boon for rare disorders like Pompe disease that lack useful animal models.

Their promising platform advances the CRISPR genome-editing field and could lead to effective treatments for many diseases, not just Pompe disease.

The exact mutations seen in the Pompe patients are not in an existing animal model, so we cannot do all of the preclinical studies that we would like to do in order to evaluate the safety and efficacy of different genome editing strategies, says Saha, a professor of biomedical engineering at UWMadisons Wisconsin Institute for Discovery. We need a way to think about how we go from patient material to a therapy without having to build an animal model, a process that takes months to years and hundreds of thousands of dollars.

The lab of Kris Saha (standing) has developed an innovative combination of gene-editing tools and computational simulations that can be used to develop new strategies for editing genes associated with genetic disorders. Photo: Stephanie Precourt

Sahas team published its findings Dec. 8 in the journal Nature Communications.

In the first few months of life, an infant with Pompe disease becomes weaker and weaker as glycogen builds up in their muscles, their cells unable to break the complex sugar down. Multiple mutations in a gene calledGAAprevent their cells from correctly producing the proteins needed to make lysosomes, which turn glycogen into glucose, the fuel that powers cells. Left untreated, most patients with Pompe die within a year.

Developing effective therapies for such diseases can be difficult for a number of reasons. First, diseases like Pompe have no animal models in which to test treatments, a typical step in therapy development. And diseases like Pompe and many other inherited diseases are autosomal recessive, which means that mutations are present on both copies of a chromosome. Two sets of mutations require two successful gene-repair events for maximum effect. Further complicating the matter is the fact that many diseases are polygenic, resulting from mutations in two or more genes or multiple mutations spread across a single gene, as is the case for Pompe disease.

The Saha labs new approach uses precise gene-editing tools to edit both faulty alleles simultaneously within individual cells to restore function. In its new report, the research team used induced pluripotent stem cells derived from Pompe patients to reproduce the exactGAAmutations that cause the disease and to approximate the resulting tissue pathology.

To fix these Pompe mutations, the lab turned to a specially designed, ultra-precise genome-editing system described in aprevious studyled by Jared Carlson-Stevermer, who was at the time a graduate student in Sahas group. That report established an up to 18-fold increase in precision of gene edits by combining a DNA repair template with the cutting machinery of CRISPR in one particle.

In the current study, the researchers used the method to fix two mutations at once in Pompe-derived cells. By doing so, the researchers improved cell function dramatically, bringing lysosome protein production up to the level of healthy cells without any major adverse effects, which sometimes emerge from gene editing.

The research advances the CRISPR genome-editing field and could lead to effective treatments for many diseases.

But treating cells in the laboratory, while providing crucial insight, is not the same as creating a therapy for patients. A critical step in developing treatments usually involves testing on animal models to evaluate efficacy and safety, a major obstacle for Pompe disease and other genetic conditions that lack viable animal models.

To determine the best therapeutic strategy for polygenic diseases evaluating different doses, delivery mechanisms and timing, risks and other factors the research team instead built a computational model that allows it to predict the outcomes of various conditions.

This allows us to survey a wider scope of many different gene therapies during the design of a strategy, says coauthor Amritava Das, a postdoctoral associate at the Morgridge Institute for Research. The computational approach is critical when you dont have an animal model that resembles the human disease.

After pumping close to a million simulation conditions through the computational model, Das, Carlson-Stevermer and Saha have gained key insights about the delivery of gene editors into the livers of human infants with Pompe disease without having to subject a single patient to experimental treatments. And those insights establish that the multiple-correction genome-editing approach tested in stem cells may be an effective treatment for Pompe and other polygenic recessive disorders.

The computational model, which can be easily adapted for other polygenic conditions, is a big step for the development of therapies for diseases like Pompe and lays the groundwork for a bridge from laboratory studies to the clinic. And as more measurements are added to the model, it will gain more predictive power.

Its a very broad, adaptable platform, Das says about the combined stem cell model and computational tool, and a very different way of thinking about gene therapy.

This work was supported by the National Science Foundation (CBET-1350178, CBET-1645123), the National Institutes of Health (1R35GM119644-01), the Environmental Protection Agency (EPA-G2013 STAR-L1), the University of Wisconsin Carbone Cancer Center (P30 CA014520), the Wisconsin Alumni Research Foundation, and the Wisconsin Institute for Discovery.

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Multiple gene edits and computer simulations could help treat rare genetic diseases - University of Wisconsin-Madison

Cytovia Therapeutics announces plans to initiate in 2021 Clinical Development of Universal iPSC NK Cell Therapy for Hematological and Solid Tumors -…

December 08, 2020 09:04 ET | Source: Cytovia Therapeutics

CAMBRIDGE, Mass., Dec. 08, 2020 (GLOBE NEWSWIRE) -- Cytovia Therapeutics, an emerging NK cell therapeutics company, announced today that it plans to file with the FDAin 2021an Investigational New Drug (IND) application and initiate clinical trials in hematological and solid tumors with its Universal iPSC NK cell therapy (U-iNK).

Cytovia's CEO, Dr. Daniel Teper commented: "Cytovia is among a select group of biotech companies developing Gene Edited iPSC NK and CAR NK cell therapeutics. We are aiming to be, in 2021, the second company to initiate clinical trials with an iPSC NK product. We are enthusiastic about the potential of U-iNK to prevent relapse in Acute Myeloid Leukemia, and in combination with PD1/ PDL-1 inhibitors and our own NK engager bispecific antibodies, to improve outcomes in solid tumors starting with hepatocellular carcinoma."

Cytovia will participate in the RBC Capital Markets Healthcare Private Company Conference on December 15-16, 2020. Daniel Teper, PharmD, CEO, Wei Li, PhD, CSO and Kaouthar Lbiati, MD, VP, Product Strategy will take part in a Fireside chat with RBC's Senior Analyst, Gregory Renza, MD, on December 16, 2020 at 10am ET. A link to the discussion will be available on Cytovias website and social media channels.

About Cytovia TherapeuticsCytovia 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. 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, INSERM, and CytoImmune Therapeutics.

Learn more atwww.cytoviatx.comand follow Cytovia Therapeutics on Social MediaFacebook,LinkedIn,Twitter, Youtube

For more information, please contact:

Cytovia Therapeutics, Inc SophieBadr Vice President, Corporate Affairs sophie.badre@cytoviatx.com Cell: 1 (929) 317 1565

Anna Baran-Djokovic Vice President, Investor Relations anna@cytoviatx.com VP Investor Relations Cell: +44 7521083006

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Cytovia Therapeutics announces plans to initiate in 2021 Clinical Development of Universal iPSC NK Cell Therapy for Hematological and Solid Tumors -...

Fate Therapeutics Reports Positive Interim Data from its Phase 1 Study of FT516 in Combination with Rituximab for B-cell Lymphoma – GlobeNewswire

December 04, 2020 16:01 ET | Source: Fate Therapeutics, Inc.

3 of 4 Patients Evaluable for Efficacy in Dose Escalation Cohorts 2 and 3 Show Objective Response, with 2 Patients Achieving Complete Response

No Observed Events of Any Grade of Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, or Graft-vs-Host Disease

Six Doses of FT516 were Well-tolerated with No FT516-related Grade 3 or Greater Adverse Events Reported by Investigators

Management to Host Virtual Event Entitled The Power of hnCD16 Today at 4:30 PM Eastern Time

SAN DIEGO, Dec. 04, 2020 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced positive interim data from the Companys dose escalation Phase 1 study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma. FT516 is the Companys universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.

We are highly encouraged by these Phase 1 data, which clearly demonstrate that off-the-shelf, iPSC-derived NK cells can drive complete responses for cancer patients and that our proprietary hnCD16 Fc receptor can effectively synergize with and enhance the mechanism of action of tumor-targeted antibodies, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. Importantly, the safety profile of FT516 continues to suggest multiple doses of iPSC-derived NK cells can be administered in the outpatient setting, and supports potential use across multiple lines of therapy, including as part of early-line CD20-targeted monoclonal antibody regimens, for the treatment of B-cell lymphoma.

As of a November 16, 2020 data cutoff, three patients in the second dose cohort of 90 million cells per dose and one patient in the third dose cohort of 300 million cells per dose were available for assessment of safety and efficacy. All four patients were heavily pre-treated, having received at least two prior rituximab-containing regimens. Each patient received two 30-day treatment cycles, with each cycle consisting of fludarabine and cyclophosphamide lympho-conditioning followed by three once-weekly doses of FT516, IL-2 cytokine support, and rituximab.

Safety Data All four relapsed / refractory patients were administered FT516 in an outpatient setting with no requirement for inpatient monitoring. No dose-limiting toxicities, and no cases of any grade of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease, were observed. The multi-dose, two-cycle treatment regimen was well-tolerated with no FT516-related grade 3 or greater adverse events reported by investigators. In addition, no evidence of anti-product T- or B-cell mediated host-versus-product alloreactivity was detected, supporting the potential to safely administer up to six doses of FT516 in the outpatient setting without patient matching. All grade 3 or greater treatment emergent adverse events were not related to FT516 and were consistent with lympho-conditioning chemotherapy and underlying disease.

Activity Data Three of four relapsed / refractory patients achieved an objective response, including two complete responses (CR), following the second FT516 treatment cycle as assessed by PET-CT scan per Lugano 2014 criteria. A CR was achieved in one patient with diffuse large B-cell lymphoma (DLBCL) who was most recently refractory to a rituximab-containing treatment regimen, and a CR was achieved in one patient with follicular lymphoma (FL) who had previously been treated with four rituximab-containing treatment regimens. Notably, in one patient for which an interim tumor assessment showed a partial response following the first FT516 treatment cycle, the response deepened to a CR following administration of the second FT516 treatment cycle, suggesting that additional FT516 treatment cycles can confer clinical benefit.

M = million; CR = Complete Response; PR = Partial Response; PD = Progressive Disease As of November 16, 2020 database entry. Data subject to cleaning and source document verification. 1 Day 29 of the second FT516 treatment cycle as assessed per Lugano 2014 criteria

Dose escalation is continuing in the current dose cohort of 300 million cells per dose in combination with rituximab, and a fourth dose cohort of 900 million cells per dose in combination with rituximab is planned. The Company previously reported that two patients treated in the first dose cohort of 30 million cells per dose in combination with rituximab showed a protocol-defined response assessment of progressive disease. No events of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease were observed in either patient.

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 FT516 FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Scientists from the Company have shown in a peer-reviewed publication (Blood. 2020;135(6):399-410) that hnCD16 iPSC-derived NK cells, compared to peripheral blood NK cells, elicit a more durable anti-tumor response and extend survival in combination with anti-CD20 monoclonal antibodies in an in vivo xenograft mouse model of human lymphoma. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in an open-label, multi-dose Phase 1 clinical trial as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of advanced B-cell lymphoma (NCT04023071). Additionally, FT516 is being investigated in an open-label, multi-dose Phase 1 clinical trial in combination with avelumab for the treatment of advanced solid tumor resistant to anti-PDL1 checkpoint inhibitor therapy (NCT04551885).

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 safety and therapeutic potential of the Companys iPSC-derived NK cell product candidates, including FT516, its ongoing and planned clinical studies, and the expected clinical development plans for FT516. 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 that results observed in studies of its product candidates, including preclinical studies and clinical trials of any of its product candidates, will not be observed in ongoing or future studies involving these product candidates, the risk that the Company may cease or delay 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 or delays in subject enrollment in current and planned clinical trials, 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), and the risk that its 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.

Contact: Christina Tartaglia Stern Investor Relations, Inc. 212.362.1200 christina@sternir.com

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Fate Therapeutics Reports Positive Interim Data from its Phase 1 Study of FT516 in Combination with Rituximab for B-cell Lymphoma - GlobeNewswire

Constantly Growing Applications and Innovations to Push Sales of Amniotic Membrane Market Up To ~US$2.4 Bn by 2027, Observes TMR – PRNewswire

ALBANY, N.Y, Dec. 8, 2020 /PRNewswire/ -- Transparency Market Research has published a new research report that provides detailed information about the global amniotic membrane market. The research report tried to shed light on different growth factors, prominent growth challenges, key segments, geographical outlook, and vendor landscape of the global amniotic membrane market. According to the research report, the amniotic membrane market is projected to reach a valuation worth US$2.4 Bn by the end of 2027. Initially, the valuation of the global market was around US$980 Mn, in 2018. In order to achieve such huge surge in terms of revenue, the market is projected to showcase a massive CAGR of ~10% over the course of the given period of assessment ranging from 2019 to 2027.

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Constantly Growing Applications and Innovations to Push Sales of Amniotic Membrane Market Up To ~US$2.4 Bn by 2027, Observes TMR - PRNewswire

Tulane researcher shows enhanced therapeutic stem cell migration improves neurodegenerative disease – News from Tulane

Jean-Pyo Lee, PhD, assistant professor in the Department of Physiology at Tulane School of Medicine, in collaboration with colleagues at Sanford Burnham Prebys Medical Discovery Institute and the University of California San Diego, has shown for the first time that injection of a synthetic drug that attracts stem cell migration can improve neurological outcome in a mouse model of neurodegenerative disease. (Photo provided)

Stem cell therapy, especially neural stem cells, offers great promise in treating brain injury. Neural stem cells exhibit a broad repertoire of potentially multiple therapeutic actions including functional neural replacement and acute and chronic anti-inflammatory action via the delivery of therapeutic gene products synthesized inherently by the stem cells in the disease environment.

For optimal stem cell therapy, neural stem cells should migrate quickly and extensively to the site of injury and neurodegeneration.

Jean-Pyo Lee, PhD, assistant professor in the Department of Physiology at Tulane School of Medicine, in collaboration with colleagues at Sanford Burnham Prebys Medical Discovery Institute and the University of California San Diego, has shown for the first time that injection of a synthetic agonist (drug),that attracts stem cell migration can improve neurological outcome in a mouse model of neurodegenerative disease. The research was recently published by the Proceedings of the National Academy of Sciences of the United States of America and can be viewed here: https://www.pnas.org/content/early/2020/11/19/1911444117.

The study addresses the important nature of tropism of stem cell migration using neural stem cells, Lee said. Chemokines and chemokine receptors found inneural stem cells can mediate this activity.

In this study, human neural stem cells derived from induced pluripotent stem cells were used. Transplantation of human induced pluripotent stem cell-derived neural stem cells in a mouse model of a prototypical neurodegenerative disease improves neurological function and increases the life span of neurodegenerative mice.

The study also found that a synthetic chemokineanalog attracts these neural stem cellsand increases the beneficial impact of these stem cells on neurological disorders, Lee said. When this analog is co-administered with transplanted neural stem cells, the agonist (drug) enhanced stem cell migration, dissemination and integration into the diseased brains. Considering the prevalence of neurological diseases and current limitations of stem cell therapy, the findings will contribute to advancing the stem cell field and will be of great interest to further neurodegenerative disease research.

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Tulane researcher shows enhanced therapeutic stem cell migration improves neurodegenerative disease - News from Tulane

Researchers restore lost sight in mice, offering clues to reversing aging – Science Magazine

Researchers reversed damage to the mouse eye (shown in a microscope image of a healthy animal, above) by genetically reprogramming neurons that make up the optic nerve.

By Kelly ServickDec. 2, 2020 , 5:30 PM

Do old and damaged cells remember what it was like to be young? Thats the suggestion of new study, in which scientists reprogrammed neurons in mouse eyes to make them more resistant to damage and able to regrow after injurylike the cells of younger mice. The study suggests that hallmarks of aging, and possibly the keys to reversing it, lie in the epigenome, the proteins and other compounds that decorate DNA and influence what genes are turned on or off.

The idea that aging cells hold a memory of their young epigenome is very provocative, says Maximina Yun, a regenerative biologist at the Dresden University of Technology who was not involved in the work. The new study supports that [idea], but by no means proves it, she adds. If researchers can replicate these results in other animals and explain their mechanism, she says, the work could lead to treatments in humans for age-related disease in the eye and beyond.

Epigenetic factors influence our metabolism, our susceptibility to various diseases, and even the way emotional trauma is passed through generations. Molecular biologist David Sinclair of Harvard Medical School, who has long been on the hunt for antiaging strategies, has also looked for signs of aging in the epigenome.

The big question was, is there a reset button? he says. Would cells know how to become younger and healthier?

In the new study, Sinclair and his collaborators aimed to rejuvenate cells by inserting genes that encode reprogramming factors,which regulate gene expressionthe reading of DNA to make proteins. The team chose three of the four factors scientists have used for more than 10 years to turn adult cells into induced pluripotent stem cells, which resemble the cells of an early embryo. (Exposing animals to all four factors can cause tumors.)

The team focused specifically on neurons at the back of the eye called retinal ganglion cells. These cells relay information from light-sensitive photoreceptors to the brain using long tendrillike structures called axons, which make up the optic nerve. Theres a stark divide between youth and age in these cells: An embryonic or newborn mouse can regenerate the optic nerve if it gets severed, but that ability vanishes with time.

To test whether their treatment could bring back some of that resilience, Sinclair and colleagues crushed the optic nerves of mice using forceps and injected a harmless virus into the eye carrying the genes for the three reprogramming factors. The injection prevented some damaged retinal ganglion cells from dying and even prompted some to grow new axons reaching back to the brain, the team reports today in Nature.

When the researchers looked at methylation patternsthe DNA location of chemical tags called methyl groups that regulate gene expressionthey found that changes caused by the injury resembled those in aging mouse cells. In certain parts of the genome, the treatment reversed those changes. The researchers also found that the benefits of the introduced genes depended on cells ability to alter their methylation patterns: Mice lacking certain enzymes necessary to remove methyl groups from DNA saw no benefit to the treatment.

Thats really something special, says Leonard Levin, a visual neuroscientist at McGill University. The experiments suggest how the famous and well-studied reprogramming factors restore cells. But big questions remain, he says: How do these factors cause methyl groups to be added or removed? How does that process help retinal ganglion cells?

Sinclairs team also tested the approach in mice with a condition meant to mimic glaucoma, a leading cause of age-related blindness in humans. In glaucoma, the optic nerve gets damaged, often by a buildup of pressure in the eye. Sinclair and his colleagues injected tiny beads into the animals eyes that prevented normal drainage and increased pressure, which damaged retinal ganglion cells.

Four weeks later, the animals visual acuity had declined by about 25%, as measured by a vision test in which mice move their heads to track the movement of vertical bars displayed on computer monitors. But after the genetic treatment, the animals gained back roughly half of their lost acuitythe first demonstration of restored vision in mice after this glaucomalike injury.

Still, the improvement in acuity was small, Levin notes. And, he says, the treated mice were in a relatively early stage of damage, not the state of near or total blindness that people experience when glaucoma goes untreated for years. So its too early to say whether this approach could benefit people who have lost much of their vision. Levin adds that there are already very good treatments for early-stage glaucoma to prevent vision loss with medicated eye drops or surgery to lower eye pressure.

In a final set of experiments, Sinclair and colleagues injected the reprogramming-factor genes into the eyes of 1-year-old healthy mice, roughly the mouse equivalent of middle-age. By this stage, the animals had visual acuity scores about 15% lower than their 5-month-old counterparts. Four weeks after treatment, older mice had similar acuity scores to younger ones. In their cells, the researchers saw patterns of DNA methylation and gene expression resembling those of younger animals.

In the three sets of experiments, Sinclair says, the cells seemed to respond to the reprogramming factors by fine-tuning their gene expression to match a youthful state. He sees that behavior as a hint that cells keep a record of their epigenetic past, even though its not clear how that record is stored. A company Sinclair cofounded, Life Biosciences, is developing treatments for diseases associated with aging, including glaucoma, and he says hes now planning to test the safety of this gene therapy approach in larger animals.

Yun says that as a strategy for reversing aging or treating disease, resetting the epigenome is a very difficult one. Reprogramming cells to an earlier state carries a risk of prompting uncontrolled growth and cancer.Future studies should test how the three factors affect other types of cells and tissues and confirm that reprogrammed cells maintain their youthful state long-term, she says. There are a lot of roads to be traveled.

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Researchers restore lost sight in mice, offering clues to reversing aging - Science Magazine

Fate Therapeutics Reports Positive Interim Data from its Phase 1 Study of FT516 in Combination with Rituximab for B-cell Lymphoma | DNA RNA and Cells…

Details Category: DNA RNA and Cells Published on Monday, 07 December 2020 09:38 Hits: 377

3 of 4 Patients Evaluable for Efficacy in Dose Escalation Cohorts 2 and 3 Show Objective Response, with 2 Patients Achieving Complete Response

No Observed Events of Any Grade of Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, or Graft-vs-Host Disease

Six Doses of FT516 were Well-tolerated with No FT516-related Grade 3 or Greater Adverse Events Reported by Investigators

SAN DIEGO, CA, USA I December 04, 2020 I Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced positive interim data from the Companys dose escalation Phase 1 study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma. FT516 is the Companys universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.

We are highly encouraged by these Phase 1 data, which clearly demonstrate that off-the-shelf, iPSC-derived NK cells can drive complete responses for cancer patients and that our proprietary hnCD16 Fc receptor can effectively synergize with and enhance the mechanism of action of tumor-targeted antibodies, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. Importantly, the safety profile of FT516 continues to suggest multiple doses of iPSC-derived NK cells can be administered in the outpatient setting, and supports potential use across multiple lines of therapy, including as part of early-line CD20-targeted monoclonal antibody regimens, for the treatment of B-cell lymphoma.

As of a November 16, 2020 data cutoff, three patients in the second dose cohort of 90 million cells per dose and one patient in the third dose cohort of 300 million cells per dose were available for assessment of safety and efficacy. All four patients were heavily pre-treated, having received at least two prior rituximab-containing regimens. Each patient received two 30-day treatment cycles, with each cycle consisting of fludarabine and cyclophosphamide lympho-conditioning followed by three once-weekly doses of FT516, IL-2 cytokine support, and rituximab.

Safety Data All four relapsed / refractory patients were administered FT516 in an outpatient setting with no requirement for inpatient monitoring. No dose-limiting toxicities, and no cases of any grade of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease, were observed. The multi-dose, two-cycle treatment regimen was well-tolerated with no FT516-related grade 3 or greater adverse events reported by investigators. In addition, no evidence of anti-product T- or B-cell mediated host-versus-product alloreactivity was detected, supporting the potential to safely administer up to six doses of FT516 in the outpatient setting without patient matching. All grade 3 or greater treatment emergent adverse events were not related to FT516 and were consistent with lympho-conditioning chemotherapy and underlying disease.

Activity Data Three of four relapsed / refractory patients achieved an objective response, including two complete responses (CR), following the second FT516 treatment cycle as assessed by PET-CT scan per Lugano 2014 criteria. A CR was achieved in one patient with diffuse large B-cell lymphoma (DLBCL) who was most recently refractory to a rituximab-containing treatment regimen, and a CR was achieved in one patient with follicular lymphoma (FL) who had previously been treated with four rituximab-containing treatment regimens. Notably, in one patient for which an interim tumor assessment showed a partial response following the first FT516 treatment cycle, the response deepened to a CR following administration of the second FT516 treatment cycle, suggesting that additional FT516 treatment cycles can confer clinical benefit.

M = million; CR = Complete Response; PR = Partial Response; PD = Progressive Disease As of November 16, 2020 database entry. Data subject to cleaning and source document verification. 1 Day 29 of the second FT516 treatment cycle as assessed per Lugano 2014 criteria

Dose escalation is continuing in the current dose cohort of 300 million cells per dose in combination with rituximab, and a fourth dose cohort of 900 million cells per dose in combination with rituximab is planned. The Company previously reported that two patients treated in the first dose cohort of 30 million cells per dose in combination with rituximab showed a protocol-defined response assessment of progressive disease. No events of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease were observed in either patient.

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 FT516 FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Scientists from the Company have shown in a peer-reviewed publication (Blood. 2020;135(6):399-410) that hnCD16 iPSC-derived NK cells, compared to peripheral blood NK cells, elicit a more durable anti-tumor response and extend survival in combination with anti-CD20 monoclonal antibodies in an in vivo xenograft mouse model of human lymphoma. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in an open-label, multi-dose Phase 1 clinical trial as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of advanced B-cell lymphoma (NCT04023071). Additionally, FT516 is being investigated in an open-label, multi-dose Phase 1 clinical trial in combination with avelumab for the treatment of advanced solid tumor resistant to anti-PDL1 checkpoint inhibitor therapy (NCT04551885).

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.

SOURCE: Fate Therapeutics

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Fate Therapeutics Reports Positive Interim Data from its Phase 1 Study of FT516 in Combination with Rituximab for B-cell Lymphoma | DNA RNA and Cells...

Bayer and Atara Biotherapeutics in CAR T-cell therapy deal – BioPharma-Reporter.com

Atara is a pioneer in allogeneic T-cell immunotherapy with industry-leading allogeneic cell manufacturing processes and CAR T technologies.

Under the terms of the deal, that San Francisco-based innovator will receive an upfront payment of US60m, and up to a total of US$610m for development, regulatory and commercialization milestones, plus tiered royalties up to low double-digit percentage of net sales.

The collaboration will focus on Ataras off-the-shelf allogeneic T-cell immunotherapy, ATA3271, for high mesothelin-expressing tumors, and its autologous version, ATA2271, for high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer.Both therapies were developed in conjunction with Memorial Sloan Kettering Cancer Center (MSK).

Mesothelin is a tumor-specific antigen that is commonly expressed at high levels on the cell surface in many aggressive solid tumors and is an attractive target for immune-based therapies, including CAR T therapy.

Both ATA2271 and ATA3271 are engineered for use in solid tumors as they incorporate Ataras novel inclusion of both a PD-1 DNR construct to overcome checkpoint inhibition and a 1XX costimulatory domain on the CAR (chimeric antigen receptor) to enhance expansion and functional persistence of the CAR T cells.

ATA3271, the allogeneic version of this CAR T, leverages Ataras EBV T-cell platform and is currently in IND-enabling studies. ATA2271, the autologous version, has enrolled the first patient in an open-label, single-arm Phase 1 clinical study in November 2020.

Bayer said the deal is a fundamental element of its new cell and gene therapy strategy. It strengthens our development portfolio through allogeneic cell therapies and consolidates our emerging leadership in the field, said Wolfram Carius, head of the pharma giants CGT unit.

We look forward to collaborating with Atara to develop off-the-shelf CAR T-cell therapies for patients with difficult-to-treat cancers, he added.

Pascal Touchon, CEO of Atara, said Bayers proven track record in oncology global development and commercialization, and growing presence in cell and gene therapy, enhances Ataras capabilities and complements its leading allogeneic T-cell platform.

Atara is to lead the Investigational New Drug (IND)-enabling studies and process development for ATA3271 while Bayer will be responsible for submitting the IND and subsequent clinical development and commercialization. Atara will also continue to be responsible for the ongoing ATA2271 phase 1 study, for which an IND filing has been accepted and the clinical trial initiated.

As part of the deal, Atara will also provide translational and clinical manufacturing services to be reimbursed by Bayer. In addition, for a limited period of time, Bayer has a non-exclusive right to negotiate a license for additional Atara CAR T product candidates.

In order to build up its presence in the CGT sphere, Bayer said it is focused on strengthening its internal capabilities in that respect.

In parallel, it says it is pursuing external strategic collaborations, technology acquisitions and licensing. The goal is to build robust platforms with broad application across different therapeutic areas.

It outlined selected areas of CGT for its strategic focus including stem cell therapies with an emphasis on induced pluripotent cells or iPSCs - gene augmentation, gene editing and allogeneic cell therapies in different indications.

Leveraging external innovation together with the expertise of the teams at Bayer represents a key value-driver, especially in the highly dynamic and competitive field of CGT. Bayers operating model for CGT, where partners operate autonomously and are fully accountable to develop and progress their portfolio and technology, is essential for preserving their entrepreneurial culture and positions Bayer as a partner of choice.

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Repairing the Brain With Stem Cells? A Conversation With Prof. Jack Price – Being Patient

Groundbreaking research in stem cells has propelled scientists understanding of neurodegenerative diseases, including Parksinsons. Could stem cell therapies one day help cure Alzheimers?

Clinical trials of stem cell therapies are now underway to repair the damaged cells of people with Parkinsons disease and age-related macular degeneration. Being Patient spoke with Jack Price, professor of developmental neurobiology at Kings College London and author of the book The Future of Brain Repair, about the potential and challenges of repairing the brain with stem cell therapy.

Being Patient: What is stem cell therapy?

Prof. Jack Price: Its the transplantation of stem cells, either directly into the brain or in a way that gives them access to the brain and influence the brain, to bring about a therapeutic effect.

Being Patient: Are there stem cells in the brain?

Prof. Jack Price: For many years, neuroscientists didnt think there were stem cells in the brain. We now know there are. We know about a population [of stem cells] thats become very important in our understanding of Alzheimers disease and in mood disorders like anxiety and depression. These are stem cells that are found in a part of the brain called the hippocampus.

But by and large, the brain doesnt have stem cells, unlike skin and other tissues in the body. The blood is the classic [example]: Theres a population of stem cells in the bone marrow that regenerates blood all the time.

Being Patient: What makes stem cells so special and why are they a focus of research?

Prof. Jack Price: The definition of stem cells is a population of cells that gives rise to other types of cells. In neural stem cells, precursor cells can make adult brain cells, nerve cells, glial cells, all the different cell types that make up the brain. If you have a disease like Alzheimers or any other neurodegenerative disease, where we know the key pathology is the loss of nerve cells, your brain doesnt normally have the ability to replace those lost brain cells. The idea was [that] if you put stem cells where the loss of brain cells has taken place, maybe those stem cells would replace the lost cells.

Being Patient: What is the potential of stem cell therapy in treating neurodegenerative diseases?

Prof. Jack Price: Theres a piece of absolutely brilliant stem cell science that was done by Shinya Yamanaka in Kyoto in 2006. He showed you could effectively take any cell through a very straightforward genetic manipulation that he discovered, [and] turn them into what we call pluripotent stem cells, which are cells that can make any cell type in the body. They also have an ability that other stem cells generally dont: They can build tissue. If you grow them in a little culture dish, they can start to make little pieces of brain called organoids or cerebroids. This was a groundbreaking technology.

In Parkinsons disease, theres enormous progress and clinical trials are underway now. We know more about the pathology of Parkinsons disease [than in Alzheimers]. The pathology of Alzheimers turns out to be quite complex, and weve had, over the years, quite a few ideas about how it worked. But [turning] those into actual therapies hasnt quite worked as we expected, and we keep having to go back and rethink whats going on in Alzheimers.

The pathology of Parkinsons disease is also difficult. Its not trivial. But at the same time, one thing is clear: a lot of the pathology is associated with the loss of a particular population of nerve cells the midbrain dopaminergic cells. We can start with these pluripotent stem cells and make them make precisely the right type of dopaminergic cell that we know is lost in Parkinsons disease.

This is built on 30 [to] 40 years of research of people trying to find exactly the right cell type to work [with] in Parkinsons disease. They had some early success and fell backwards. But this technology looks much more precise than everything anybodys ever tried before.

In age-related macular degeneration, the disease of the eye where you lose your retinal photoreceptors, there are very clever strategies now where people are using these pluripotent stem cells to make a thing called a retinal pigment epithelium. It lies behind the retina, but its what supports the photoreceptors. It turns out, thats what goes wrong in age-related macular degeneration.

Being Patient: Are there any stem cell therapy approved to treat brain disorders?

Prof. Jack Price: There are no licensed stem cell therapy for any brain disorders anywhere in the world for the simple reason [that] nobody has shown one works. There are a lot of stem cell clinics in the U.S. and somewhat fewer elsewhere who are offering cell therapies that are untested. Theyll put stem cells into you for any disorder youve got. Those cell therapies do not work.

A lot of genuine companies are trying to get these cell therapies to work in clinical trials and falling flat on their face quite often, despite their best efforts. 90% of clinical trials fail, and thats clinical trials of conventional drugs by drug companies that know what theyre doing.

What do you suppose is the chance with a stem cell therapy [that] we dont really understand how it works, [that] we dont quite know how to manufacture it properly, [and that] we dont quite know what cells we really want, of working? The chance is almost zero. These companies know that, which is why theyre not going to clinical trials.

The interview has been edited for length and clarity.

Contact Nicholas Chan at nicholas@beingpatient.com

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Repairing the Brain With Stem Cells? A Conversation With Prof. Jack Price - Being Patient

Global Induced Pluripotent Stem Cells Market Size, Comprehensive Analysis, Development Strategy, Future Plans and Industry Growth with High CAGR by…

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TABLE OF CONTENT:

1 Report Overview

2 Global Growth Trends

3 Market Share by Key Players

4 Breakdown Data by Type and Application

5 United States

6 Europe

7 China

8 Japan

9 Southeast Asia

10 India

11 Central & South America

12 International Players Profiles

13 Market Forecast 2019-2025

14 Analysts Viewpoints/Conclusions

15 Appendix

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Global Induced Pluripotent Stem Cells Market Size, Comprehensive Analysis, Development Strategy, Future Plans and Industry Growth with High CAGR by...