Tenaya Therapeutics to Present Preclinical Data at 2020 Annual Meeting of the American Society of Gene & Cell Therapy
SOUTH SAN FRANCISCO, Calif., May 11, 2020 – Tenaya Therapeutics, Inc., a company with a mission to discover, develop, and deliver potentially curative therapies that target the underlying causes of heart disease, today announced that it will present preclinical data from four studies as posters at the 23rd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), being held May 12-15, 2020, in a virtual format.
Three posters illustrate advances made with Tenaya’s Cellular Regeneration platform using direct reprogramming of resident cardiac fibroblasts to create new cardiomyocytes. The fourth poster illustrates advances made with the Company’s Gene Therapy platform to identify novel adeno-associated virus (AAV) variants with superior attributes to parental serotypes, that can be used develop best-in-class therapies for several undisclosed genetic cardiomyopathies under development.
Faraz Ali, Chief Executive Officer, stated, “These data highlight important advances in our science, our capabilities, and our intellectual property since Tenaya was founded in 2016. They confirm the potential for our three product platforms to address both rare and prevalent forms of heart disease, the leading cause of death in the world. The compelling efficacy demonstrated with our cardiac reprogramming project in a relevant large animal model is an important step forward for the field of cardiac regeneration, and supports advancement of this innovative approach toward the clinic as a first-in-class therapy for patients with heart failure following a myocardial infarction.”
Details of Tenaya’s poster presentations at ASGCT are as follows:
Abstract 273
Lombardi et al., Cardiac Direct Reprogramming Gene Therapy for Ischemic Injury
Poster Session Date/Time: Tuesday, May 12, from 5:30 to 6:30pm ET
Session Title: Cardiovascular and Pulmonary Diseases
Abstract 279
Yang et al., Efficacy of Cardiac Reprogramming via Gene Therapy in Rat with Chronic Heart Failure
Poster Session Date/Time: Tuesday, May 12, 5:30 to 6:30pm ET
Session Title: Cardiovascular and Pulmonary Diseases
Abstract 280
Reid et al., Engineering Novel rAAV Vectors with Enhanced Cardiac Tropism
Poster Session Date/Time: Tuesday, May 12, 5:30 to 6:30pm ET
Session Title: Cardiovascular and Pulmonary Diseases
Abstract 599
Srinath et al., Developing an Optimized Cardiac Reprogramming Cocktail for Gene Therapy in Humans
Poster Session Date/Time: Wednesday, May 13, 5:30 to 6:30pm ET
Session Title: AAV Vectors – Preclinical and Proof-of-Concept Studies
All abstracts for the ASGCT Annual Meeting will be available on ASGCT’s website at https://www.asgct.org/. These poster presentations will later be available on the Company’s website at http://www.tenayatherapeutics.com.
About Tenaya’s Three Product Platforms for Heart Disease
Tenaya is advancing first-in-class product candidates from three separate platforms – Cellular Regeneration, Gene Therapy, and Precision Medicine. The Cellular Regeneration platform uses novel adeno-associated virus (AAV) vectors to deliver proprietary transcription factors that can drive in vivo reprogramming of resident cardiac fibroblasts into cardiomyocytes, with an initial focus on acute and chronic injury following a myocardial infarction. The Gene Therapy platform uses AAV vectors for the targeted delivery and expression of therapeutic payloads to specific cells in the heart, with an initial focus on the treatment of genetically defined cardiomyopathies. The Precision Medicine platform uses isogenic iPSC-derived cardiomyocytes as human disease models to identify and validate new heart failure targets and to screen for therapeutic compounds, with an initial focus on small molecules for the treatment of several genetically defined dilated cardiomyopathies.
About Tenaya Therapeutics, Inc.
Tenaya Therapeutics is a biopharmaceutical company with a mission to discover, develop, and deliver potentially curative treatments that target the underlying causes of heart disease. Tenaya is advancing multiple candidates from three product platforms – Cellular Regeneration, Gene Therapy, and Precision Medicine. Headquartered in South San Francisco, California, Tenaya was founded by world-leading scientists from the Gladstone Institute’s Cardiovascular Division and from the University of Texas Southwestern Medical Center. For more information, please visit www.tenayatherapeutics.com.
Media contact:
Kathy Vincent
(310) 403-8951
kathy@kathyvincent.com
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Tenaya Therapeutics Closes $92 Million Series B Financing
– Proceeds advance heart disease projects from three product platforms toward the clinic –
SOUTH SAN FRANCISCO, Calif., October 3, 2019 – Tenaya Therapeutics, Inc., a company with a mission to discover, develop, and deliver curative therapies that target the underlying causes of heart disease, today announced the successful completion of a $92 million Series B financing.
The financing round was led by Casdin Capital and included GV, The Column Group, and additional undisclosed new and existing investors. Tenaya has raised $142 million since its founding by scientists at the Gladstone Institutes and University of Texas Southwestern Medical Center in October 2016.
Proceeds from the financing will be used to advance and to expand Tenaya’s pipeline and to strengthen the science, capabilities, and intellectual property that provide the foundation for Tenaya’s multi-modality product platforms – Cellular Regeneration, Gene Therapy, and Precision Medicine.
“We are now well-resourced to build on our capabilities in research and manufacturing, and to accelerate the development of our lead gene therapy and small molecule projects for both orphan and prevalent heart diseases towards the clinic,” said Faraz Ali, Chief Executive Officer of Tenaya. “We are pleased to have a group of experienced private and public investors led by Casdin Capital and The Column Group who support the potential for Tenaya’s science to transform the treatment of heart failure, the leading cause of death in the world.”
In connection with the Series B round, Eli Casdin, Chief Investment Officer, Casdin Capital, will join Tenaya’s Board of Directors, and Anthony Philippakis, M.D., Ph.D., Venture Partner, GV, will join as Board Observer.
“Tenaya is building a new type of company that views heart disease through the lens of human genetics and that is advancing a diverse set of therapeutic tools to correct it,” said Mr. Casdin. “It is a unique company in the field of cardiovascular disease, built on a world-class scientific foundation and driven by a growing team of entrepreneurs and drug developers. We look forward to being a supportive partner in the company’s important and exciting future.”
About Tenaya’s Three Product Platforms for Heart Disease
Tenaya is advancing first-in-class product candidates from three separate platforms – Cellular Regeneration, Gene Therapy, and Precision Medicine. The Cellular Regeneration platform uses novel adeno-associated virus (AAV) vectors to deliver proprietary transcription factors that can drive in vivo reprogramming of resident cardiac fibroblasts into cardiomyocytes, with an initial focus on acute and chronic injury following a myocardial infarction. The Gene Therapy platform uses AAV vectors for the targeted delivery and expression of therapeutic payloads to specific cells in the heart, with an initial focus on the treatment of genetically defined cardiomyopathies. The Precision Medicine platform uses isogenic iPSC-derived cardiomyocytes as human disease models to identify and validate new heart failure targets and to screen for therapeutic compounds, with an initial focus on small molecules for the treatment of several genetically defined dilated cardiomyopathies.
About Tenaya Therapeutics, Inc.
Tenaya Therapeutics is a biopharmaceutical company with a mission to discover, develop, and deliver potentially curative treatments that target the underlying causes of heart disease. Tenaya is advancing multiple candidates from three product platforms – Cellular Regeneration, Gene Therapy, and Precision Medicine. Headquartered in South San Francisco, California, Tenaya was founded by world-leading scientists from the Gladstone Institute’s Cardiovascular Division and from the University of Texas Southwestern Medical Center. For more information, please visit www.tenayatherapeutics.com.
Media contact:
Kathy Vincent
(310) 403-8951
kathy@kathyvincent.com
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Tenaya Therapeutics Strengthens Leadership Team with Appointment of Two Biopharmaceutical Industry Veterans
–Company Expands Scientific Advisory Board with Addition of Experts in Cardiovascular Genetics, Gene Therapy and Molecular Biology–
South San Francisco, Calif. – March 13, 2019 – Tenaya Therapeutics, a biopharmaceutical company focused on developing potentially curative treatments for heart disease, today announced that it has strengthened its leadership team with the appointment of Whittemore Tingley, M.D., Ph.D., as Chief Medical Officer, and Kee-Hong Kim, Ph.D., as Senior Vice President of Manufacturing and Technical Operations. The Company also bolstered its Scientific Advisory Board (SAB) with the addition of gene therapy expert Mark A. Kay, M.D., Ph.D.; cardiovascular genetics expert Elizabeth McNally, M.D., Ph.D.; and protein misfolding expert Jonathan Weissman, Ph.D.
“Tenaya has experienced significant momentum since we were founded in 2016. Now, with the addition of Drs. Tingley and Kim to our growing executive team, and with three world-renowned scientists who are leaders in their respective fields joining our SAB, we have added to our capabilities and are better positioned to execute on our goal of advancing multiple modalities to transform the treatment of heart disease,” said Faraz Ali, Chief Executive Officer of Tenaya Therapeutics. “Dr. Tingley brings critical experience in cardiovascular drug development and Dr. Kim brings extensive experience in AAV gene therapy manufacturing that we need in-house to advance our research into the clinic. We also look forward to tapping into the scientific expertise of Drs. Kay, McNally and Weissman to help Tenaya develop treatments for patients suffering from heart failure of various underlying causes.”
Leadership Team Additions
Dr. Tingley, prior to joining Tenaya Therapeutics, served as Vice President of Clinical Research, Cardiology, at Cytokinetics. Before that, he spent nine years at Genentech/Roche, where he held positions of increasing responsibility. Most recently, he was Therapeutic Area Lead for Cardiovascular and Metabolism Research and Early Development. Prior to that, he held a position in clinical R&D at CardioDx. Earlier in his career, Dr. Tingley was Adjunct Assistant Professor of Medicine in the Cardiology Division at the University of California, San Francisco (UCSF), and cared for patients as an attending cardiologist in the UCSF Cardiology Faculty Practice. He earned an A.B. from Brown University and an M.D. and a Ph.D. from the Johns Hopkins University School of Medicine. He completed internship and residency programs at the Johns Hopkins Hospital, a cardiology fellowship at UCSF, and post-doctoral research at the Gladstone Institute of Cardiovascular Disease.
Dr. Kim has more than a decade of experience in drug manufacturing. Prior to joining Tenaya Therapeutics, he served as Senior Vice President, Head of Technical Operations, at Agilis Biotherapeutics, where he was responsible for manufacturing gene therapy drug products and establishing reliable clinical and commercial supply chains. Prior to that, he was Head of the Gene Therapy Process Development and Global CMC Lead for Gene Therapy at Shire. After serving as Director of Process Development at Avalanche Biotechnologies, Dr. Kim ran a biopharma consulting firm for drug product delivery. Earlier in his career, he was a Senior Process Development Engineer at Dendreon, where he supported cGMP manufacturing for the immunotherapy PROVENGE. He received a Ph.D. in chemical engineering from Colorado State University and completed post-doctoral training at Cornell University.
Scientific Advisory Board Additions
Dr. Kay is a leading researcher in the fields of gene therapy and adeno-associated virus (AAV) biology, including the identification of new AAV capsids. Dr. Kay is the Dennis Farrey Family Professor in Pediatrics, Head of the Division of Human Gene Therapy, and a professor in the Departments of Pediatrics and Genetics at Stanford University School of Medicine. He is one of the founders of the American Society of Gene and Cell Therapy, served as its president from 2005-2006, and was the recipient of its Outstanding Investigator Award. Dr. Kay has organized many national and international conferences, including the first Gordon Conference related to gene therapy. He is currently the deputy editor of Human Gene Therapy and serves on the editorial boards of other peer-reviewed publications. Dr. Kay has a B.S. in physical sciences from Michigan State University, and a Ph.D. in developmental genetics and an M.D. from Case Western Reserve University.
Dr. McNally, a cardiologist with expertise in cardiac genetics, established one of the first cardiovascular genetics clinics in the United States. Her research focuses on understanding the genetic mechanism of cardiovascular disease and using genetic signals to drive therapy development. Dr. McNally is the Elizabeth J. Ward Professor of Genetic Medicine at Northwestern University’s Feinberg School of Medicine, where she directs the Center for Genetic Medicine. Her translational work was recognized by an award from the Burroughs Wellcome Foundation and the Distinguished Clinical Scientist Award from the Doris Duke Charitable Foundation. She is the Vice Chair for the Council on Basic Cardiovascular Sciences of the American Heart Association and serves on the advisory boards for the Muscular Dystrophy Association and Parent Project Muscular Dystrophy. She is a past president of the American Society for Clinical Investigation and a member of the Association of American Physicians.
Dr. Weissman is a professor in the Department of Cellular and Molecular Pharmacology, UCSF Biomedical Sciences Graduate Program. Dr. Weissman’s research team studies how cells ensure that proteins fold into their correct shape, as well as the role of protein misfolding in disease and normal physiology. His team also develops experimental and analytical approaches for exploring the organizational principles of biological systems and globally monitoring protein translation through ribosome profiling. A broad goal of his work is to bridge large-scale approaches and in-depth mechanistic investigations to reveal the information encoded within genomes. He is a member of the National Academy of Sciences.
The other members of Tenaya’s SAB include:
• Deepak Srivastava, M.D., Co-Founder of Tenaya; President, Gladstone Institutes; The Younger Family Director, Gladstone Institute of Cardiovascular Disease; Director, Rodenberry Center for Stem Cell Biology and Medicine; and Professor, UCSF
• Eric Olson, Ph.D., Co-Founder of Tenaya; Founding Chair, Department of Molecular Biology, and Robert A. Welch Distinguished Chair and the Annie and Willie Nelson Professorship of Stem Cell Research, University of Texas Southwestern Medical Center
• Mark Fishman, M.D., Professor, Department of Stem Cell and Regenerative Biology, Harvard University; and Chief, Pathways Clinical Service, Massachusetts General Hospital
• Doug Mann, M.D., Lewin Chair and Professor of Medicine, Cell Biology and Physiology, and Chief of the Division of Cardiology, Washington University School of Medicine
About Tenaya Therapeutics
Tenaya Therapeutics is a privately-held biopharmaceutical company focused on developing potentially curative treatments for heart disease of various underlying causes. Headquartered in South San Francisco, Calif., Tenaya was founded in 2016 by world-leading scientists from the Gladstone Institute’s Cardiovascular Division and the University of Texas Southwestern Medical Center. Tenaya is addressing heart disease through three distinct and multi-modality platforms: a Target and Drug Discovery Platform, which uses isogenic iPSC-derived cardiomyocytes as disease models for genetically-defined cardiomyopathies; a Gene Therapy Platform, which enables the targeted delivery of therapeutic payloads to relevant cells in the heart using adeno-associated virus (AAV) vectors; and a Regeneration Platform, which uses novel approaches to enable in vivo reprogramming of cardiac fibroblasts to cardiomyocytes in response to acute or chronic injury. For more information, please visit Tenaya’s website at www.tenayatherapeutics.com and LinkedIn page.
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Contact:
Please direct media inquiries to media@tenayathera.com, partnering inquires to partnering@tenayathera.com, and career opportunity inquiries to careers@tenayathera.com
Tenaya Therapeutics appoints Faraz Ali as Chief Executive Officer
South San Francisco, CA – July 30, 2018 – Tenaya Therapeutics, a preclinical-stage biotechnology company focused on discovery and development of novel therapies for heart failure, announced the appointment of Faraz Ali as Chief Executive Officer.
“We are thrilled to bring Faraz on board as the new CEO,” said David Goeddel, Ph.D., Managing Partner at The Column Group and Chairman of the Board of Directors at Tenaya. “The Board felt his strategic vision, track record of relevant operational experience, and commitment to building a leading heart failure company over the long-term make him an outstanding choice for Tenaya.”
Mr. Ali will take over leadership of the company from JJ Kang, Ph.D., a Principal at The Column Group who has served as Tenaya’s founding President. Dr. Kang will continue to serve on the Board. “Faraz’s previous experiences with novel therapies for rare diseases as well as for larger indications will be a great asset to Tenaya as the company evaluates and advances its research pipeline towards the clinic. The breadth of his business experiences is an excellent complement to the deep scientific expertise at Tenaya,” said Dr. Kang.
“I am very excited to join forces with the Tenaya team, The Column Group, and the Gladstone Institutes at this important inflection point for the company and for the gene therapy field,” said Faraz. “I have been impressed with the quality and pace of science at Tenaya, and I look forward to building out the team and capabilities that we need to bring this science forward to the clinic and to advance therapies that can have a meaningful impact on the lives of individuals living with heart failure.”
Mr. Ali was most recently Chief Business Officer at REGENXBIO, where he had accountability for corporate development, commercial planning, portfolio strategy, alliance management, and corporate communications. Prior to that, he was a Vice President at bluebird bio, where he had accountability for new product planning, program management, patient advocacy, and external affairs. Mr. Ali also had roles of increasing global commercial leadership at Genzyme Corporation, where he helped launch multiple first-in-class enzyme replacement therapies for rare diseases. He started his career at General Electric, including technical roles at GE Healthcare and business assignments at GE Corporate. Mr. Ali received his M.B.A. degree from Harvard Business School and his B.S. degree from Stanford University.
About Tenaya Therapeutics
Tenaya Therapeutics is a privately-held biopharmaceutical company backed by The Column Group. The Company was founded in 2016 by leading scientists from the Gladstone Institute’s Cardiovascular Division and the University of Texas Southwestern Medical Center. Tenaya is dedicated to addressing heart failure through multipronged efforts that target the fundamental cellular pathologies present in diseased cardiac muscle and that leverage cutting-edge research in cardiac development and regeneration. Tenaya has a lead gene therapy program focused on in vivoreprogramming of cardiac fibroblasts to cardiomyocytes to regenerate heart tissue, and additional programs focused on cardiomyopathies.
Tenaya Therapeutics is headquartered in South San Francisco, California, USA. For more information, please visit the company’s website at https://www.tenayatherapeutics.com and LinkedIn page at https://www.linkedin.com/company/tenaya-therapeutics/.
Please direct media inquiries to media@tenayathera.com and partnering inquiries to partnering@tenayathera.com
Unlocking a cell’s potential to regenerate the heart
March 1, 2018 – ScienceDaily – Some organisms have a remarkable capacity for regenerating tissue. If a fish or salamander suffers heart damage, for instance, their cells are able to divide and successfully repair the injured organ. Imagine if you could do the same.
In the embryo, human heart cells can divide and multiply, allowing the heart to grow and develop. The problem is that, right after birth, cardiomyocytes (heart muscle cells) lose their ability to divide. The same is true for many other human cells, including those of the brain, spinal cord, and pancreas.
“Because so many adult cells can’t divide, your body can’t replace cells that are lost, which causes disease,” explained Deepak Srivastava, MD, president of the Gladstone Institutes and senior investigator. “If we could find a way to get these cells to divide again, we could regenerate a number of tissues.”
For decades, the scientific community has been trying to do just that, with limited success. Until now, attempts have been ineffective and poorly reproducible.
In a new study published in the scientific journal Cell, Srivastava and his team finally reached this long-sought goal. They developed the first efficient and stable method to make adult cardiomyocytes divide and repair hearts damaged by heart attacks, at least in animal models.
Over 24 million people worldwide suffer from heart failure, with few treatment options available other than heart transplants for end-stage patients. The potential to create new muscle cells through cell division, much like a salamander does, could offer new hope to the millions living with damaged hearts.
Unlocking an Adult Cell’s Potential to Multiply
Srivastava and his team identified four genes involved in controlling the cycle of cell division. They found that when combined — and only when combined — these genes cause mature cardiomyocytes to re-enter the cell cycle. This results in the cells dividing and rapidly reproducing.
“We discovered that when we increased the function of these four genes at the same time, the adult cells were able to start dividing again and regenerated heart tissue,” said Tamer Mohamed, scientist at Tenaya Therapeutics and former postdoctoral scholar in Srivastava’s laboratory, who is first author of the study. “We also showed that, after heart failure, this combination of genes significantly improves cardiac function.”
The scientists tested their technique in animal models and cardiomyocytes derived from human stem cells. They used a rigorous approach to track whether the adult cells were truly dividing in the heart by genetically marking newly divided cells with a specific color that could be easily monitored. They demonstrated that 15-20 percent of the cardiomyocytes were able to divide and stay alive due to the four-gene cocktail.
“This represents a considerable increase in efficiency and reliability when compared to previous studies that could only cause up to 1 percent of cells to divide,” said Srivastava, who is also a professor at UC San Francisco. “Of course, in human organs, the delivery of genes would have to be controlled carefully, since excessive or unwanted cell division could cause tumors.”
To further simplify their technique, the team looked for ways to reduce the number of genes needed for cell division while maintaining efficiency. They found they could achieve the same results by replacing two of the four genes with two drug-like molecules.
Regenerating Multiple Human Tissues
The researchers believe that their technique could also be used to coax other types of adult cells to divide again, given that the four genes they used are not unique to the heart.
“Heart cells were particularly challenging because when they exit the cell cycle after birth, their state is really locked down — which might explain why we don’t get heart tumors,” said Srivastava. “Now that we know our method is successful with this difficult cell type, we think it could be used to unlock other cells’ potential to divide, including nerve cells, pancreatic cells, hair cells in the ear, and retinal cells.”
This could lead to a powerful regenerative approach to treat not only heart failure, but also brain damage, diabetes, hearing loss, and blindness. And one day, the human might just outperform the salamander.
Tenaya Therapeutics appoints Tim Hoey, PH.D. as Chief Scientific Officer
SOUTH SAN FRANCISCO, Calif., November 1, 2017 – Tenaya Therapeutics, Inc., a privately-held biotech start-up dedicated to the discovery and development of novel therapeutics for the treatment of heart failure, announced the appointment of Tim Hoey, Ph.D. as chief scientific officer. Dr. Hoey is a biopharmaceutical executive with over two decades of experience in the industry.
Before joining Tenaya, he was senior vice president of Cancer Biology and co-chief scientific officer at OncoMed, where he led preclinical development and advanced multiple first-in-class agents to clinical testing. He also played a key role in establishing multiple corporate partnerships. Dr. Hoey entered the biotech industry as a scientist at Tularik, rising to a leadership role which he continued after Tularik’s acquisition by Amgen. Throughout his career, he has successfully led research teams in the discovery of drug targets and therapeutic agents in diverse fields including immunology, inflammation, and oncology.
“Tim Hoey brings a unique combination of scientific research prowess, drug development proficiency, and leadership needed for the realization of Tenaya’s ambitious goals,” said JJ Kang, Ph.D., president of Tenaya. “He has the vision and expertise required to advance our novel therapeutic strategies into viable clinical candidates.”
“Tenaya is an exciting new company with a talented team built on a great scientific foundation of discoveries by its founders” said Dr. Hoey. “We are focused on using innovative strategies to develop a new generation of therapeutics for the treatment heart failure, an area of tremendous medical need.”
About Tenaya Therapeutics, Inc.
Tenaya Therapeutics is a privately-held biopharmaceutical company backed by The Column Group and founded by leading scientists from The Gladstone Institute’s Cardiovascular Division and The University of Texas Southwestern Medical Center. Tenaya is dedicated to addressing heart failure through a multipronged effort that targets the fundamental cellular pathologies present in diseased cardiac muscle and leverages cutting-edge research in cardiac development and regeneration.
Tenaya Therapeutics is headquartered in South San Francisco, California. For more information, please visit the Company’s website at https://www.tenayatherapeutics.com.
Tenaya Therapeutics Launches
A new biopharmaceutical company, Tenaya Therapeutics Inc., will build on discoveries in cardiovascular disease research made at the Gladstone Institutes.