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Coya is developing disruptive, first in class, autologous regulatory T-cell (Treg) and allogeneic exosome therapies - leveraging the seminal discoveries from the laboratory of Stanley Appel M.D., in which dysfunctional Tregs modulate neurodegenerative and autoimmune diseases

Coya has revolutionized Treg cell therapy and Treg exosome manufacturing steps with cryopreservation techniques that allow for an industrialized supply chain management process - a single manufacturing run once per year produces enough patient doses or a full year’s supply that can be stored, shipped, rethawed, and infused at remote, outpatient facilities

A Unique Treg Phenotype: Coya's expanded Tregs exhibit a novel and reproducible composition of matter based on proteomic phenotypic characteristics that confirm their highly immunomodulatory and immunosuppressive activity

Coya has pioneered the ability to isolate dysfunctional Tregs from a patient, convert them to a highly functional and neuroprotective condition, and expand these cells into the billions for intravenous reinfusion back to the patient

The Core of Our Approach

Treg Cell Therapy Platform to Slow and Halt the Progression of Neurodegenerative Diseases

Mission

Offer patients a therapeutic strategy that aims to exponentially improve outcomes over the current standard of care by delaying disease progression and extending the lives of patients

 
Aboutus graph

Senior Management

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Howard Berman, Ph.D.

Chief Executive Officer

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Lou Vaickus, M.D. FACP

Acting Chief Medical Officer

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Aaron Thome, Ph.D.

Head of Neuroinflammation Platform

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Michael Mendicino, Ph.D.

CMC and Regulatory Consultant

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Mary W. Keville, B.S., MPH

Quality Control Consultant

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Howard Berman, Ph.D.

Chief Executive Officer

Howard co-founded Nicoya Health in 2020 to realize the vision and research of Dr. Stanley Appel and merged the company with Coya Therapeutics in 2021 where he currently serves as CEO.

He has over 18 years of entrepreneurial and industry experience working at the interplay of science and business. His experience offers him a unique combination of business acumen and scientific credibility with the ability to assess, quantify, and bridge both disciplines.

Howard gained corporate experience with increasing responsibilities and positions as a Medical Science Liaison at AbbVie where he spent 7.5 years launching Venetoclax in CLL and later, supporting numerous solid tumor assets. He also served in leadership roles at Novartis Pharmaceuticals and later Eli Lilly where he was the scientific point of contact between the company and key opinion leaders for development and initiation of collaborations, clinical trials and investigator initiated trials.

Howard began his career at MD Anderson Cancer Center in the technology transfer division where he was responsible for assessing the market, patent, and scientific merits of numerous oncology-based technology platforms in order to ascertain their commercial viability He received a Bachelor in Biology from the University of Michigan and a Masters and Ph.D. in Neuroscience and Pharmacology from Weill Cornell Medical School.

 

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Lou Vaickus, M.D. FACP

Acting Chief Medical Officer

Lou joins Coya to lead clinical and medical directives. He also serves as founder of akta Pharmaceutical Development LLC (aktaPD®) and has served as Interim Chief Medical Officer at several biotech companies, most recently for Vedanta, Verastem, Inc. and InVivo Therapeutics Holdings Corp. He has over 30 years of experience that began as an Academic Scientist, then practicing Physician, then spanned into industry with Preclinical, Clinical, and Globally Marketed Pharmaceutical Products. In industry, Lou served as Vice President and Head of Clinical Development, Global Medicines Development and Affairs at Vertex Pharmaceuticals. Before joining Vertex, he was Chief Medical Officer of Tolerx, Inc. Previously, he served as Vice President of Clinical Research and later as Senior Vice President of Medical Affairs at Sunovion (formerly Sepracor, Inc.), Medical Director of Oncology/Immunology at EMD Serono (formerly Ares Serono), where he supervised clinical and medical affairs for Rebif®, and Associate Medical Director, Medical Director, and later Medical Marketing Director for the Rebif® Multiple Sclerosis Strategic Business Unit at Serono. He is board certified in Internal Medicine, Hematology, and Medical Oncology. Lou completed postdoctoral fellowships in hematology, oncology, and immunology at the Mayo Clinic and Stanford University and has held faculty positions at the U of Iowa and at Roswell Park Cancer Institute/SUNY Buffalo. He holds an M.D. from Loyola University's Stritch School of Medicine.

 

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Aaron Thome, Ph.D.

Head of Neuroinflammation Platform

Aaron joins Coya to lead its Neuroinflammation Program and is responsible for developing and testing novel therapeutics that target inflammatory mechanisms which lead to disease pathogenesis. Aaron retains his position as Assistant Research Professor in the Department of Neurology at the Houston Methodist Neurological Institute, Johnson Center for Cellular Therapeutics, working closely with Dr. Stanley Appel (Coya Scientific Advisory Board), who is renowned for his discovery of Tregs as a treatment for inflammation in neurodegenerative diseases. Aaron’s transformational work includes elucidating neuroinflammatory mechanisms of neurodegenerative disease (ALS, Alzheimer’s, Parkinson’s, etc.) and developing therapeutic approaches to modulate or halt the progression of these devastating diseases. He completed his postdoctoral training with Dr. Appel at the Houston Methodist Neurological Institute, having received his Ph.D. from the University of Alabama at Birmingham at the Center for Neurodegeneration and Experimental Therapeutics. Aaron received his B.S. in Biomedical Science from Texas A&M University.

 

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Michael Mendicino, Ph.D.

CMC and Regulatory Consultant

Michael is a multi-disciplinary cell & gene therapy expert with over 23 years’ experience. A consultant and CEO, Michael has worked in the fields of cell therapy, gene and gene-modified cell therapies, other regenerative medicines, tissue engineering, and cell-based drug discovery, having served over 75 clients since his firm’s establishment. Previously he worked at four biotech companies, delivering services such as CMC, strategic regulatory affairs, regulatory submissions, R & D, commercial, and product & technology due diligence activities. Earning a Fellowship at the FDA, Michael worked in the Office of Tissues & Advanced Therapies (OTAT), where he performed regulatory submission review, special projects, and provided guidance to sponsors for OTAT-regulated products, and devices, including combination products. Michael earned a BS in Molecular Biology/Genetics and a Ph.D in Immunology at the University of Toronto, moved to the US, and continued his education with an MBA from Radford University. He co-chairs the Alliance for Regenerative Medicine (ARM) Science & Technology Committee) and co-founded and sits on the Board of Directors for the Standards Coordinating Body (SCB).

 

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Mary W. Keville, B.S., MPH

Quality Control Consultant

Mary consults with cell and gene therapy companies in various stages of development from pre-clinical to commercial. She has 30 years in the biologics manufacturing industry working for global pharmaceutical companies and CMOs, as well as with small biotech companies. Recently, she was the Global Quality Head for Lonza’s Cell and Gene Therapy Business Unit where she managed quality and compliance for seven cell and gene therapy manufacturing sites throughout North America, Europe and Asia. She has designed, developed, implemented, and directed quality and cGMP compliance programs at company sites, regions and globally for commercial biologics manufacturing. Mary is a subject matter expert in manufacturing processes and implementation of cGMP for cell and gene therapy products, Her substantial abilities in compliance, including successfully preparing for and responding to the FDA and foreign health authority pre-license approval inspections, assisting clients with critical FDA meetings and leading organizations back into compliance post FDA Warning Letters and Untitled Letters, is without peer. Mary holds a B.S. Medical Laboratory Science from Northeastern University and an MPH from Boston University.

 

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Board of Directors

Hideki Garren, M.D., Ph.D.

Dr. Garren has 20 years of experience in the biopharmaceutical industry, spanning all aspects of novel drug development from discovery, to early-stage clinical trials, to late-stage clinical trials, to commercialization. He currently serves as the Chief Medical Officer for Prothena, a late-stage clinical company with expertise in protein dysregulation, focusing on rare peripheral amyloid and neurodegenerative diseases. From 2013 to 2020, he served as VP, Global Head of Neuroimmunology for F. Hoffmann-La Roche (Roche) & Genentech Inc., where he led the teams that conducted the Ocrevus® Phase III trials for multiple sclerosis and Enspryng™ Phase III trials for the rare disease neuromyelitis optica spectrum disorder. Previously, Dr. Garren served as Executive Director, Translational Medicine Expert in neuroscience for Novartis Pharma.

In 2002, Dr. Garren co-founded Bayhill Therapeutics, centered on a novel therapeutic platform for treating autoimmune diseases that he co-discovered while at Stanford University, and served as Executive VP, Chief Scientific Officer and Chief Operating Officer. He served as adjunct clinical faculty in the Department of Neurology at Stanford University from 1997 to 2009. Dr. Garren earned his Bachelor of Science degree from the California Institute of Technology and his M.D. and Ph.D. from the University of California Los Angeles.

Dov Goldstein, M.D.

Dr. Goldstein brings over 20 years of strategic financial and operational experience within the healthcare sector. He currently serves as the Chief Financial Officer and Chief Business Officer of Indapta Therapeutics, a biotechnology company focused on developing and commercializing a proprietary, off-the-shelf, allogeneic FcRy-deficient natural killer (G-NK) cell therapy to treat multiple types of cancer. Dr. Goldstein was previously Chief Executive Officer of RIGImmune. Prior to that he served as the Chief Financial Officer at Schrödinger, LLC from 2017 to 2018. Dr. Goldstein held various leadership roles at Aisling Capital, a private investment firm, from 2006 to 2017, serving as its Managing Partner from 2014 to 2017. Dr. Goldstein served as the Chief Financial Officer of Loxo Oncology, Inc. between 2014 and 2015. From 2000 to 2005, Dr. Goldstein served as Chief Financial Officer of Vicuron Pharmaceuticals, Inc., raising over $250 million in equity financings, facilitating company partnership transactions and participating in the M&A process when Vicuron was acquired by Pfizer, Inc. for $1.9 billion. Prior to joining Vicuron, he was Director of Venture Analysis at HealthCare Ventures.

Dr. Goldstein currently serves on the board of Directors of NeuBase Therapeutics (Nasdaq: NBSE) and Gain Therapeutics (Nasdaq: GANX). He previously served as a director for ADMA Biologics, Loxo Oncology, Esperion Therapeutics, Duranta Therapeutics, Cempra and a number of private companies. He received a Bachelor of Science in biological sciences from Stanford University, an MBA from Columbia Business School and an M.D. from Yale School of Medicine.


 


Scientific Advisory Board

Shimon Sakaguchi MD, Ph.D.

Member- National Academy of Sciences

Dr. Shimon Sakaguchi is University Distinguished Professor at Osaka University and a member of the National Academy of Sciences. Dr. Sakaguchi is renowned for his discovery of regulatory T cells (Tregs), which can prevent autoimmunity but can also aid tumor survival and is the world’s authority of Treg biology and function. He was awarded the Medal with Purple Ribbon from the Emperor in 2009, designated as Person of Cultural Merit by the Japanese Government in 2017, and has been awarded many international prizes including Cancer Research Institute’s William B. Coley Award, Keio Medical Science Prize, Canada Gairdner International Award and Crafoord Prize.


Lawrence Steinman, M.D.

Member- National Academy of Sciences

Dr. Steinman is a professor of neurology and neurological sciences, pediatrics, and genetics at Stanford University Medical School and a member of the National Academy of Sciences and the National Academy of Medicine. He is a renowned expert on neuroinflammation and was senior author on the seminal 1992 Nature article that reported the key role of a particular integrin in brain inflammation, leading to the development of the drug Tysabri. He is the recipient of the John Dystel Prize from the American Academy of Neurology and the National Multiple Sclerosis Society for his research on MS, the Charcot Award from the Multiple Sclerosis International Federation, and the Anthony Cerami Award in Translational Medicine from Molecular Medicine.


Clive Svendsen, Ph.D.

Director of the Cedars-Sinai Regenerative Medicine Institute
Professor in Residence at UCLA
Consulting Professor at Stanford University

Dr. Clive Svendsen is Director of the Cedars-Sinai Regenerative Medicine Institute, Professor in Residence at UCLA and Consulting Professor at Stanford University. Dr. Svendsen is a renowned expert on stem cell biology and regenerative therapeutic approaches. He did his pre-doctoral training at Harvard University and received his PhD from the University of Cambridge in England, where he then established a stem cell research group before moving to the University of Wisconsin in 2000 to become Professor of Neurology and Anatomy, Director of an NIH-funded Stem Cell Training Program and Co-Director of the University of Wisconsin Stem Cell and Regenerative Medicine Center.


Malcolm Brenner, M.D., Ph.D.

Member- National Academy of Medicine

Dr. Brenner is the founding director of the Center for Cell and Gene Therapy and the Fayez Sarofim Distinguished Service Professor at Baylor College of Medicine. He is also a member of the Texas Children’s Cancer and Hematology Center, the Stem Cell and Regenerative Medicine Center, and the Dan L. Duncan Comprehensive Cancer Center at Baylor. Over the past 30 years, Dr. Brenner has devoted his career as a physician-scientist to the field of stem cell transplantation through the therapeutic use of T cell immunologic approaches and genetic engineering strategies. His lab was among the first to study the anti-leukemic effects of IL2 following stem cell transplantation during the 1980s and to study the safety and feasibility of post-transplant immunization. He served as Editor-in-Chief of Molecular Therapy and as former President of the American Society for Gene and Cell Therapy (ASGCT)and International Society for Cell Therapy.

Dr. Brenner has earned widespread recognition for his scientific achievements and leadership in the field, including the ASGCT Outstanding Achievement Award, Human Gene Therapy’s Pioneer Award, and the American Society of Hematology Mentor Award. He obtained his BA and medical degrees as well as his Ph.D. from the University of Cambridge in the UK where he became a fellow of the Royal College of Pathologists and the Royal College of Physicians. Dr. Brenner is a co-founder of AlloVir, formerly ViraCyte, LLC.


Stanley Appel, M.D.

Peggy & Gary Edwards Distinguished Endowed Chair
Chair, Stanley H. Appel Department of Neurology
Co-Director, Houston Methodist Neurological Institute
Houston Methodist Hospital
Professor of Neurology, Weill Cornell Medical College

Dr. Stanley Appel is the Peggy and Gary Edwards Distinguished Endowed Chair for the Treatment and Research of ALS, Co-Director of the Houston Methodist Neurological Institute, Chair of the Stanley H. Appel Department of Neurology, Houston Methodist Hospital and Professor of Neurology at Weill Cornell Medical College. He is also Director of the MDA/ALSA ALS Research and Clinical Center at the Houston Methodist Neurological Institute. Dr Appel’s seminal research documented the intimate relationship of neurodegeneration and ALS progression with dysfunctional and decreased levels of Tregs. He is also renowned for his discovery of cryopreservation of Tregs, demonstrating the ability to expand, freeze and re-thaw Tregs, while maintaining viability and suppressive function. Dr. Appel is a member of numerous professional societies and committees and has authored 15 books and over 440 articles on topics such as ALS, neuromuscular disease, Alzheimer’s Disease, and Parkinson’s Disease.