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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

 
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Senior Management

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Howard Berman, Ph.D.

Chief Executive officer and Chairman of the Board

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Adrian Hepner M.D., Ph.D.

Chief Medical Officer

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Gene Mack, MBA

Chief Financial Officer

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Gregory MacMichael, PH.D.

Chief Technical Officer

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Aaron Thome, Ph.D.

Head of Neuroinflammation Platform

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David Beers, Ph.D.

Head of Biomarker Program

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Michael Mendicino, Ph.D.

CMC and Regulatory Consultant

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Mary W. Keville, B.S., MPH

Quality and Compliance Consultant

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Howard Berman, Ph.D.

Chief Executive Officer and Chairman of the Board

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 Chairman and 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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Josh Blacher

Interim Chief Financial Officer

Coming soon

 

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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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DAVID BEERS, PH.D.

Head of Biomarker Program

Coming soon

 

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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. 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 and Compliance 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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Adrian Hepner M.D., Ph.D.

Chief Medical Officer

Dr. Hepner has over 30 years of global experience in clinical research and drug development, including the development and implementation of the clinical and regulatory strategy for several products from early stage through successful New Drug Application (NDA) and EU regulatory filings and approvals. Dr. Hepner’s pharmaceutical industry experience includes over 20 years of elevating leadership roles in drug development. He previously served as Chief Medical Officer and Head of R&D at Pharnext and Executive Vice President and Chief Medical Officer at Eagle Pharmaceuticals. He has also held the positions of Vice President of Clinical Research at Avanir Pharmaceuticals, where he had a critical role in the development and approval of Nuedexta, a first-in-class product for the treatment of pseudobulbar affect, Vice President of Clinical Research and Medical Affairs at BioDelivery Sciences International (BDSI), where he led the regulatory process for the first buccal film approved for the maintenance treatment of opioid dependence. In addition, he had a critical role in the commercial launch of the product. Prior to BDSI, Dr. Hepner was senior medical director at UCB BioSciences, Inc., where he was responsible for global development projects in the central nervous system therapeutic area and led global clinical research projects in Latin America for Teva Pharmaceuticals. Dr. Hepner has authored multiple publications, holds several patents and spent 17 years as a practicing physician specializing in neuropsychiatry. Dr. Hepner completed visiting research physician experiences in the Department of Psychiatry at Harvard Medical School, the Department of Neurology at the National Institute of Mental Health, and a post-doctoral fellowship in neuropharmacology at the University of Ottawa. Dr. Hepner received his M.D., and Ph.D., from Universidad de Buenos Aires.

 

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GENE MACK, MBA

Chief Financial Officer

Mr. Mack has over 25 years of experience in the life sciences sector spanning clinical research, financing, investing, corporate strategy and business development with private and public companies. Prior to joining Coya Therapeutics in 2021, Mr. Mack was Chief Financial Officer of OncoC4 overseeing the spin-out and negotiation of Merck MSD’s acquisition of OncoImmune. Since 2014, he has held the CFO role for several private and public biotechnology and pharmaceutical companies raising over $250 million in IPO and secondary financing proceeds in addition to negotiating pre- and post-commercialization collaborations. Prior to his operational experience, Mr. Mack was a senior publishing analyst covering the life sciences sector at various banking institutions, including Gruntal & Co, Lazard Capital Markets, and HSBC. Before his tenure on Wall Street, Mr. Mack completed research in biochemistry at Cornell University Medical College and clinical neurology at Columbia University College of Physicians and Surgeons where he was part of a team investigating less invasive treatments for malignant gliomas and cerebrovascular disease, including aneurysms, arteriovenous malformations and stroke. Mr. Mack received his BS in Biochemistry and MBA in Finance from Fordham University.

 

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Gregory MacMichael, PH.D.

Chief Technical Officer

Dr. MacMichael has nearly 40 years of biopharmaceutical experience, including in the development and manufacturing of biologics. Most recently, he was Chief Technology Officer of Castle Creek Biosciences, Inc., and President of CMC Bioservices, a consultancy focused on the development and manufacturing of cell and gene therapies, biologics and vaccines. Previously, he served as the Senior Vice President of Technology for Axovant Sciences, Senior Vice President of Development, Manufacturing and Quality Control at NantKwest, and Senior Vice President of Process, Development, Manufacturing and Quality Assurance at Rocket Pharma. He has also served as the Global Head of Biologics Process Development at Novartis, leading the chemistry, manufacturing and control (CMC) aspects of Novartis’ acquisition and transfer of Kymriah® from the University of Pennsylvania, including building the supply chain for plasmids, lentiviral vector and production capacity. Dr. MacMichael has worked with various notable companies, including Novartis, Wyeth, Eli Lilly, Chiron, Centocor and Cook. Dr. MacMichael received his Ph.D. in microbiology/biochemistry from Mississippi State University, his M.S. in microbiology/biochemistry from North Carolina State University and his B.S. in microbiology from Pennsylvania State University.

 

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Board of Directors

HOWARD BERMAN, PH.D.

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 Chairman and 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.

Anabella Villalobos, Ph.D.

As head of Biotherapeutics and Medicinal Sciences at Biogen, Dr. Villalobos is responsible for the delivery of high-quality, differentiated drug candidates that advance through the clinic to become transformative medicines. Additionally, she has built a new gene therapy unit, setting the initial direction of effort including hiring the first team.

Prior to Biogen, Dr. Villalobos was at Pfizer for 28 years where she most recently served as Vice President of Medicinal Synthesis Technologies and Neuroscience Medicinal Chemistry. As the leader of several medicinal chemistry groups throughout her tenure at Pfizer, Dr. Villalobos’ teams delivered more than 30 candidates which showed increased survival to the clinic. Noteworthy were clinical candidates to combat Alzheimer’s disease, Parkinson’s disease, schizophrenia, depression, insomnia, and stroke. Among other accomplishments, she contributed to the design and discovery of CP-118,954 (icopezil), an acetylcholinesterase inhibitor, which was advanced to Phase II clinical trials for Alzheimer’s disease. This candidate became part of the agreement that led to the successful co-promotion of Aricept by Pfizer and Eisai. Dr. Villalobos has also championed new scientific directions that have improved design practices in medicinal chemistry including the Central Nervous System Multi-Parameter Optimization (CNS MPO) design tool and a novel PET ligand design and discovery approach.

Dr. Villalobos obtained her B.S. in Chemistry at the University of Panama and her Ph.D. in Medicinal Chemistry at the University of Kansas where she was a Fulbright-Hayes fellow. She was a National Institutes of Health Postdoctoral Fellow at Yale University in synthetic organic chemistry for two years.

Ann Lee, Ph.D.

At BMS, Dr. Lee leads teams responsible for developing new cell therapy processes and technologies, manufacturing cell therapy products, designing new facilities, and building the global supply chain to deliver these new medicines for patients. Previously, she served as Executive Vice President of Technical Operations at Juno Therapeutics, which was acquired by BMS via Celgene. Prior to Juno, Dr. Lee joined Genentech in 2005, and she became SVP, Genentech and Head of Global Technical Development at Roche in 2009. She was responsible for developing and delivering all clinical stage products in Roche’s global pipeline, as well as technology transfers and technical support for all commercial products. Earlier, she was at Merck & Co., where she led and developed new vaccines and technologies in R&D, and then was responsible as VP for process engineering and technical operations at 10 chemical sites around the world. Over the course of her career, she has contributed to the development of hundreds of new investigational drugs, and the licensure and commercialization of 25 new vaccines and medicines, with the most recent being two new CAR-T cell products for blood cancers.

Dr. Lee has authored over 40 scientific publications and holds several patents. She is a member of the National Academy of Engineering, fellow of American Academy of Arts and Sciences, American Institute of Medical and Biological Engineering, and member of the Washington State Academy of Sciences. She serves on the Board of Directors for American Institute of Chemical Engineers, the Alliance of Regenerative Medicine, and JW Therapeutics. She earned her undergraduate degree from Cornell University and a masters and Ph.D. in Biochemical Engineering with a concentration in molecular biophysics and biochemistry from Yale University.

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.