HOUSTON, Nov. 01, 2021 (GLOBE NEWSWIRE) — Coya Therapeutics, Inc. (“Coya”), a clinical-stage biotechnology company developing first-in-class approaches utilizing autologous regulatory T cells (Treg) and Treg-derived exosome therapeutics for neurodegenerative and autoimmune diseases, today announced the appointment of Adrian Hepner, M.D., Ph.D. as Chief Medical Officer and Greg MacMichael, Ph.D. as Chief Technical Officer, effective immediately. Dr. Hepner will drive the ongoing clinical and regulatory advancement of Coya’s expanding pipeline, and Dr. MacMichael will oversee manufacturing and process development.
“We are very pleased to welcome both Adrian and Greg, especially as we approach a significant inflection point and anticipate topline data following our recently completed Phase 2a trial,” said Howard Berman, Ph.D., Chief Executive Officer of Coya Therapeutics. “Adrian’s extensive leadership experience, strategic clinical-regulatory knowledge and neurology background make him exceptionally well qualified to drive the advancement of Coya’s expanding pipeline and lead investigational drug, COYA101: an autologous, expanded Treg cell therapy in development for the treatment of amyotrophic lateral sclerosis (ALS). On the manufacturing end, Greg brings scientific acumen, broad drug development expertise and experience in establishing the necessary processes to maximize the potential of our proprietary platform. With these tremendous additions to our leadership team, we now have the necessary capabilities to advance our Treg programs through the clinic and beyond.”
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.
Dr. Hepner added, “I am excited to join Coya, whose emerging data suggest COYA101 may slow and halt the progression of ALS and ultimately provide superior clinical benefit by harnessing the neuro-protective effects of Treg cell therapy. I look forward to working with Coya’s outstanding team to maximize the full potential of Coya’s proprietary platform technology, optimize our clinical development plans, and work with regulatory agencies to bring COYA101 to patients as efficiently and quickly as possible.”
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.
Dr. MacMichael added, “I am impressed with Coya’s disruptive platform technology, which is the first in the industry to expand, freeze and re-thaw Tregs, allowing for serial and monthly maintenance infusions while maintaining viability and suppressive function. With this capability, Coya has the potential to transform the treatment landscape for patients with neurodegenerative and autoimmune diseases. I look forward to working with the team to translate strategies into tactical programs and further optimize effective manufacturing and development processes.”
About Coya Therapeutics, Inc.
Headquartered in Houston, TX, Coya Therapeutics (TM) is a clinical-stage biotechnology company developing first-in-class and best-in-class approaches utilizing adoptive regulatory T cells (Tregs) to target disease. The company’s CTreg (TM) (Cryopreservation for Tregs) system is patent pending and the first in the industry to overcome prior limitations of Treg cell therapies, allowing for serial infusions from a single manufacturing run. Coya’s proprietary TAI™ (Tregs Against Inflammation™) involves the conversion of millions of dysfunctional Tregs into billions of “Super Tregs”, with superior immunosuppressive functionality. Our patent pending iscEXO (TM) (immunosuppressive cell Exosome) platform is a Treg derived exosome asset focused on the advancement of disease modifying approaches to address the significant unmet medical needs of patients with ALS, Frontotemporal Dementia, Parkinson’s, Alzheimer’s, and autoimmune diseases. For more information, please visit