- Dr. Frazier brings over 20 years of strong regulatory expertise since her tenure at the FDA followed by a successful career in the pharmaceutical industry.
- Dr. Frazier spent 7 years at the FDA, where she was a team lead reviewing over 60 new molecular entities, overseeing multiple biologic license applications, including the first anti-angiogenic monoclonal antibody approved for cancer therapy. In turn, she was recognized multiple times for her leadership and excellence.
- Subsequent to FDA, Dr. Frazier has demonstrated a proven track record for overseeing and guiding successful global regulatory strategies at prestigious bio pharmaceutical companies for numerous biologic drug products leading to FDA approval of multiple biologic license applications and supplements, including Udenyca® (pegfilgrastim-cbqv biosimilar), and Blincyto®, the first bispecific monoclonal antibody product. As part of her career, Dr. Frazier has also provided strategic advice to multiple biotechnology companies.
- Dr. Frazier received a B.S in Microbiology from Washington State University and a Ph.D. In Cell Biology from Loyola University.
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, today announced the appointment of Dr. Michelle Frazier, Ph.D. to Coya’s management team as Senior Vice President of Regulatory Affairs. Dr. Frazier will leverage her regulatory and CMC expertise to guide and oversee all of Coya’s regulatory submissions including the upcoming IND submission for COYA 302 for the treatment of Amyotrophic Lateral Sclerosis (ALS).
“Dr. Frazier has proven time and again that she has the expertise and ability to take biologics across the finish line to FDA approval. She has overseen the entire regulatory and submission process for biologic drugs from start to finish at multiple organizations and I am confident she will do the same for Coya. Her deep understanding of FDA requirements and practices makes her a strong addition to our growing organization,” stated Howard H. Berman, Ph.D., CEO of Coya Therapeutics.
Dr. Frazier commented: “Coya is developing highly promising multimodal Treg therapies for the treatment of neurodegenerative diseases of high unmet need. I look forward to joining the distinguished team at Coya and share both the urgency and the commitment to make these products a reality for our patients and their families, if approved by the regulatory authorities.”
Udenyca® is a registered trademark of Coherus BioSciences.
Blincyto® is a registered trademark of Amgen.
About Coya Therapeutics, Inc.
Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s lead therapeutic programs includes Treg-enhancing biologics (COYA 300 Series product candidates) COYA 301 and COYA 302, which are intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. For more information about Coya, please visit www.coyatherapeutics.com
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