Coya Therapeutics, Inc.

Coya Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing new therapies to improve the function of regulatory T cells (Tregs). Tregs are a type of T-lymphocyte (CD4+CD25high hFOXP3+ cells) that reduce inflammation. Discovered in 1995 by Dr. Shimon Sakaguchi, who won the 2025 Nobel Prize in Physiology or Medicine, Tregs are crucial for maintaining cellular balance by regulating autoimmune and inflammatory responses and ensuring self-tolerance in mammals. Dysfunctional Tregs are linked to many diseases, often due to chronic inflammation and high oxidative stress. The severity of Treg dysfunction correlates with the progression of serious and life-threatening conditions. Coya's core focus is to develop therapies that address this Treg dysfunction, which is a key component of neurodegenerative, autoimmune, and metabolic diseases. The company has expertise in three potential therapeutic approaches: Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. These approaches include both ex vivo and in vivo methods designed to restore the suppressive and immune-modulating functions of Tregs. Coya's lead product, COYA 302, is a Treg-enhancing biologic. The company's autologous Treg cell therapy program has completed Phase 1 and Phase 2a studies for amyotrophic lateral sclerosis (ALS).