Coya Therapeutics Announces Publication of GLP-1/LD IL-2 Combination Biologic (COYA 303) Demonstrating Synergistic Enhancement of Regulatory T Cell Function and Protection Against Treg Apoptosis (Cell Death)

Associated Press

21-04-2025

HOUSTON--(BUSINESS WIRE)--Apr 21, 2025--
Coya Therapeutics, Inc. (NASDAQ: COYA) ('Coya' or the 'Company'), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, today announced publication of the results of a study designed to evaluate the effects of COYA 303 (LD IL-2 and GLP-1RA), Coya's investigational biologic combination to suppress pro-inflammatory myeloid cells, enhance Treg suppressive function, and modulate T cell proliferation, in an in vitro system of human immune cells obtained from healthy donors. The research was conducted at the Houston Methodist Research Institute and was led by Dr. Aaron Thome and Dr. Stan Appel. The research article has been published in the Journal NeuroImmune Pharmacology and Therapeutics and can be accessed here.
Dr. Arun Swaminathan, Coya's Chief Executive Officer, stated, 'We believe COYA 303 could offer a differentiated and synergistic approach to addressing multiple conditions, including in neurodegenerative conditions such as Alzheimer's Disease, in which GLP-1 RAs have recently shown promise. We believe the potential of this proprietary combination could lead to value-creating opportunities and may open up a new avenue of research within the GLP-1RA drug class.'
LD IL-2 preferentially binds the IL-2 receptor alpha, which is predominantly expressed on Tregs to enhance their anti-inflammatory suppressive function. Treg dysfunction has been well documented in several autoimmune and neurodegenerative diseases characterized by persistent inflammation. GLP-1RAs also exhibit several immune-modulating effects, with myeloid cells and regulatory subsets, such as Tregs, expressing a large concentration of GLP-1 receptors. Although increased Treg numbers and enhanced suppressive function are seen with LD IL-2 treatment, their longevity and suppressive function can be limited by the effects of pronounced and sustained inflammatory environments. Therefore, a combination therapy approach that dampens the inflammatory microenvironment while enhancing Treg survival and function may provide synergistic anti-inflammatory therapeutic effects.
Dr. Fred Grossman, Coya's Chief Medical Officer commented, ' We believe the encouraging results of this study provide support for our multi-targeted combination approach as a potentially viable treatment option for serious and life-threatening conditions of high unmet need driven by chronic inflammation and Treg dysfunction, for which currently available treatments provide limited benefits.'
Summary of Study Results
Following pro-inflammatory activation of myeloid cells co-cultured with Tregs, the addition of COYA 301 (LD IL-2) alone enhanced Treg suppressive function by 15%. Similarly, when GLP-1RA alone was added to the system, Treg suppressive function increased by 20%. In contrast, when COYA 303 was added to the cell system a statistically significant increase in Treg suppressive function of 42% (p < 0.001) was observed, when compared to the increase observed with each of the single agents.
Consistent with these results, treatment with COYA 303 promoted Treg survival by modulating the apoptotic pathway. COYA 303 significantly reduced BAX transcript levels during prolonged incubation (p < 0.01). These findings suggest a direct effect of COYA 303 supporting Treg survival through the inhibition of Treg apoptosis.
These data show that the combination approach of COYA 303 enhances Treg suppressive function in highly inflammatory microenvironments, while also promoting Treg survival by preventing apoptosis.
Additional details and results of the research study can be found here.
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 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 therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.
For more information about Coya, please visit www.coyatherapeutics.com
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SOURCE: Coya Therapeutics, Inc.
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PUB: 04/21/2025 09:51 AM/DISC: 04/21/2025 09:51 AM
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