• COYA 302 is an investigational and proprietary biologic combination with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages;
• COYA 302 is comprised of proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig, and is being developed for subcutaneous administration for the treatment of patients with ALS;
• The experimental data generated in cell samples from ALS patients highlight the significant positive effect of LD IL-2/CTLA4-Ig and other Treg-enhancing therapies in reducing the inflammatory environment observed in ALS. It is known that the degree of neuroinflammation directly correlates with the severity and rate of progression observed in ALS;
• Coya is actively planning its next clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS.

HOUSTON / Oct 05, 2023 / Business Wire / Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics and cell therapies intended to enhance the function of Tregs, announced new experimental data presented at the 22^nd Annual Northeast ALS (NEALS) Consortium Meeting on October 4^th, 2023. Details of the study can be found here.

Results of the in vitro study in samples from ALS patients highlight the deleterious role of M1 pro-inflammatory monocytes and macrophages in the ability of Tregs to maintain their immunomodulatory anti-inflammatory function and achieve immune homeostasis. Tregs are often dysfunctional in ALS, exhibiting low anti-inflammatory suppressive function. The degree of impaired Treg function has been shown to directly correlate with the severity and rate of progression of this life-threatening disease.

Prior studies conducted by Dr. Appel and his team at the Houston Methodist Hospital demonstrated that dysfunctional Tregs from ALS patients can be successfully expanded ex vivo restoring their suppressive function, but when Tregs were infused back to the patients the anti-inflammatory function had limited duration. Subsequent studies have identified that the inflammatory environment created by myeloid cells could be a key contributor to the loss of Treg suppressive function.

The present in vitro research work studied the interactions between expanded Tregs and activated monocytes and macrophages, and the ability of immunomodulatory drugs and other Treg-enhancing therapies to increase Treg anti-inflammatory function and suppress the pro-inflammatory function of the M1 phenotype of activated monocytes and macrophages.

Main results of the study are summarized below:

• M1 activated monocytes and macrophages reduce Treg viability and upregulate apoptosis markers.
• Immunomodulatory drugs known to suppress the M1 phenotype significantly decreased the production of inflammatory cytokines involved in tissue damage.
• The combination of LD IL-2/CTLA4-Ig significantly decreased the M1 phenotype and cytokine production and maintained Treg viability.

Results of this study further support the potential of COYA 302 (LD IL-2 and CTLA4-Ig) to address the multiple pathways involved in the progression and severity of ALS. Coya is working expeditiously in the planning and execution of its next clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS.

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 proprietary investigational recombinant human low dose IL-2 biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a dual-mechanism investigational biologic combination comprised of proprietary low dose IL-2 and CTLA-4 Ig. The low dose IL-2 is intended to enhance anti-inflammatory regulatory T cell function and numbers while the fusion protein CTLA-4 Ig is intended to suppress pro-inflammatory cell function. 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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