Coya Therapeutics Announces Publication of Potential Novel Blood Biomarker Data in Amyotrophic Lateral Sclerosis (ALS) Patients That Accurately Reflect Therapeutic Responses When Treated with Regulatory T Cell (Treg) Enhancing Therapies

• Pathological hallmarks of ALS are characterized by alterations in inflammation and oxidative stress, with oxidative stress playing a critical role in neuronal damage.
• 4-hydroxy-2-nonenal (4-HNE) is a key mediator of oxidative stress in cells and tissues.
• Analysis of blood biomarker data from two clinical trials of Treg-enhancing therapies in patients with ALS demonstrated a strong correlation between clinical response and levels of 4-HNE and inflammatory biomarkers monocyte chemoattractant protein-1 (CCL2) and interleukin (IL-18).
• Coya intends to leverage these correlative biomarkers in its planned fully powered placebo controlled clinical trial with COYA 302 in patients with ALS.

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, including biologics and cell therapies, today reported the publication of a research article entitled “Immunological, Oxidative, and Structural Factors and Their Responses to Regulatory T Lymphocyte Therapy in Amyotrophic Lateral Sclerosis” in the peer-reviewed journal Ageing and Neurodegenerative Diseases. The publication can be accessed here.

The publication reports the analyses of blood biomarker data from a cross sectional cohort of sporadic ALS patients (n = 30) and healthy controls (n=10) and from two investigator-initiated clinical studies (IIT) (n=11). In the IIT studies, patients were treated with expanded Treg cell therapy in combination with low-dose interleukin-2 (IL-2). As previously reported, patients from these two trials experienced amelioration of disease progression with corresponding increased Treg numbers and suppressive function.

Evidence strongly supports the role of inflammation and oxidative stress in the severity and rate of disease progression in ALS. These new biomarker data demonstrate that enhancing Treg function improves clinical outcomes with accompanying changes in blood levels of oxidative stress markers, such as 4-HNE, and inflammatory markers, including CCL2 and IL-18, and may have the potential to serve as objective biomarkers of disease progression and clinical trial endpoint surrogates to therapies that enhance Treg function.

Stanley Appel, M.D., Chairman of Coya’s Scientific Advisory Board, commented, “Our pre-clinical studies have suggested that oxidative stress results from and promotes neuroinflammation and neuronal injury in ALS. It is gratifying that biomarkers of oxidative stress - 4-HNE and ox-LDL - correlated with responsiveness to therapy in 2 ALS clinical trials of Treg-enhancing therapies, and may provide an objective confirmation of clinical benefit in forthcoming trials.”

Following these encouraging results, Coya plans to assess blood markers of oxidative stress and inflammation systematically and prospectively in the upcoming well powered placebo controlled clinical study of COYA 302 (Treg-enhancing biologic combination) in patients with ALS, aiming to provide a better understanding of the disease, with the ultimate goal of developing consistent biomarkers to evaluate treatment response.

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 include 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 (proprietary low dose IL-2) for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination (proprietary low dose IL-2 and proprietary CTLA4-Ig) 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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