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

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.