Coya Therapeutics to Present Novel Biomarker Survival Data in Large Cohort of ALS (Amyotrophic Lateral Sclerosis) Patients at Society of Neuroimmune Pharmacology Conference

Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces that Dr. Stanley Appel, M.D., Chairman of Coya’s Scientific Advisory Board, will present data on its novel oxidative stress biomarker candidate from a large cohort of Amyotrophic Lateral Sclerosis (ALS) patients at the upcoming Society of Neuroimmune Pharmacology Conference being held on March 10-13, 2024 in Charleston, SC. Dr. Appel’s presentation will be on Tuesday, March 12th, 2024, and is titled Immunomodulatory Therapy in Neurodegenerative Disease: Lessons from ALS.

Dr. Fred Grossman, Coya’s Chief Medical Officer, stated: “Neurofilament Light Chain (NFL), despite its lack of specificity for ALS, is currently the only robust and validated biomarker used for diagnostic and prognostic performance in symptomatic ALS patients. Less than a year ago, the FDA approved Tofersen for the treatment of ALS associated with a mutation in the superoxide dismutase gene based on its ability to lower NFL blood levels. We believe that our preliminary novel biomarker data may facilitate new opportunities to better predict patient survival, monitor disease progression, and track efficacy of therapies and will be an important part of the analysis in the upcoming Ph. 2 COYA 302 ALS study.”

Investors can register for The Society of Neuroimmune Pharmacology Conference here.

About COYA 302

COYA 302 is an investigational and proprietary biologic combination therapy 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, FTD, and PD. These mechanisms may have additive or synergistic effects.

In February of 2023, Coya announced results from a proof-of-concept, open-label clinical study evaluating commercially available LD IL-2 and CTLA-4 Ig in a small cohort of patients with ALS conducted at the Houston Methodist Research Institute (Houston, Texas) by Stanley Appel, M.D., Jason Thonhoff, M.D., Ph.D., and David Beers, Ph.D. This study was the first-of-its-kind evaluating this dual-mechanism immunotherapy for the treatment of ALS. Patients in the study received investigational treatment for 48 consecutive weeks and were evaluated for safety and tolerability, Treg function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the ALSFRS-R scale.