- The proof-of-concept open-label study evaluated the safety and tolerability, regulatory T cell (Treg) function, blood biomarkers, and preliminary efficacy of COYA 301 in eight patients with mild-to-moderate AD. The academic study was conducted by Dr. Appel and Dr. Faridar at the Houston Methodist Hospital.

- COYA 301 is Coya’s investigational low-dose interleukin-2 (IL-2) for subcutaneous administration. COYA 301 has been designed to enhance Treg anti-inflammatory function in vivo.

- Treg dysfunction has been identified as a key driver of neuroinflammation, which is observed in AD and other neurodegenerative diseases, and may contribute to disease progression.

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, today announced the presentation of results from an academic clinical study in patients with Alzheimer’s Disease (AD) with Coya’s COYA 301, its proprietary investigational proprietary biologic. The presentation will be made at the 2023 Keystone Symposia Neurodegeneration: New Biology Guiding the Next Generation of Therapeutic Development, to be held at Whistler, British Columbia, Canada from May 15-19^th, 2023.

The proof-of-concept open-label clinical study is the first-of-its-kind evaluating low-dose IL-2 immunotherapy for the treatment of AD. Patients in the study received investigational treatment with COYA 301 for four consecutive months and were evaluated for safety and tolerability, Treg function, serum biomarkers of inflammation, and clinical functioning as measured by the Mini-Mental State Examination (MMSE) and the Clinical Dementia Rating (CDR). COYA 301 is intended to enhance anti-inflammatory regulatory T cell function in vivo and has been designed to be administered subcutaneously to minimize treatment burden for patients and caregivers.

The study was conducted at the Houston Methodist Research Institute (Houston, Texas) and led by Stanley Appel, M.D. and Alireza Faridar, M.D. Dr. Appel is chair of Coya’s Scientific Advisory Board and is former chair of the Stanley H. Appel Department of Neurology. He is the director of the Ann Kimball & John W. Johnson Center for Cellular Therapeutics, Professor of Neurology at Weill Cornell Medical College, and the Peggy and Gary Edwards Distinguished Chair for the Treatment and Research of ALS at the Houston Methodist Research Institute.

Alzheimer’s disease is a progressive neurological condition usually seen in people over the age of 65 in which the death of brain cells causes memory loss and cognitive decline. It is the most common type of dementia, accounting for around 60–80% of cases of dementia in the United States. Alzheimer’s disease affects around 5 million people in the US with estimates suggesting that this number will nearly triple by 2060.

Presentation details are:

• Title: A Regulatory T Cell Expansion Strategy to Target Inflammation in AD: Phase I feasibility trial
• Date: To Be Announced
• Conference: 2023 Keystone Symposia - Neurodegeneration: New Biology Guiding the Next Generation of Therapeutic Development (https://www.keystonesymposia.org/conferences/conference-listing/meeting?eventid=6922)

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 therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Coya’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination 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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