• The academic proof-of-concept open-label study evaluated the biological activity, cytokine and chemokine blood biomarkers, safety, and preliminary efficacy of low-dose interleukin-2 (ld IL-2) in 8 patients with mild-to-moderate AD. The study was conducted by Dr. Appel and Dr. Faridar at the Houston Methodist Hospital.
• Coya’s investigational low-dose interleukin-2 (ld IL-2) for subcutaneous administration has been designed to enhance in vivo the anti-inflammatory function of regulatory T cells (Tregs).
• Treg dysfunction has been associated with increased neuroinflammation, which is observed in AD and other neurodegenerative diseases, and may contribute to disease severity and 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 subcutaneous ld IL-2 at the 2023 Alzheimer’s Association International Conference (AAIC) to be held in Amsterdam, Netherlands, from July 16-20, 2023.

The proof-of-concept open-label clinical study is the first-of-its-kind evaluating subcutaneous ld IL-2 immunotherapy for the treatment of AD. Patients in the study received investigational ld IL-2 treatment for 4 consecutive months and were evaluated for safety and tolerability, Treg function, blood biomarkers of inflammation, and clinical functioning as measured by the Clinical Dementia Rating (CDR), the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog), and the Mini-Mental State Examination (MMSE).

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.

The study was conducted by Stanley Appel, M.D. and Alireza Faridar, M.D. at the Houston Methodist Research Institute (Houston, Texas). 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.

Presentation details:

• Title: A Phase 1 Clinical Trial of IL-2 in Patients with Alzheimer’s Disease: A Regulatory T Cell Expansion Strategy Targeting Inflammation
• Date: July 16, 2023
• Conference: 2023 Alzheimer’s Association International Conference (aaic.alz.org)

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 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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