Coya Therapeutics (“Coya”) Announces the Appointment of Dr. Merit Cudkowicz, M.D., M.Sc., as Clinical Advisor to Support the Development of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Rhea-AI Summary

Coya Therapeutics has engaged Dr. Merit Cudkowicz, a renowned neurologist and expert in ALS, as a clinical advisor. Dr. Cudkowicz will support the development of Coya's clinical asset, COYA 302, for the treatment of ALS. COYA 302 has shown positive clinical data in a small trial, halting disease progression and resulting in minimal decline over 12 months.

Positive

• Coya Therapeutics has engaged Dr. Merit Cudkowicz, a renowned neurologist and expert in ALS, as a clinical advisor.
• COYA 302, a dual-mechanism investigational biologic combination, has shown positive clinical data in a four-patient trial for the treatment of ALS.
• COYA 302 halted disease progression over 6 months and resulted in minimal decline over 12 months in patients with ALS.

Negative

• None.

• Dr. Merit Cudkowicz is the Director of the Sean M. Healey & AMG Center for ALS, Chief of Neurology at Mass General, Director and the Julieanne Dorn Professor of Neurology at Harvard Medical School.
• Dr. Cudkowicz’s research and clinical activities are dedicated to the study and treatment of people with ALS; she is one of the founders and past Co-Chairs of the Northeast ALS Consortium (NEALS), a group of over 134 clinical sites in the United States, Canada, Europe and the Middle East dedicated to performing collaborative clinical trials and research in ALS.
• Dr. Cudkowicz will support the development of Coya’s most advanced clinical asset, COYA 302, a dual-mechanism investigational biologic combination comprised of low dose Interleukin-2 (ld-IL2) that is intended to enhance anti-inflammatory regulatory T cell function with a fusion protein (CTLA4-Ig) that is intended to suppress pro-inflammatory cell function.
• Coya previously reported positive clinical data for COYA 302 for the treatment of ALS in a four-patient, open-label investigator-initiated trial illustrating that treatment with LD-IL2 + CTLA4-Ig halted disease progression over 6 months, and resulted in minimal decline over 12 months, in a cohort of patients who were declining prior to study initiation at an average of -1.1 ALSFRS-R points per month.

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, today announced the engagement of Merit Cudkowicz, MD, MSc as expert clinical advisor. Dr. Cudkowicz is a world-renowned neurologist who has dedicated her career to improving the life of patients with ALS and other serious neurological conditions. Dr. Cudkowicz brings decades of experience supporting the development of new therapies for ALS.

Dr. Cudkowicz is Principal Investigator of the Clinical Coordination Center for the National Institute of Neurological Disorders and Stroke’s Neurology Network of Excellence in Clinical Trials (NeuroNEXT). Dr. Cudkowicz has launched the first platform trial initiative in ALS, the HEALEY ALS Platform Trial, a program that helps accelerate therapy development in ALS.

Dr. Cudkowicz received the American Academy of Neurology 2009 Sheila Essay ALS award, the 2017 Forbes Norris Award from the International MND Alliance, the 2017 Pinnacle Award from the Boston Chamber of Commerce and the 2019 Ray Adams American Neurological Association Award. A dedicated educator, Dr. Cudkowicz mentors many young neurologists in clinical investigation of ALS and related neurodegenerative disorders. Dr. Cudkowicz completed her undergraduate degree in chemical engineering at Massachusetts Institute of Technology and obtained a medical degree in the Health Science and Technology program of Harvard Medical School. She served her internship at Beth Israel Hospital in New York and her neurology residency and fellowship at Massachusetts General Hospital. She also obtained a master’s degree in Clinical Epidemiology from the Harvard School of Public Health.

Dr. Merit Cudkowicz commented: "I am happy to join Coya as a clinical advisor as they move COYA 302 into a well powered and designed clinical trial. COYA 302's dual mechanism of action in enhancing Treg function and dampening other pro-inflammatory pathways combined with their early clinical proof of concept data provides strong rationale to move forward as a therapeutic strategy in ALS."

"We are privileged to leverage Dr. Cudkowicz’s expertise in supporting our clinical plans to rapidly advance COYA 302 in patients with ALS,” added Fred Grossman, D.O., Coya’s President and Chief Medical Officer.

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 includes 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 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

Forward-Looking Statements

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Investor Contact

David Snyder

david@coyatherapeutics.com

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Media Contact

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Source: Coya Therapeutics, Inc.

FAQ

Who is Dr. Merit Cudkowicz?

Dr. Merit Cudkowicz is a world-renowned neurologist who has dedicated her career to improving the life of patients with ALS and other serious neurological conditions.

What is COYA 302?

COYA 302 is a dual-mechanism investigational biologic combination developed by Coya Therapeutics for the treatment of ALS.

What were the results of the four-patient trial for COYA 302?

The trial showed that treatment with COYA 302 halted disease progression over 6 months and resulted in minimal decline over 12 months in patients with ALS.

What is the role of Dr. Cudkowicz as a clinical advisor?

Dr. Cudkowicz will support the development of COYA 302 and provide her expertise in ALS therapy development.