Coya Therapeutics Announces Pipeline Expansion - COYA 303: COYA 301 in Combination with GLP-1 Receptor Agonist for the Treatment of Inflammatory Diseases

Rhea-AI Summary

Coya Therapeutics (NASDAQ: COYA) has announced the expansion of its pipeline with COYA 303, a combination therapy of COYA 301 and GLP-1 receptor agonist for treating inflammatory diseases. COYA 303 is designed for subcutaneous administration and has shown promising results in preclinical studies with a dual immunomodulatory mechanism of action.

The company plans to publish the preclinical study results in a peer-reviewed publication in first half of 2025. The study demonstrated an additive/synergistic anti-inflammatory effect through increased Treg function and suppressed pro-inflammatory myeloid cells. Coya has filed several patent applications for the compound and is initiating translational studies with a major academic university.

The company aims to advance COYA 303 through IND-enabling studies alongside a strategic partner, focusing on neurodegenerative and autoimmune diseases.

Positive

• Preclinical studies showed promising dual immunomodulatory mechanism of action
• Multiple patent applications filed to protect COYA 303
• Partnership established with major academic university for translational studies

Negative

• Results publication delayed until 1H 2025
• Strategic partner required for further development
• Early-stage development with no clinical trials yet

Insights

Biotech Research Analyst

This pipeline expansion represents an intriguing strategic move into the lucrative GLP-1 space, but with a novel immunological twist. COYA 303's combination approach of low-dose IL-2 (COYA 301) with GLP-1 receptor agonists targets a compelling biological intersection between metabolic and immune pathways that hasn't been fully explored by current market players.

The preclinical data suggesting additive/synergistic anti-inflammatory effects through dual immunomodulation (enhanced Tregs and suppressed inflammatory cells) could differentiate this asset from standalone GLP-1 treatments. However, the market cap of $89.9M suggests investors remain cautious given the early stage and need for a strategic partner.

Key near-term catalysts include:

• Peer-reviewed publication in 1H 2025
• Potential strategic partnership announcement
• IND-enabling study initiation

The emphasis on seeking a strategic partner is prudent given the significant capital requirements for clinical development, though this may result in value sharing with a larger player.

Immunology Expert

The scientific rationale behind COYA 303 is sophisticated and mechanistically sound. The combination leverages two complementary pathways: IL-2's well-documented role in Treg expansion/activation and GLP-1's emerging anti-inflammatory properties. This dual approach could potentially create a more robust and sustained anti-inflammatory effect compared to either agent alone.

Think of it like a symphony - IL-2 conducts the regulatory T cells while GLP-1 helps quiet the inflammatory orchestra. The reported synergistic effects suggest these mechanisms aren't just additive but may actually amplify each other's benefits. For non-experts, imagine having both a shield (enhanced Tregs) and a dampener (reduced inflammation) working together to protect against autoimmune attacks.

The partnership with a major academic institution for translational studies adds credibility and could accelerate development by providing deeper mechanistic insights. However, success will ultimately depend on whether this elegant immunological hypothesis translates into meaningful clinical benefits.

Preclinical study anticipated to be published in 1H 2025 documenting combination’s additive and/or synergistic anti-inflammatory signal;

Company will seek to advance asset in neurodegenerative and autoimmune diseases through the next stages alongside a strategic partner

HOUSTON--(BUSINESS WIRE)-- 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 the expansion of its investigational pipeline and advancement of COYA 303 for the treatment of inflammatory diseases. Sustained inflammatory responses driven by dysfunctional immune regulation is a hallmark of serious autoimmune and neurodegenerative diseases.

COYA 303 is an investigational biologic combination of COYA 301 and a glucagon-like-peptide-1 receptor agonist (GLP-1 RA) designed for subcutaneous administration. In a preclinical study, COYA 303 exhibited a dual immunomodulatory mechanism of action resulting in an additive/synergistic anti-inflammatory effect, which the Company believes was due to increased Treg function and suppressed pro-inflammatory myeloid cells and responder T cells. Coya intends to publish the results of this study in a peer-reviewed publication in the first half of 2025 and has filed several patent applications to protect the compound.

COYA 301 is the Company’s proprietary low-dose IL-2 that serves as a backbone adjuvant with standard of care agents and other novel pathways.

Following the positive results of this study, Coya intends to continue ongoing strategic discussions to advance COYA 303 through IND-enabling studies and into the clinic. In support of these efforts, Coya is initiating translational studies in partnership with a major academic university.

“COYA 303 is the most recent addition to Coya’s investigational pipeline. We believe that while GLP-1 RAs may have monotherapy benefits in reducing inflammation, the unique anti-inflammatory signature of the combination of GLP-1 RA and COYA 301 is supportive of opportunities that may generate significant shareholder value for Coya and a potential strategic partner,” stated COYA CEO Arun Swaminathan.

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 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 302 – the Company’s lead biologic investigational product or “Pipeline in a Product”– is a proprietary combination of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease. Its multi-targeted approach enhances the number and anti-inflammatory function of Tregs and simultaneously lowers the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone.

For more information about Coya, please visit www.coyatherapeutics.com

Forward-Looking Statements

This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the clinical development and/or commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; ; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250121304839/en/

Investor

David Snyder, CFO

david@coyatherapeutics.com



CORE IR

Bret Shapiro

brets@coreir.com

561-479-8566



Media

For Coya Therapeutics:

Kati Waldenburg

media@coyatherapeutics.com

212-655-0924

Source: Coya Therapeutics, Inc.

FAQ

What is COYA 303 and how does it differ from existing COYA treatments?

COYA 303 is a combination of COYA 301 (low-dose IL-2) and GLP-1 receptor agonist, designed for subcutaneous administration. It features a dual immunomodulatory mechanism targeting inflammatory diseases through enhanced Treg function and suppressed pro-inflammatory cells.

When will Coya Therapeutics (COYA) publish the COYA 303 preclinical study results?

Coya Therapeutics plans to publish the preclinical study results in a peer-reviewed publication during the first half of 2025.

What therapeutic areas is COYA targeting with COYA 303?

COYA 303 is being developed for the treatment of inflammatory diseases, specifically targeting neurodegenerative and autoimmune diseases.

What are the next development steps for COYA 303?

Coya plans to advance COYA 303 through IND-enabling studies and into clinical trials alongside a strategic partner, while conducting translational studies with a major academic university.