Coya Therapeutics Reports Progress from an Academic Supported First-in-Class Treg-derived Exosome Program

Rhea-AI Summary

Coya Therapeutics (NASDAQ: COYA) provided an update on its Treg-derived exosome platform development for treating systemic and neurodegenerative diseases. The company's research has shown that regulatory T cell-derived exosomes (Treg exosomes) effectively suppress inflammation in preclinical models.

Key developments include:

• Treg exosomes demonstrated strong therapeutic potential in suppressing inflammation in neurodegenerative disease models
• Initial engineering batches using healthy donor Tregs planned for Q1 2025
• GMP manufacturing of larger-scale clinical batches scheduled for Q4 2025
• Program funded by Johnson Center for Cellular Therapeutics, Hop On A Cure, and Energy Transfer

The company highlighted that Treg exosomes have advantages over Tregs as they target myeloid cells driving disease progression and resist conversion to non-suppressive phenotypes in inflammatory environments.

Positive

• Exclusive rights for clinical application of Treg exosome technology
• Program advancement without impact on company's cash runway
• Promising preclinical results showing disease progression slowdown and increased survival
• External funding secured from multiple partners

Negative

• No human clinical trials initiated yet
• Manufacturing process still in development phase
• Commercial production not expected until at least late 2025

Insights

Biotechnology Development Expert

Coya's progress with Treg-derived exosomes represents a significant technical advancement in their pipeline development. The completion of initial engineering batches in Q1 2025 using healthy donor Tregs marks a tangible step forward in manufacturing feasibility.

What makes this approach scientifically compelling is the unique advantage of exosomes over whole cells. Since these Treg exosomes are end-stage differentiated, they're less susceptible to the inflammatory microenvironment that can compromise function of whole-cell therapies. This addresses a key limitation in current cell therapy approaches for neurodegenerative diseases.

The preclinical evidence demonstrates impressive utility - intranasal administration showed disease progression slowing, survival increases, and CNS inflammation modulation in neurodegeneration mouse models. The targeted uptake by myeloid cells that drive disease progression is particularly promising.

The manufacturing timeline indicates GMP clinical batch production in Q4 2025, suggesting first-in-human studies likely in early 2026. While this positions the therapy firmly in early clinical development, the technical foundations appear robust.

What's particularly noteworthy is the ability to develop an allogeneic ("off-the-shelf") modality, which could ultimately provide manufacturing scale advantages over autologous approaches. The focus on reproducibility of manufacturing processes is crucial for regulatory success, showing appropriate development discipline.

Biotech Investment Analyst

This update reveals a strategically important pipeline advancement for Coya that enhances their platform value while preserving financial resources. The company has effectively leveraged external funding through partnerships with the Johnson Center, Hop On A Cure, and Energy Transfer to advance this program without impacting their cash runway - a critical consideration for clinical-stage biotechs.

The exclusive rights Coya maintains for clinical applications represents significant intellectual property value. Developing a potential first-in-class therapy for neurodegenerative diseases addresses substantial market opportunities with high unmet needs.

This exosome program complements Coya's existing pipeline, particularly COYA-302, creating platform synergies rather than competing for internal resources. The allogeneic ("off-the-shelf") approach could provide long-term production cost advantages and scalability compared to autologous cell therapies.

While revenue potential remains years away given the Q4 2025 target for GMP manufacturing followed by clinical trials, progression to human studies would represent a significant de-risking milestone. For investors, this demonstrates pipeline diversification while maintaining disciplined capital allocation.

The manufacturing progress itself serves as proof-of-concept for the platform's technical feasibility, potentially making Coya more attractive for future partnership opportunities with larger pharmaceutical companies looking to enter the neuroinflammation space.

Regulatory T cell-derived exosomes (Treg exosomes) have demonstrated strong and consistent therapeutic potential in suppressing inflammation in preclinical models of neurodegenerative diseases as previously published here

Treg exosomes are end-stage differentiated, making them less likely to be affected by pro-inflammatory factors that may impact their suppressive function

The work planned includes GMP processes and manufacturing activities and the production of larger-scale clinical batches in the fourth quarter of 2025, in preparation for a first in human study

Funded by the Johnson Center for Cellular Therapeutics, Hop On A Cure, and Energy Transfer, with Coya holding exclusive rights for clinical application

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, today provides a status update of its investigational regulatory T cell-derived exosome (Treg exosomes) platform intended for the treatment of systemic and neurodegenerative diseases driven by chronic inflammation. Sustained inflammatory responses driven by dysfunctional immune regulation is a hallmark of serious autoimmune and neurodegenerative diseases.

Fred Grossman, DO, Coya’s Chief Medical Officer commented: “Our Treg focused pipeline continues its advancement with the goal of manufacturing an allogeneic (off the shelf) specific modality that has the potential to be a first-in-class disease-modifying treatment for devastating neurodegenerative diseases of high unmet need. This approach complements and adds to our pipeline of therapies, including COYA-302, that aim to enhance Tregs and suppress neuroinflammation to slow progression in several neurodegenerative diseases.”

Arun Swaminathan, CEO of Coya, stated, “We believe Treg exosomes are complementary to and will provide accretive value to our biologics platform. Thanks to our partnership with Dr. Stanley Appel and the Johnson Center, the program is being advanced without impact to our cash runway.”

Coya’s previous research demonstrated that ex vivo expanded Treg exosomes express key immunoregulatory markers and effectively suppress pro-inflammatory responses in vitro. Treg exosomes are highly suppressive on pro-inflammatory macrophages and responder T cells. Additionally, Treg exosomes have advantages over Tregs in that they are taken up by myeloid cells that drive disease progression, and they are resistant to conversion to a non-suppressive phenotype in the deleterious inflammatory environment commonly observed in certain systemic and neurodegenerative diseases, since they are not cells. Consistent with the results of in vitro experiments, in a well-established mouse model of neurodegeneration, intranasal administration of these Treg exosomes has shown promising results, including slowing disease progression, increasing survival, and modulating inflammation within the CNS.

After the successful manufacturing in Q1 2025 of initial engineering batches using expanded Tregs from healthy donors, the Johnson Center is working on additional manufacturing runs to fully characterize the attributes and specifications of Treg exosomes and ensure the reproducibility of the manufacturing processes. Following the completion of these activities, the plans are to initiate GMP manufacturing of larger-scale clinical batches before the end of 2025.

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.

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

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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/20250326672064/en/

Investor Contact

David Snyder, CFO

david@coyatherapeutics.com

CORE IR

Bret Shapiro

brets@coreir.com

561-479-8566

Media Contacts

For Coya Therapeutics:

Kati Waldenburg

media@coyatherapeutics.com

212-655-0924

Source: Coya Therapeutics, Inc.

FAQ

What are the key milestones for COYA's Treg exosome program in 2025?

COYA plans initial engineering batches in Q1 2025 and GMP manufacturing of larger-scale clinical batches in Q4 2025, preparing for first-in-human studies.

How does COYA's Treg exosome technology differ from traditional Treg therapy?

Treg exosomes are more resistant to inflammatory environments and specifically target myeloid cells driving disease progression, unlike traditional Treg cells.

What preclinical results has COYA's Treg exosome therapy shown?

In mouse models, intranasal Treg exosomes showed promising results in slowing disease progression, increasing survival, and modulating CNS inflammation.

Who is funding COYA's Treg exosome development program?

The program is funded by the Johnson Center for Cellular Therapeutics, Hop On A Cure, and Energy Transfer, with Coya holding exclusive clinical rights.