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

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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