Coya Therapeutics Reports Progress from an Academic Supported First-in-Class Treg-derived Exosome Program
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
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
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
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, those related to risks associated with 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 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/20250326672064/en/
Investor Contact
David
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.
