Coya Therapeutics Successfully Engineers Regulatory T Cell (Treg) Derived Exosomes with CTLA-4 Protein to Selectively Target Immune Cells with Potential to Deliver Targeted Therapies Across Multiple Diseases

Rhea-AI Summary

Coya Therapeutics presents talk on Rapid Functionalization of Treg Exosomes for Targeted Immunotherapy at summit

Positive

• CTLA-4-engineered Treg exosomes increase targeting, binding, and uptake into immune cells
• Technology allows for engineering exosomes with proteins to treat autoimmune diseases and cancer
• Engineered exosomes have advantages like improved stability and enhanced targeted therapeutic response

Negative

• None.

• Using proprietary exosome tethering modification technology, Treg derived exosomes were engineered with a surface protein, cytotoxic T lymphocyte associated protein 4 (CTLA-4) to increase selective targeting to immune cells;
• This patented technology requires no genetic modifications, overcomes known limitations of exosome manipulation, and enables tethering of multiple potential proteins to an exosome surface and loading of therapeutic cargo in the exosome interior;
• CTLA-4-engineered Treg exosomes (CTLA-4-Treg exosomes) dramatically increased targeting of, binding to, internalization of, and uptake into immune cells including macrophages and T cells;
• This technology can serve as a platform to engineer the exosome surface with proteins of interest to target specific cell and tissue types to potentially treat epitope driven autoimmune diseases and cancer

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, including biologics and cell therapies, announced that Dr. Phil Campbell, Professor of Biomedical Engineering at CMU, presented his talk, “Rapid Functionalization of Treg Exosomes for Targeted Immunotherapy” at the 5^th Exosome Based Therapeutic Development Summit in Boston, MA this morning (September 7, 2023). The presentation can be accessed here.

Coya and CMU entered into a Research Collaboration Agreement and Option Agreement in 2022 to develop a unique patented technology intended to advance the potential use of exosomes for the treatment of diseases of unmet need.

In this study, it was demonstrated that by using a proprietary cholesterol DNA tether technology, Treg exosome membranes could be engineered to controllably immobilize CTLA-4, a membrane surface active protein, onto the Treg exosome surface resulting in stable CTLA-4-Treg exosomes. It was also demonstrated that CTLA-4-Treg exosomes exhibited far better cell uptake then non-modified Treg EVs in representative immune cells, macrophages (J7774 murine cell line) and T-cells (human Jurket cell line).

Previously, using the same technology, CMU demonstrated applications in Oncology by engineering mesenchymal derived exosomes with an immunomodulatory apoptotic inducing protein, Fas Ligand (FAS-L). The results demonstrate that targeted delivery of FASL-exosomes substantially increases its therapeutic effect with enhanced apoptosis in tumor cells and suppression of alloreactive T cells in mice, while minimizing potential off target effects. This publication is available here.

Tregs are important immunomodulatory cells, with a key role controlling inflammation, enabling self-tolerance, and promoting regenerative processes. Treg-derived exosomes share many of the properties of the parent Treg cells making them able to modulate physiological and pathophysiological processes. The proprietary technology generates Exosome Polymer Hybrids (EPHs) which allow for efficient and versatile method of engineering and customizing cargos of Treg-derived exosomes using oligonucleotide tethers. Delivering EPHs to sites of inflammation or epitopes that drive specific diseases, while delivering customized loads, enables the next generation of selectively targeted and potent Treg-derived exosomes.

Engineered exosomes may have multiple advantages, including low immunogenicity, improved stability, increased plasma retention after systemic delivery and increased residence time following local delivery, enhanced biodistribution, improved cell binding and uptake, and enhanced targeted therapeutic response.

Dr. Fred Grossman, President and Chief Medical Officer of Coya stated, “This proprietary technology expands Coya’s pipeline to include autoimmune disorders and cancer. These engineered exosomes are a cell - free drug delivery system without genetic modification that can travel throughout the body unimpeded, including through the blood brain barrier, to provide specific targeted therapies.”

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 proprietary investigational recombinant human low dose IL-2 biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a dual-mechanism investigational biologic combination comprised of proprietary low dose IL-2 and proprietary CTLA-4 Ig. The low dose IL-2 is intended to enhance anti-inflammatory regulatory T cell function and numbers while the fusion protein CTLA-4 Ig is intended to suppress pro-inflammatory cell function. These two mechanisms may be additive or synergistic in suppressing inflammation. 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 impact of COVID-19; 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/20230907917969/en/

Investor Contact

David Snyder

david@coyatherapeutics.com

Hayden IR

James Carbonara

(646)-755-7412

James@haydenir.com

Media Contact

Anna Marie Imbordino

annamarie@quantum-corp.com

917-680-8765

Source: Coya Therapeutics, Inc.