Coya Therapeutics Licenses Exclusive Worldwide rights to Exosome Engineering Technology (EET) from Carnegie Mellon University (CMU)

Rhea-AI Summary

Coya Therapeutics licenses exclusive rights to proprietary Exosome Engineering Technology, expanding potential applications and partnerships

Positive

• Coya Therapeutics has entered into an exclusive license for a next-generation EET platform, expanding their potential applications in neurodegenerative, autoimmune, and oncologic diseases.
• The patented technology overcomes known limitations of exosome manipulation and allows for the customization of exosome surfaces and loading of cargo.
• Data presented at a recent summit showed successful engineering of surface proteins on exosomes, increasing selective targeting to immune cells.

Negative

• None.

• Supported by promising data generated during the option period, Coya has entered into an exclusive license for a next-generation EET platform to enable engineering of exosomes with potential to target epitope driven neurodegenerative, autoimmune and oncologic diseases;
• Exosomes are a nanometer-sized type of extracellular vesicle that can be shed from every cell in the body- Researchers have attempted to harness the exosome as a drug delivery vehicle, but techniques previously developed required the use of complex molecular biology tools or degraded the exosome’s functionality;
• This patented technology requires no genetic modifications, overcomes known limitations of exosome manipulation, and also enables tethering proteins of interest to the exosome surface and loading cargo of interest within the exosome interior;
• Data was recently presented at the 5^th Exosome Based Therapeutic Development Summit successfully engineering a surface protein, cytotoxic T lymphocyte associated protein 4 (CTLA-4) on to Regulatory T cell (Treg) exosomes to increase selective targeting to immune cells;
• EET expands Coya’s optionality for potential non-dilutive business development and strategic partnerships with companies seeking innovative drug and RNA delivery platforms that may be selectively targeted to proteins or epitopes that drive disease.

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics and cell therapies intended to enhance the function of Tregs, today announced licensing of the exclusive, worldwide rights of a proprietary Exosome Engineering Technology from CMU with potential applications across multiple indications, including neurodegeneration, autoimmune, and oncology.

This technology is versatile, permitting the modification of exosomes from different biological sources while overcoming several of the scale-up and manufacturing challenges encountered with exosomes, including not requiring genetic manipulation. In addition, the ability to customize the surface of the exosome with a protein of interest while loading the interior of the exosome with cargo opens possibilities across multiple therapeutic areas beyond neurodegenerative diseases.

Data was recently presented at the 5^th Exosome Based Therapeutic Development Summit in Boston, MA on September 7, 2023, demonstrating that 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. CTLA-4-Treg exosomes dramatically increased targeting of, binding to, internalization of, and uptake into immune cells including macrophages and T cells. 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).

This novel proprietary EET platform extends Coya’s pipeline beyond Neurodegenerative disorders to include autoimmune disorders and cancer while expanding Coya’s optionality for potential non-dilutive business development and strategic partnerships with companies seeking novel ways to deliver cargo/drugs in a targeted fashion.

Fred Grossman, President and CMO said “The science behind the technology is strong and has focused on overcoming the limitations of exosomes. We believe this technology can shape the future of targeted delivery of desired agents to address multiple conditions.”

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 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.

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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.