• 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 / Sep 22, 2023 / 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

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