This open-label Phase 1 study measures safety, peripheral and central inflammation, effects on Treg cell populations, and FTD progression;

Five of the 8 planned FTD subjects have been enrolled to date;

Results of study will inform Coya’s randomized, double-blinded Phase 2 trial of COYA 302 in patients with FTD

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces that five of eight patients have been enrolled in the investigator-initiated academic study of LD IL-2 + CTLA4-Ig combination in patients with Frontotemporal Dementia (FTD). The study is being conducted by Drs. Stanley Appel and Alireza Faridar at Houston Methodist Hospital. Topline results of the study will be leveraged to inform and finalize the planned trial design of a Company-sponsored, randomized, double-blinded Phase 2 trial of COYA 302 in patients with FTD. Coya has been awarded $5 million by the Alzheimer’s Drug Discovery Foundation (ADDF) to support the development of COYA 302 in FTD.

The current investigator-initiated study is evaluating the effects of LD IL-2 + CTLA4-Ig on a variety of parameters in patients with FTD, including safety, tolerability, Treg cell populations, peripheral and central inflammation, and disease progression. COYA 302 is a proprietary formulation of this biologic combination therapy, comprised of low dose interleukin-2 (LD IL-2) and cytotoxic T lymphocyte-associated antigen 4 immunoglobulin fusion protein (CTLA4-Ig).

Fred Grossman D.O., President and CMO of Coya, stated, “We plan to submit an IND for FTD, and the data from the investigator-initiated study will inform some design features of this planned trial. COYA 302 has potential therapeutic application in a variety of neurodegenerative diseases, starting with ALS and FTD.”

Tregs are dysfunctional and compromised in patients with FTD, skewing the immune system toward a proinflammatory status and potentially contributing to disease progression. The combination of LD IL-2 + CTLA4-Ig is believed to have additive and/or synergistic effects on enhancing Treg cell populations and lowering peripheral/central inflammation.

Prior data presented by the investigators at the AD/PD 2024 Conference in March 2024 demonstrated that Treg suppressive function was significantly reduced in patients with FTD, compared to controls (p<0.01), demonstrating that Treg immunomodulatory function is negatively impacted in FTD and peripheral levels of inflammatory cytokines and chemokines are increased, supporting the critical role of the immune system in the pathophysiology of FTD. Treg dysfunction and increased levels of inflammatory cytokines and chemokines have been previously reported by Coya in other serious and progressive neurodegenerative diseases and support the multi-pathway combination approach of COYA 302 to target numerous components of the dysfunctional immune system.

About Frontotemporal Dementia

Frontotemporal dementia (FTD) is the result of damage to neurons in the frontal and temporal lobes of the brain. Many possible symptoms can result, including unusual behaviors, emotional problems, trouble communicating, difficulty with work, or difficulty with walking. FTD is rare and tends to occur at a younger age than other forms of dementia. About 60% of people with FTD are 45 to 64 years old. FTD is progressive, meaning symptoms get worse over time. In the early stages, people may have just one symptom. As the disease progresses, other symptoms appear as more parts of the brain are affected. It is difficult to predict how long someone with FTD will live. Some people live more than 10 years after diagnosis, while others live less than two years after they are diagnosed. There is no cure for FTD, and no treatments slow or stop the progression of the disease.¹

References

1. Atassi N, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology, 2014;83:1719–1725.

About COYA 302

COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 is comprised of proprietary low dose interleukin-2 (LD IL-2) and cytotoxic T lymphocyte-associated antigen 4 immunoglobulin fusion protein (CTLA4-Ig) and is being developed for subcutaneous administration for the treatment of patients with ALS, FTD, and Parkinson’s Diseases (PD). These mechanisms may have additive or synergistic effects.

In February of 2023, Coya announced results from a proof-of-concept, open-label clinical study evaluating commercially available LD IL-2 and CTLA-4 Ig in a small cohort of patients with ALS conducted at the Houston Methodist Research Institute (Houston, Texas). This study was the first-of-its-kind evaluating this dual-mechanism immunotherapy for the treatment of ALS. Patients in the study received investigational treatment for 48 consecutive weeks and were evaluated for safety and tolerability, Treg function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the ALSFRS-R scale.

During the 48-week treatment period, the therapy was well tolerated. The most common adverse event was mild injection-site reactions. No patient discontinued the study, and no deaths or other serious adverse events were reported.

Patients' disease progression was measured using the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in patients with ALS. The mean ALSFRS-R scores at week 24 and week 48 after initiation of treatment were not statistically different compared to the ALSFRS-R score at baseline, suggesting that disease progression was ameliorated over the 48-week treatment period. Treg suppressive function, expressed as percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the course of the treatment period and was significantly reduced at the end of the 8-week washout post-treatment period.

The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides. The available data up to 16 weeks after initiation of treatment suggested a decrease in these biomarker levels, which is consistent with the observed enhancement of Treg function. The evaluation of the full biomarker data is ongoing.

COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.

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.

COYA 302 – the Company’s lead biologic investigational product, or “Pipeline in a Product,” is a proprietary combination therapy consisting of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease. Its multi-targeted approach is designed to enhance the number and anti-inflammatory function of Tregs and simultaneously lower the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone.

For more information about Coya, please visit www.coyatherapeutics.com.

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