Coya Therapeutics Licenses Intellectual Property Rights for Use of Next Generation Immune Modulatory Biologics in Combination with COYA 301 to Enhance Regulatory T Cells (Tregs) in Inflammatory Diseases - Seite 2

Michael Dixon, Ph.D., President and CEO of UNeMed, noted, “This agreement with Coya can potentially bring new therapies to patients suffering from neurodegenerative conditions. Coya’s foundation and progress in low-dose IL-2 research makes them an ideal company to leverage our findings to date.”

About UNeMed Corporation

UNeMed Corporation is the technology transfer and commercialization office for the University of Nebraska Medical Center. UNeMed serves all UNMC researchers, faculty, and staff who develop new biomedical technology and inventions and strives to help bring those innovations to the marketplace. For more information, please visit www.UNeMed.com, email [e-mail], or call 402-559-2468.

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 CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS. 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 LD IL-2 and CTLA-4 Ig in a small cohort of patients with ALS conducted at the Houston Methodist Research Institute (Houston, Texas) by Stanley Appel, M.D., Jason Thonhoff, M.D., Ph.D., and David Beers, Ph.D. 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 (±SD) ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of treatment were not statistically different compared to the ALSFRS-R score at baseline (33.5 ±5.9), suggesting significant amelioration in the progression of the disease over the 48-week treatment period.