Coya Therapeutics Expands Research Partnership with Houston Methodist

Coya Therapeutics, Inc. (NASDAQ: COYA), a company dedicated to advancing biologics to enhance regulatory T cell (Treg) function, has announced an expansion of its partnership with the Houston Methodist Research Institute (HMRI). This collaboration, under a sponsored research agreement (SRA), focuses on advancing proprietary Treg exosome technology towards first-in-human clinical studies, validating biomarkers across various neurodegenerative diseases, and exploring novel drug combinations with COYA 301, a proprietary low dose interleukin-2 (LD IL-2).

The Johnson Center for Cellular Therapeutics will fund the development and production of exosomes derived from patients' regulatory T cells. This initiative will see participation from Coya's SRA to Dr. Stanley Appel, Director of the Johnson Center and Chair of Coya’s Scientific Advisory Board. The collaborative effort aims to fully characterize these nanovesicles and establish Good Manufacturing Practice (GMP) production standards, paving the way for initial human trials.

In addition to exosome development, Coya and HMRI will focus on the characterization and validation of clinical biomarkers in patients suffering from Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s Disease, Frontotemporal Dementia (FTD), and Parkinson’s Disease (PD). These biomarkers are crucial for objectively correlating disease status with biological processes, improving clinical study criteria, and gauging treatment responses.

Moreover, Coya and HMRI will continue evaluating COYA 301's potential synergy with other drug products. Following the innovative approach seen in COYA 302, which combines LD IL-2 with CTLA4-Ig to target multiple pathways involved in neurodegenerative and autoimmune diseases, the company hopes to uncover new therapeutic possibilities. This biologic combination strategy forms the basis of Coya's unique approach to addressing complex disease pathophysiology and opens up avenues for future collaborations.

COYA 301, Coya’s proprietary LD IL-2, is designed to enhance the anti-inflammatory role of Tregs through subcutaneous administration. Meanwhile, COYA 302 is a dual immunomodulatory therapy combining LD IL-2 and CTLA4-Ig, targeting ALS, FTD, and PD. This combination aims to bolster Treg function and suppress inflammation caused by activated monocytes and macrophages.

In a proof-of-concept study conducted in February 2023, Coya reported results from an open-label clinical trial evaluating LD IL-2 and CTLA-4 Ig in patients with ALS at HMRI. Dr. Stanley Appel, Dr. Jason Thonhoff, and Dr. David Beers conducted the study, which followed patients over 48 weeks. Participants were monitored for safety, tolerability, Treg function, oxidative stress, inflammation biomarkers, and clinical functioning using the ALSFRS-R scale.

The treatment was generally well tolerated, with mild injection-site reactions being the most common adverse event. There were no study discontinuations or serious adverse events reported. The ALSFRS-R scores showed no significant difference from baseline at weeks 24 and 48, indicating a notable stabilization in disease progression.

Treg suppressive function, measured by the inhibition percentage of proinflammatory T cell proliferation, showed a significant increase over the treatment period and was reduced after an 8-week washout. Additionally, serum biomarkers of inflammation and oxidative stress decreased, aligning with the enhanced Treg function observed. Full biomarker data evaluation is ongoing.

Coya Therapeutics, headquartered in Houston, TX, focuses on developing treatments that harness the therapeutic potential of regulatory T cells to combat systemic and neuroinflammation. Their pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy, with COYA 302 at the forefront. This lead product combines COYA 301 with CTLA4-Ig for treating neurodegenerative diseases, aiming to restore immune balance and reduce inflammation sustainably.