Coya Therapeutics Files New U.S. Patents for COYA 301 with GLP-1 Receptor Agonists

Coya Therapeutics, Inc., a clinical-stage biotechnology firm listed on NASDAQ as COYA, has taken significant steps to bolster its intellectual property portfolio. The company recently announced the filing of intellectual property protection for the combination of COYA 301, a recombinant human low-dose interleukin-2 (LD IL-2), and Glucagon-Like Peptide-1 receptor agonists (GLP-1 RAs).

Dr. Arun Swaminathan, Chief Business Officer of Coya, highlighted the growing interest from major pharmaceutical companies in expanding their GLP-1 RA pipeline through combination therapies. He noted that combining low-dose IL-2 with GLP-1 RAs could offer a novel approach to addressing multiple conditions, including neurodegenerative diseases like Alzheimer’s Disease, where GLP-1 RAs have shown promise. Swaminathan believes that this proprietary combination could pave the way for valuable business development partnerships.

GLP-1 RAs have already seen substantial commercial success in treating diabetes and obesity due to their glucose-lowering benefits, which are partly attributed to their anti-inflammatory and antioxidant properties. The potential to enhance these benefits by combining them with LD IL-2, which boosts Treg function, presents a significant opportunity. This multi-targeted therapeutic approach could address unmet needs for patients with severe systemic and neuro-inflammatory conditions, autoimmune disorders, and metabolic diseases.

LD IL-2 serves as a cytokine that enhances Treg function, thereby suppressing inflammatory responses. Concurrently, GLP-1 RAs offer neuroprotective and anti-inflammatory effects by modulating microglial activity, reducing oxidative stress, and promoting neuronal survival. Coya is actively investigating these combinations to potentially offer an optimized therapeutic solution for various diseases.

Dr. Howard Berman, CEO of Coya, emphasized that combination immunotherapy approaches are likely to become crucial in treating complex immune-based diseases driven by multiple pathological mechanisms. The COYA 301/GLP-1 RA combination targets multiple, independent immune pathways simultaneously, aligning with Coya's research and development strategy. This strategy includes the COYA 302, which combines COYA 301 with CTLA-4 Ig, also known as Abatacept, and is being evaluated for numerous neurodegenerative diseases like Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s, and Parkinson’s Diseases. Coya aims to expand its portfolio further with additional synergistic drug combinations involving COYA 301.

COYA 301 is Coya’s own investigational low-dose IL-2 aimed at enhancing the anti-inflammatory function of regulatory T cells (Tregs) and is designed for subcutaneous administration. COYA 302, on the other hand, is a combination therapy that includes low-dose IL-2 and CTLA-4 Ig. It is intended to enhance Treg function and suppress inflammation produced by activated monocytes and macrophages.

In February 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 group of ALS patients. The study, conducted at the Houston Methodist Research Institute, showed that the investigational treatment was well tolerated over a 48-week period with no serious adverse events reported. This study was the first of its kind to evaluate this dual-mechanism immunotherapy for ALS treatment.

Patients were monitored using the ALS Functional Rating Scale-Revised (ALSFRS-R), and the results suggested significant amelioration in disease progression over the 48-week treatment period. Additionally, Treg suppressive function, indicative of the percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase during the treatment period.

Coya Therapeutics, headquartered in Houston, Texas, focuses on developing proprietary treatments aimed at enhancing the function of regulatory T cells (Tregs) to address systemic inflammation and neuroinflammation. The company’s pipeline leverages multiple therapeutic modalities to restore Treg function, including Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.

COYA 302, Coya’s lead investigational product, combines COYA 301 and CTLA4-Ig for treating ALS, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease. This combination aims to enhance the anti-inflammatory function of Tregs and reduce pro-inflammatory mediators, potentially re-establishing immune balance and ameliorating inflammation.

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