Coya Therapeutics has secured a significant intellectual property milestone with the issuance of U.S. Patent 12,312,389 B2, which covers methods of producing highly stable liquid formulations of IL-2 (aldesleukin). The Houston-based clinical-stage biotechnology company announced that through an existing agreement, it holds exclusive in-vivo rights to this patent and related intellectual property spanning multiple indications for both monotherapy and combination therapies.
The patent protection comes as Coya prepares to advance its lead combination therapy into clinical trials. The company is on track to submit an Investigational New Drug (IND) application for COYA 302 by the end of June, supporting the initiation of a Phase 2b study in patients with amyotrophic lateral sclerosis (ALS). COYA 302 represents a proprietary combination of low-dose recombinant human IL-2 (rhIL-2) and CTLA4-Ig.
Strategic IP Portfolio Expansion
"The issuance of this in-licensed patent sets a strong milestone in the history of Coya," said Arun Swaminathan, PhD, CEO of Coya Therapeutics. "Our investigational low-dose rhIL-2 (COYA 301) is a key asset of Coya's pipeline. This patent serves as only one component of a growing, broader, and layered IP portfolio involving combinations with other biologics – such as Coya's combinations with CTLA-4 Ig (COYA 302) and GLP-1 agonists (COYA 303) that we believe, adds a broader moat of protection to the portfolio."
The company and its partners are continuing to broaden and expand their rhIL-2 and rhIL-2 combination patent portfolio through ongoing filings and prosecutions. This strategic approach aims to create comprehensive intellectual property protection around Coya's therapeutic platforms.
Regulatory T Cell-Focused Pipeline
Coya Therapeutics is developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (Tregs) to target systemic inflammation and neuroinflammation. According to the company, 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.
The company'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.
Clinical Development Timeline
COYA 301, COYA 302, and COYA 303 are each investigational product candidates not yet approved by the U.S. Food and Drug Administration. The ready-to-use liquid formulation of IL-2 covered by the new patent represents a key component of Coya's investigational pipeline, with the company positioning the patent protection to strengthen its strategic and business development optionality.
The upcoming IND submission for COYA 302 marks a critical regulatory milestone as Coya advances its combination therapy approach targeting ALS patients. The Phase 2b study will evaluate the safety and efficacy of the low-dose rhIL-2 and CTLA4-Ig combination in this patient population.
