Coya Therapeutics Secures U.S. Patent for Recombinant Human Interleukin-2 Liquid Production Methods

Coya Therapeutics, Inc., a clinical-stage biotechnology company based in Houston, Texas, has made significant progress in its mission to advance treatments targeting systemic inflammation and neuroinflammation through innovative therapies. Recently, the company announced that the U.S. Patent and Trademark Office (USPTO) has granted them a new patent, numbered US 12,312,389 B2, which covers methods for producing highly stable liquid formulations of IL-2, specifically aldesleukin. This patent could pave the way for Coya's future developments in treating various conditions through both monotherapy and combination therapies.

Coya’s CEO, Arun Swaminathan, PhD, expressed enthusiasm about the patent's issuance, describing it as a vital milestone for the company. He emphasized that their investigational low-dose rhIL-2, known as COYA 301, is a critical asset within their development pipeline. Swaminathan highlighted the importance of this patent as part of a broader intellectual property portfolio that encompasses various combinations with other biologics, such as CTLA-4 Ig (COYA 302) and GLP-1 agonists (COYA 303). These combinations are designed to enhance the effectiveness of their therapies, offering a more robust protective barrier for their innovations.

This strategic move to secure patent protection strengthens Coya’s ability to explore diverse strategic and business development opportunities. The company is actively pursuing the expansion and enhancement of their patent portfolio with ongoing filings and prosecutions. The newly acquired patent is part of a growing intellectual property framework intended to support Coya’s investigational product candidates, including COYA 301, COYA 302, and COYA 303, though none are yet approved by the U.S. Food and Drug Administration.

Coya Therapeutics is committed to developing proprietary treatments that leverage the biology and therapeutic potential of regulatory T cells (Tregs). These Tregs are crucial for mitigating systemic inflammation and neuroinflammation, conditions often associated with dysfunctional Tregs. Such dysfunctions are linked to various neurodegenerative, metabolic, and autoimmune diseases, which can result in prolonged inflammation and oxidative stress, ultimately disrupting immune system homeostasis.

The pipeline of Coya’s investigational products is built on multiple therapeutic modalities that aim to restore the anti-inflammatory and immunomodulatory functions of Tregs. Their therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Each of these modalities forms a core part of Coya’s research and development efforts, showcasing their commitment to addressing complex diseases through cutting-edge therapies.

In addition to expanding their patent portfolio, Coya is advancing clinical studies. The company plans to submit an Investigational New Drug (IND) application for COYA 302, a proprietary combination of low-dose rhIL-2 and CTLA4-Ig. This submission is expected by the end of June, which will support the initiation of the Phase 2b study in patients with amyotrophic lateral sclerosis (ALS). This study is a testament to Coya’s ongoing efforts to translate their groundbreaking research into tangible therapeutic applications that can significantly impact patients' lives.

As Coya Therapeutics continues to make strides in the biotechnology sector, their focus remains on developing innovative treatments that harness the potential of regulatory T cells. With a robust pipeline and strategic patent acquisitions, the company is well-positioned to lead advancements in treating systemic inflammation and neuroinflammation, potentially offering relief to patients suffering from debilitating conditions.