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HOUSTON - Coya Therapeutics, Inc. (NASDAQ:COYA), a clinical-stage biotech firm with a market capitalization of $89 million, has announced the issuance of a U.S. patent for its investigational liquid formulation of interleukin-2 (IL-2). The patent, granted by the U.S. Patent and Trademark Office (USPTO), covers methods for producing stable liquid formulations of IL-2, a therapeutic protein. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet.
The newly issued patent, identified as US 12,312,389 B2, is part of Coya’s strategy to strengthen its intellectual property portfolio, which includes a series of ongoing filings and prosecutions. This patent complements Coya’s growing collection of patents, which also covers combination therapies with other biologics.
Coya’s pipeline features investigational treatments such as COYA 301, a low-dose rhIL-2 therapy, and COYA 302, a combination therapy with CTLA-4 Ig, both aimed at addressing systemic inflammation and neuroinflammation. The company has exclusive in-vivo rights to the patent and related intellectual property for multiple indications, both as monotherapy and in combination with other treatments. Despite recent stock volatility, with shares down nearly 10% in the past week, analysts maintain an optimistic outlook with price targets ranging from $14 to $18. InvestingPro analysis suggests the stock is currently fairly valued, with additional insights available to subscribers.
Coya’s CEO, Arun Swaminathan, PhD, remarked on the significance of the patent, emphasizing its role in safeguarding the company’s therapeutic assets. According to the company’s timeline, Coya plans to submit an Investigational New Drug (IND) application for COYA 302 by the end of June, setting the stage for a Phase 2b study in patients with Amyotrophic Lateral Sclerosis (ALS).
The company, headquartered in Houston, TX, focuses on leveraging the biology of regulatory T cells (Tregs) to develop treatments for diseases characterized by inflammation and immune system imbalance. Its therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Financial metrics from InvestingPro indicate a current ratio of 8.84, reflecting strong liquidity, while analysts anticipate significant sales growth in the current fiscal year. Subscribers can access 5 additional ProTips and comprehensive financial analysis through the platform.
While COYA 301, COYA 302, and COYA 303 are investigational product candidates not yet approved by the U.S. Food and Drug Administration, the patent issuance represents a milestone for Coya as it continues to advance its clinical development.
This news is based on a press release statement from Coya Therapeutics, Inc.
In other recent news, Coya Therapeutics is advancing its platform for regulatory T cell-derived exosome treatments, targeting chronic inflammation associated with neurodegenerative diseases. The company has made significant progress in producing Treg exosomes, which have shown promise in preclinical models for suppressing inflammation. This development is backed by partnerships and funding from organizations such as Hop On A Cure and Energy Transfer. Additionally, Coya Therapeutics has completed initial engineering batches of Treg exosomes and plans to begin Good Manufacturing Practice manufacturing for larger-scale clinical batches by the end of 2025.
BTIG has reiterated its Buy rating on Coya Therapeutics with a $15 price target, emphasizing the potential of COYA-302, a treatment for amyotrophic lateral sclerosis (ALS). The ongoing discussions with the FDA are likely focused on the biological aspects of the therapy. COYA-302 has shown positive results in a Phase 1b ALS study, leading to stability in patients and increased T regulatory cell activity. The potential of another therapy, COYA-303, is also highlighted, which combines low-dose IL2 with a GLP-1 receptor agonist to address Alzheimer’s Disease. Insights from a recent Key Opinion Leader call support the potential efficacy of such anti-inflammatory therapeutics.
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