Coya Therapeutics, Inc. is a clinical-stage biotechnology company which engages in developing proprietary medicinal products to modulate the function of regulatory T cells. The company was founded by Howard Berman in 2020 and is headquartered in Houston, TX.
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2020
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- Coya Therapeutics published preclinical results for COYA 303, a combination of proprietary low-dose IL-2 and a GLP-1 receptor agonist, in the International Journal of Molecular Sciences. - In a subacute low-dose LPS mouse model, the combination produced complementary immunomodulatory effects compared with either low-dose IL-2 or GLP-1RA as monotherapy. - The GLP-1RA attenuated myeloid expansion and inflammatory transcriptional responses, while low-dose IL-2 increased regulatory T cell numbers and suppressive-function transcripts. - Coya said the findings support further evaluation of COYA 303 in Alzheimer's disease and other complex neurodegenerative indications, and it will pursue non-dilutive funding or partnerships.
- Health Canada has accepted Coya Therapeutics' Clinical Trial Application for COYA 302, allowing the company to initiate patient enrollment at Canadian ALS centers for the ALSTARS Trial. - The ALSTARS Trial is a Phase 2, randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy and safety of COYA 302 for amyotrophic lateral sclerosis treatment. - COYA 302 is an investigational biologic combination therapy comprising low-dose interleukin-2 and CTLA-4 Ig, designed to enhance regulatory T cell function and suppress inflammation in neurodegenerative diseases. - The expansion to Canadian sites is expected to enhance patient recruitment for the ongoing study, which is already underway in the United States.
- Coya Therapeutics completed a $23 million public offering to fund clinical development of its regulatory T cell-enhancing therapies for neurodegenerative disorders. - The company is currently conducting the ALSTARS Trial, a Phase 2 study evaluating COYA 302 for ALS treatment using a dual immunomodulatory approach. - COYA 302 combines low-dose interleukin-2 and CTLA-4 Ig to enhance anti-inflammatory Treg function and suppress monocyte-macrophage inflammation. - The funding will support working capital and general corporate purposes, including advancement of the company's clinical development pipeline.
- Coya Therapeutics has completed enrollment of 9 patients in an investigator-initiated study testing low-dose IL-2 and CTLA4-Ig combination therapy for frontotemporal dementia. - The proof-of-concept study follows positive interim results from 5 patients announced in April 2025, with no serious adverse events reported to date. - Study completion is anticipated in Q4 2025, targeting a devastating neurodegenerative disease affecting approximately 30,000 Americans with limited treatment options.
- Coya Therapeutics is awaiting FDA decision on its IND application for COYA 302, a dual immunomodulatory therapy targeting ALS, with a decision anticipated by the end of August. - The company reported $29.8 million in cash reserves but saw collaboration revenues drop significantly from $3.4 million to $0.2 million in Q2 2025. - COYA 302 combines low-dose interleukin-2 and CTLA-4 Ig to enhance regulatory T cell function and suppress inflammation in neurodegenerative diseases. - The company plans to submit an IND for frontotemporal dementia (FTD) by year-end and has filed a $75 million mixed shelf offering for future financing.
- Coya Therapeutics' COYA 303, a combination of low-dose IL-2 and GLP-1 receptor agonist, showed significant anti-inflammatory effects in brain regions and enhanced regulatory T cell function in a preclinical mouse model. - The investigational therapy demonstrated attenuation of neuroinflammation in cortex and hippocampus regions while reducing pro-inflammatory myeloid cells and associated cytokines compared to untreated animals. - Results support COYA 303's potential for treating Alzheimer's disease and other neurodegenerative conditions driven by chronic inflammation, with additional cohorts underway to optimize treatment protocols.
- Coya Therapeutics received U.S. Patent 12,312,389 B2 covering methods for producing highly stable liquid formulations of IL-2 (aldesleukin), strengthening its intellectual property portfolio. - The company plans to submit an IND for COYA 302, combining low-dose rhIL-2 with CTLA4-Ig, by the end of June to initiate a Phase 2b study in ALS patients. - Coya's therapeutic pipeline focuses on regulatory T cell biology to target systemic inflammation and neuroinflammation across neurodegenerative, metabolic, and autoimmune diseases. - The patent protection enhances Coya's strategic positioning as it continues expanding its rhIL-2 and combination therapy intellectual property portfolio.
- Coya Therapeutics is advancing its regulatory T cell-derived exosome (Treg exosome) platform with plans to initiate GMP manufacturing of clinical batches by Q4 2025, positioning it for first-in-human trials. - Preclinical research demonstrates Treg exosomes effectively suppress pro-inflammatory responses, with intranasal administration in mouse models showing promising results in slowing disease progression and increasing survival. - The Treg exosome platform complements Coya's existing pipeline, including COYA-302, targeting the $59 billion neurodegenerative disease market that is expected to reach $83 billion by 2030.
- Coya Therapeutics is set to initiate a Phase 2b trial for Coya-302 in 2025, an innovative approach to treating amyotrophic lateral sclerosis (ALS) by enhancing regulatory T cells (Tregs). - Coya-302 aims to reduce neuroinflammation, a key factor in ALS progression, potentially slowing down the disease via a combination therapy approach. - With recent financial backing and a commercialization partnership with Dr. Reddy’s, Coya is well-positioned to advance its pipeline and address the significant unmet need in the ALS market. - Coya's broader pipeline includes preclinical Treg-based therapies for Alzheimer’s and Parkinson’s diseases, highlighting its focus on addressing neuroinflammation across multiple neurodegenerative conditions.
- Coya Therapeutics reports that five of eight planned patients have been enrolled in a Phase 1 study evaluating low-dose IL-2 and CTLA4-Ig combination for frontotemporal dementia (FTD). - The open-label study assesses the safety, tolerability, impact on Treg cells, and effects on inflammation in the brain and periphery in FTD patients. - Data from this investigator-initiated study will inform the design of Coya's Phase 2 trial of COYA 302, a proprietary formulation of the LD IL-2 + CTLA4-Ig combination. - Prior data showed Treg suppressive function was significantly reduced in patients with FTD, compared to controls (p<0.01), demonstrating that Treg immunomodulatory function is negatively impacted in FTD.
