FDA Clears HCW Biologics to Evaluate Its Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial

February 3, 2025

DENVER, Colo., Feb 03, 2025 (247marketnews.com)- HCW Biologics (NASDAQ:HCWB) announced that it received FDA clearance for its Investigational New Drug (IND) application to begin a Phase 1 clinical trial of its lead drug candidate, HCW9302, in patients with moderate-to-severe alopecia areata. Alopecia areata is an autoimmune disease that causes sudden hair loss, with no FDA-approved curative treatments currently available. HCW9302 is an injectable interleukin-2 (IL-2) fusion protein designed to activate and expand regulatory T (T reg) cells, which help suppress unwanted immune responses and inflammation.

Preclinical studies have shown that HCW9302 can effectively treat autoimmune diseases by expanding T reg cells without causing broad immunosuppression. The company believes that this targeted approach could offer a promising treatment option for alopecia areata and other autoimmune conditions, improving patients’ quality of life by reducing inflammation.

Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, “The FDA’s clearance to initiate our first-in-human clinical trial for HCW9302 brings us one step closer to advancing a potentially transformative immunotherapeutic treatment of autoimmune diseases. This trial is a milestone for our Company, and the beginning of clinical development of treatments for quality-of-life indications. While not life-threatening, alopecia areata has no cure. Existing off-label treatments may provide some relief of symptoms, but there are often dangerous side effects. For those who suffer from this disease, it can negatively impact their quality-of-life. The goal of this initial trial is to establish the safe dose of HCW9302 that effectively increases T reg cells activity in patients. Once we achieve this objective, we will rapidly expand clinical development of HCW9302 in Phase 2 studies in patients with other autoimmune diseases and inflammatory conditions, including other dermatological conditions, graft rejection, arthrosclerosis, diabetes, and neurodegenerative diseases where HCW9302 has been shown to have activity in relevant animal models.”

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