HCW Biologics Inc. has commenced its first‑in‑human clinical trial of HCW9302, a novel interleukin‑2 (IL‑2) fusion protein designed to expand regulatory T‑cells (T₍reg₎) for the treatment of autoimmune diseases. The company said that dosing of the first cohort has been completed and the trial is actively enrolling multiple dose levels. This milestone follows prior clearance from the U.S. Food and Drug Administration to initiate the trial in patients with moderate‑to‑severe autoimmunity.
HCW9302 harnesses the company’s proprietary TOBI™ platform and functions via selective binding to IL‑2αβγ receptors, aiming to activate T₍reg₎ cells which play a key role in balancing immune responses and reducing chronic inflammation. Preclinical data highlighted improved pharmacokinetics—longer serum half‑life—and potent T₍reg₎ activation, positioning the molecule as a unique immunomodulator with potential across multiple autoimmune and inflammatory indications.
The Phase 1 dose‑escalation study will assess safety, tolerability and biomarker responses, including changes in T₍reg₎ cell populations and immune modulation. HCW Biologics plans to use results from this trial to support expansion into Phase 2, targeting other autoimmune diseases, dermatological indications and potentially neuroinflammatory conditions. The company said this trial initiation is a core element of its strategic shift toward licensed immunotherapies designed to extend health‑span by addressing chronic inflammation.
