HCW Biologics Reports Positive Phase 1 Preliminary Results for HCW9302 in Alopecia Areata

2026-06-16SEC Filing 8-K (0001493152-26-028807)

On June 16, 2026, HCW Biologics announced positive preliminary data from the first two dose cohorts of its Phase 1 dose-escalation clinical trial evaluating HCW9302, an IL-2 based fusion immunotherapeutic, for the treatment of alopecia areata. In the second cohort (3 micrograms/kg), all three participants with mild alopecia showed a clinical response, defined as a β‰₯25% reduction in Severity of Alopecia Tool (SALT) scores at four and/or nine weeks following a single subcutaneous dose. The therapy was well-tolerated across both cohorts, with no dose-limiting toxicities, no incidences of capillary leak or cytokine release syndrome, and no increase in blood eosinophil countsβ€”side effects often associated with IL-2 treatments. Most adverse events were mild injection-site reactions. HCW9302 is designed to preferentially expand regulatory T (Treg) cells to reduce inflammation. The company is currently dosing the third cohort (8 micrograms/kg) and expects to establish a recommended Phase 2 dose by the end of 2026. Future plans include expanding studies into other autoimmune conditions like vitiligo, atopic dermatitis, and potentially ALS.

Ticker mentioned:HCWB