HCW Biologics HCW9302 Phase 1: All 3 patients show positive response
HCW Biologics announced positive preliminary human data from the first two dose cohorts of its Phase 1 clinical trial for HCW9302 in patients with alopecia areata. All three participants in the second dose cohort (3 micrograms/kg) showed preliminary indications of improvement with a ">=25%" reduction in SALT scores. The IL-2 based fusion immunotherapeutic was well tolerated, with no dose-limiting toxicities or significant adverse effects. The company projects to establish the Recommended Phase 2 Dose by year-end 2026 and plans to explore multi-dose studies and other autoimmune indications.
Key Highlights
- HCW9302 Phase 1 trial for alopecia areata showed positive preliminary data.
- All 3 participants in 3 micrograms/kg cohort had ">=25%" SALT score reduction.
- Treatment was well tolerated; no dose-limiting toxicities or severe adverse effects.
- No capillary leak, cytokine release syndrome, or increased eosinophil counts reported.
- Company expects to establish Recommended Phase 2 Dose by year-end 2026.
- Third dose cohort (8 micrograms/kg) treatment is currently underway.
- Potential Phase 2 expansion to vitiligo, atopic dermatitis, and ALS.
Price Impact
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