HCW Biologics Releases Preliminary Data for HCW9302 Clinical Trial

HCW Biologics announced a preliminary human data readout for the first two dose cohorts from its dose-escalating Phase 1 clinical trial of HCW9302, an IL-2 based fusion immunotherapeutic, in patients with alopecia areata. In the second dose cohort, comprised of patients who received a single subcutaneous dose of HCW9302 monotherapy of three micrograms/kg body weight, all three participants showed preliminary indications of improvement in Severity of Alopecia Tool scores. These three participants, all with mild alopecia, showed a greater than or equal to 25% reduction in SALT scores compared to baseline at four and/or nine weeks after dosing. Treatment of patients in the third dose cohort is underway and evaluation of correlative study endpoints is ongoing. All patients, including the first dose cohort at one microgram/kg body weight and the second dose cohort at three micrograms/kg body weight, received a single subcutaneous dose of HCW9302 monotherapy. There were no reported incidences of capillary leak or cytokine release syndromes associated with high dose intravenous IL-2 therapy. Additionally, HCW9302 treatment did not increase blood eosinophil counts, another serious side effect commonly associated with IL-2 therapy. All reported HCW9302 treatment emergent adverse events were mild in severity and self-limiting and resolved without medical intervention. The most common side effect was temporary injection-site reaction. These preliminary findings support the company's belief that HCW9302 has the potential to activate and expand regulatory T, or Treg, cells in patients, reducing inflammation, while minimizing the risk of broad immunosuppression or unwanted side effects caused by the activation of immune effector cells. For alopecia areata, the company believes that HCW9302 can suppress the hair-follicle killing activities of the auto-reactive immune cells by activating and expanding Treg cells.