HCW Biologics Doses First Patient in Phase 1 Trial of Treg-Activating HCW9302 For Alopecia Areata

HCW Biologics announced a key milestone with the first patient dosed in its Company-sponsored, first-in-human Phase 1 clinical trial of HCW9302 for alopecia areata at The Ohio State University Wexner Medical Center. The trial is part of a broader effort to advance therapies that target the link between chronic inflammation and autoimmune disease. HCW9302 is the company’s lead candidate for autoimmune and inflammatory disorders, marking a significant step in its clinical development strategy.

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, commented, “While not life-threatening, alopecia areata has no cure. For those who suffer from the burden of this disease, it can severely impact a person's quality of life and self-esteem, leading to increased rates of anxiety and depression. Existing off-label treatments may provide some relief of symptoms, but there are often dangerous side effects. HCW9302, a novel IL-2 based fusion molecule, has been demonstrated to be well tolerated in non-human primate studies, which is an important improvement compared to conventional IL-2 therapies. We are excited to be the sponsor of this clinical study to evaluate this promising new treatment for alopecia areata.”

Dr. Wong continued, “The goal of this initial trial is to establish the safe recommended Phase 2 dose of HCW9302 that effectively increases Treg cell activity in patients. Once we achieve this objective, we hope to rapidly expand clinical development of HCW9302 in Phase 2 studies in patients in alopecia areata as well as other autoimmune diseases and inflammatory dermatological conditions, such as vitiligo and atopic dermatitis. Additionally, we plan to explore the potential benefit that HCW9302 may have in a wide variety of inflammatory conditions, such as graft vs. host disease and neurodegenerative diseases, such as Alzheimer’s Disease, where HCW9302 has been shown to have activity in relevant animal models.”

HCW9302 is a subcutaneous, first-in-class IL-2 fusion molecule built using HCW’s TOBI™ platform. The therapy is designed to activate and expand regulatory T cells (Tregs), which naturally suppress excessive immune activity and inflammation. This mechanism is rooted in Nobel Prize–winning science recognizing Tregs as critical regulators that prevent the immune system from attacking the body. HCW Biologics believes that HCW9302 can counteract the immune-driven follicle destruction seen in alopecia areata without inducing broad immunosuppression.

The Phase 1 dose-escalation study will enroll up to 30 patients and aims to determine HCW9302’s safety, subcutaneous dosing levels, and early biological effects. Secondary assessments will measure disease response and the therapy’s influence on Treg proliferation and function. If the results are favorable, HCW Biologics intends to advance into multi-dose studies in larger alopecia cohorts and explore potential applications of HCW9302 in other inflammatory skin conditions.