HCW Biologics Inc. announced it has received clearance of its Investigational New Drug (IND) Application from the U.S. Food and Drug Administration (FDA). This clearance allows the company to initiate a first-in-human Phase 1 dose escalation clinical trial.
The trial will evaluate HCW9302, one of its lead drug candidates, in patients suffering from moderate-to-severe alopecia areata. Alopecia areata is a common autoimmune disease that currently lacks curative FDA-approved treatments.
HCW9302 is an injectable interleukin 2 (IL-2) fusion protein complex, developed using the company's proprietary TOBI platform technology. Its mechanism involves activating and expanding T regulatory (T reg) cells to suppress unwanted immune and inflammatory responses.
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