HCW Biologics receives clearance of IND from FDA for HCW9302

HCW Biologics (HCWB) announced that it has received clearance of its Investigational New Drug Application, IND, from the U.S. Food and Drug Administration, FDA, to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. HCW9302 is an injectable, first-in-kind interleukin 2 fusion protein complex constructed using the Company’s proprietary TOBI platform technology. Its mechanism of action involves binding to IL-2alphabetagamma receptors predominantly expressed on regulatory T cells, thereby activating and expanding Treg cells that can suppress unwanted immune and inflammatory responses.