HCW Biologics Gets FDA Approval for Phase 1 Trial of HCW9302 for Alopecia

HCW Biologics Inc. (HCWB), a US-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend healthspan by targeting the link between chronic inflammation and disease, announced that it has received clearance of its Investigational New Drug Application (IND) from the US 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. Alopecia areata causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. HCW9302 is an injectable, first-in-kind interleukin 2 (IL-2) fusion protein complex constructed using the company’s proprietary TOBI platform technology. Its mechanism of action involves binding to IL-2aß? receptors predominantly expressed on regulatory T (Treg) cells, thereby activating and expanding Treg cells that can suppress unwanted immune and inflammatory responses.

Chronic inflammation is believed to be a significant contributing factor in many diseases and conditions including those that have a major impact on quality-of-life but are not life-threatening. In multiple relevant preclinical models, HCW9302 has shown efficacy in treating autoimmune diseases at well-tolerated dose levels by activating and expanding Treg cells through subcutaneous injections. Protein-based therapies, whether as direct inhibitors or immunomodulatory agents, have revolutionized the management of autoimmune and inflammatory conditions. The company believes that HCW9302, with its subcutaneous injectable approach, has the potential to activate and expand Treg cells in patients, reducing inflammation, while minimizing the risk of broad immunosuppression.

Dr. Hing C. Wong, founder and CEO of HCW Biologics, commented, “The FDA’s clearance to initiate our first-in-human clinical trial for HCW9302 brings us one step closer to advancing a potentially transformative immunotherapeutic treatment of autoimmune diseases. This trial is a milestone for our company, and the beginning of clinical development of treatments for quality-of-life indications. While not life-threatening, alopecia areata has no cure. Existing off-label treatments may provide some relief of symptoms, but there are often dangerous side effects. For those who suffer from this disease, it can negatively impact their quality-of-life.” Dr. Wong continued, “The goal of this initial trial is to establish the safe dose of HCW9302 that effectively increases Treg cells activity in patients. Once we achieve this objective, we will rapidly expand clinical development of HCW9302 in phase 2 studies in patients with other autoimmune diseases and inflammatory conditions, including other dermatological conditions, graft rejection, arthrosclerosis, diabetes, and neurodegenerative diseases where HCW9302 has been shown to have activity in relevant animal models.”

Alopecia areata (AA) is one of the most prevalent autoimmune diseases in the world, affecting approximately 1 in 1,000 people, with a lifetime incidence of 2% worldwide, or 160 million people. According to the National Alopecia Areata Foundation (NAAF), about 7 million people in the United States have alopecia areata. The condition primarily affects individuals under the age of 30, occurring at similar rates in both males and females. AA is characterized by hair loss in localized areas, the entire scalp, or, in some cases, the whole body. It occurs when the immune system mistakenly attacks hair follicles, leading to hair loss without causing permanent damage to the follicles. Patients often experience recurring episodes of hair loss throughout their lives. Existing treatments, such as corticosteroids, immunotherapy, Janus kinase inhibitors, and topical solutions, focus on managing the severity and duration of episodes of hair loss. However, these therapies primarily address symptoms rather than providing a cure or consistent, long-term hair regrowth. Currently, there is no cure for alopecia areata.

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