First Patient Dosed at The Ohio State University Wexner Medical Center in this Multi-Center Trial

Active component of HCW9302 is interleukin-2 -- cytokine that maintains proper numbers and functions of regulatory T cells to control excessive inflammation

Gateway to development of a first-in-kind immunotherapeutic for autoimmune and pro-inflammatory diseases

 HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-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 the first patient was dosed at The Ohio State University Wexner Medical Center for the Company-sponsored, multi-center first-in-human clinical trial to evaluate HCW9302 in patients with alopecia areata (NCT07049328). This marks a major milestone in the Company’s clinical development program in autoimmune diseases.

HCW9302 is the Company’s lead product candidate for its clinical program to develop treatments for autoimmune diseases and inflammatory conditions. It is a subcutaneously injectable, first-in-kind interleukin-2 (“IL-2”) fusion molecule constructed using the Company’s legacy TOBI™ platform technology. IL-2, the active component of HCW9302, is the cytokine in humans and other vertebrates responsible for maintaining the proper numbers and functions of regulatory T (“T_reg”) cells in the body. T_reg cells control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases. The breakthrough discovery of the critical function of T_reg cells by Drs. Mary E. Brunkow, Fred Ramsdell and Shimon Sakaguchi was recently acknowledged with the 2025 Nobel Prize in Physiology or Medicine for their groundbreaking work which was the discovery that T_reg cells are the immune system’s security guards which prevent immune cells from attacking our own body.

The Company believes that HCW9302 has the potential to activate and expand T_reg 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 T_reg cells. There is no curative FDA approved treatments of this indication. Alopecia areata causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. The National Alopecia Areata Foundation estimates approximately 160 million people worldwide and 7 million people in the United States have alopecia areata. The condition affects about 2% of the global population at some point in their lifetime. 

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 T_reg 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.”

The Phase 1 multi-center dose-escalation study of HCW9302is designed to treat up to 30 patients with alopecia areata. The primary objectives of the study are to evaluate the safety of HCW9302, injected under the skin (subcutaneously), and to determine the recommended dose level to advance to later phase clinical studies. Secondary objectives include assessment of disease responses and the effects of HCW9302 on proliferation and function of immune cells, particularly T_reg cells. Depending on the results of this study, multi-dose studies of HCW9302 in expanded cohorts of patients with alopecia areata and in patients with other inflammatory dermatological conditions are expected to be initiated.