Towards Healthcare

HCW to begin with a measurable First-In-Human Clinical Trial focusing on Autoimmune Disease

HCW Biologics announced the first patient dose in its Phase 1 clinical trial of HCW9302, a new IL-2-based immunotherapy designed to treat alopecia areata by boosting Treg cells and reducing inflammation.

Category: Science Published Date: 21 November 2025
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Announcement

HCW Biologics Inc., a US-based clinical-level biopharmaceutical company aimed at establishing and exploring new innovative immunotherapies to expand healthspan by focusing on the connection between chronic disease and inflammation, proudly declared its dosage completion on the first patient at the Ohio State University Wexner Medical Center. As the company promoted various center in a first-in-human clinical trial to examine HCW9302 in alopecia areata patients (NCT07049328). This is a key milestone in the HCW’s clinical development initiative in autoimmune diseases.

The company’s potential, serving the healthcare sector

The HCW9302 is the HCW’s well-known product candidate, the best choice for its clinical program to establish treatments for inflammatory conditions and autoimmune diseases. It is a hypodermically injectable and best interleukin-2 (IL-2) fusion molecule built with the help of the Company’s pride, TOBI™ platform technology. HCW9302’s active component IL-2 is the cytokine in different vertebrates and humans that balances the accurate functions and numbers of regulatory T (Treg) cells.

The company have confidence that HCW9302 will be a capable candidate to extend and activate the Treg cells in the patient group, alleviating inflammation. Alongside, mitigating the unfavourable scenario of vast immunosuppression or unwelcomed side effects provoked by the activation of immune effector cells. The company also feels that HCW9302 can control the hair-follicle eliminating activities of the auto-reactive immune cells by extending and activating Treg cells.

The Company’s Chief Executive Officer and Founder, Dr Hing C. Wong, said, “Alopecia areata, a severe condition, does not have any cure. For individuals who suffer from the risk and stress of this disease, it can adversely affect an individual's self-esteem and quality of life, which is accelerating the rate of depression and anxiety. The previous off-label treatments can offer a sort of relaxation to the symptoms, but the possibility of extreme side effects remains.”

Wong added, “The HCW9302, a novel IL-2-based blended molecule, has been described to be a tolerable one in the non-human primate studies. This is the best improvement then any conventional IL-2 therapies. We are thrilled to be the sponsor of this special and powerful clinical study to examine this valuable new treatment for alopecia areata.”

HCW’s study insights

The Phase 1 multi-center dose-escalation study of HCW9302 is engineered to treat around 30 alopecia areata patients. The initial objectives of the study are to examine the safety volume of HCW9302, the determined reference dose level, to enhance to later phase clinical studies. Another objective is the evaluation of disease responses and the impact of HCW9302 on the function of immune cells and proliferation, mainly Treg cells. 

Author

Mansi Kadam

Mansi Kadam

Mansi Kadam is a market research writer with over 3 years of experience analyzing trends in the healthcare industry. At Towards Healthcare, she covers innovations in medical sector, sustainability initiatives, and the evolving regulatory landscape.