HCW Biologics Inc. (the “Company” or “HCW Biologics”), a U.S.-based clinical-stage biopharmaceutical company focused on developing novel fusion immunotherapeutics to treat autoimmune diseases, cancer, and senescence-associated dysplasia, announced receipt of a Notice of Allowance from the U.S. Patent and Trademark Office (“USPTO”) for claims directed to use of HCW9302 to treat alopecia areata (U.S. Patent Application Publication No. US2026/0139043).

Together with four other recently issued patents (U.S. Patent No. 11,401,326, U.S. Patent No. 11,987,619, U.S. Patent No.12,018,071, U.S. Patent No. 12,516,112) with claims for broad compositions, nucleic acids encoding for HCW9302 and the vectors comprising these, and method of treating other autoimmune diseases, the underlying U.S. patent estate has been further strengthened for the protection of the Company’s intellectual property related to further development and potential commercialization of HCW9302, a best-in-class IL-2-based immunotherapeutic for the treatment of autoimmune diseases. The Company continues to extend protection of its broad rights for treatments for all indications with respect to HCW9302 built on the foundation of its worldwide, perpetual, fully paid-up, royalty-free, exclusive license rights for this compound.    

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “Our lead clinical product candidate HCW9302 exhibits a strong IL-2Rα bias, a unique and novel mechanism of action, while preferentially expanding and stimulating T_reg cells to reduce pro-inflammatory and autoimmune responses in relevant animal models, including alopecia areata, atherosclerosis, and atopic dermatitis. This strong IL-2Rα bias differentiates HCW9302 from native recombinant IL-2 and other IL-2-based muteins and PEG conjugates, which typically exhibit reduced binding activity to IL-2Rα components. In addition, HCW9302 is comprised of all human-derived components and can be produced with a cost-effective, streamlined process similar to therapeutic monoclonal antibodies. Ongoing clinical activity for alopecia areata patients continues to be encouraging. With exceptionally strong intellectual property protection in place, we are vigorously pursuing alopecia areata as our lead indication of HCW9302