MIRAMAR, Fla., Sept. 2, 2026

HCW Biologics Inc. (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing fusion immunotherapeutics for autoimmune diseases, cancer and other chronic inflammation-driven conditions, announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for claims covering the use of its lead clinical-stage candidate HCW9302 as a treatment for alopecia areata. The allowance, associated with U.S. Patent Application Publication No. US2026/0139043, further strengthens the company’s intellectual property position around HCW9302 as it advances the candidate through clinical development. HCW Biologics is pursuing alopecia areata as the lead indication for HCW9302 and expects to complete its ongoing Phase 1 dose-escalation study in the fourth quarter of 2026.

HCW9302 Intellectual Property Estate Expands Across Key Claims

The newly allowed patent claims add to a broader U.S. patent estate supporting HCW9302. HCW Biologics highlighted four recently issued U.S. patents covering areas including HCW9302 compositions, nucleic acids encoding HCW9302, vectors containing those nucleic acids, and methods of treating autoimmune diseases. The company said the expanded patent protection is intended to support the further development and potential commercialization of HCW9302 across multiple indications. HCW9302 is an IL-2-based immunotherapeutic designed to preferentially expand and activate regulatory T cells (Tregs), with the objective of reducing pro-inflammatory and autoimmune responses. HCW Biologics also stated that it holds worldwide, perpetual, fully paid-up, royalty-free, exclusive license rights for HCW9302, providing a foundation for its continued development and intellectual-property strategy.

HCW Biologics Continues Phase 1 Development in Alopecia Areata

Alongside the patent milestone, HCW Biologics reported continued progress in its ongoing Phase 1 clinical study evaluating HCW9302 as a monotherapy in patients with alopecia areata. The dose-escalating study is currently on track for completion in Q4 2026, according to the company. HCW Biologics said HCW9302 continues to be well tolerated in the clinical study, with no dose-limiting toxicities reported to date. The company also reported that preliminary observations from the first two dose cohorts were encouraging, including positive responses following a single dose at the 3 micrograms/kg dose level. These observations remain preliminary, and the company plans to provide the full Phase 1 readout in Q4 2026, making the upcoming clinical update an important development milestone for HCW9302.

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HCW9302 Targets Autoimmune Disease Through Treg Activation

HCW Biologics is developing HCW9302 around a differentiated IL-2Rα-biased mechanism intended to preferentially stimulate and expand Treg cells. According to the company, this approach is designed to distinguish HCW9302 from native recombinant IL-2 and other IL-2-based approaches. HCW9302 consists of human-derived components and is designed to be manufactured through a streamlined process similar to therapeutic monoclonal antibodies. Beyond alopecia areata, HCW Biologics has investigated the candidate in preclinical models involving other inflammatory and autoimmune conditions, including atherosclerosis and atopic dermatitis. With its strengthened U.S. patent estate and the ongoing Phase 1 program, the company is positioning HCW9302 for further development while preparing for the anticipated Q4 2026 Phase 1 clinical readout.

Source:HCW Biologics, press relese