HCW Biologics Reports Positive Preliminary Phase 1 Data for IL-2 Fusion Immunotherapeutic HCW9302 in Alopecia Areata
核心洞察
HCW Biologics announced a positive preliminary human data readout from the first two dose cohorts of its Phase 1 trial of HCW9302, an IL-2-based fusion immunotherapeutic, in patients with alopecia areata (搜索).
All three participants in the second dose cohort (3 micrograms/kg) showed a ≥25% reduction in SALT scores at four and/or nine weeks after a single subcutaneous dose.
HCW9302 was well tolerated, with no dose-limiting toxicities, capillary leak, cytokine release syndrome, or increased blood eosinophil counts.
HCW Biologics Inc. (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company, announced a positive preliminary human data readout for the first two dose cohorts of its dose-escalating Phase 1 clinical trial evaluating HCW9302, an IL-2-based fusion immunotherapeutic, as a monotherapy in patients with alopecia areata (搜索). The announcement, made on June 16, 2026, highlights early signals of clinical benefit alongside a well-tolerated safety profile following a single subcutaneous dose.
In the second dose cohort, comprised of patients who received a single subcutaneous dose of HCW9302 monotherapy of three (3) micrograms/kg body weight, all three participants showed preliminary indications of improvement in Severity of Alopecia Tool (SALT) scores. These three participants, all with mild alopecia, showed a ≥25% reduction in SALT scores compared to baseline at four and/or nine weeks after dosing. Treatment of patients in the third dose cohort (eight (8) micrograms/kg body weight) is underway, and evaluation of correlative study endpoints is ongoing.
Safety Profile and Tolerability
All patients, including the first dose cohort at one (1) microgram/kg body weight and the second dose cohort at three (3) micrograms/kg body weight, received a single subcutaneous dose of HCW9302 monotherapy. There were no reported incidences of capillary leak or cytokine release syndromes associated with high-dose intravenous IL-2 therapy. Additionally, HCW9302 treatment did not increase blood eosinophil counts, another serious side effect commonly associated with IL-2 therapy. All reported HCW9302 treatment-emergent adverse events were mild in severity and self-limiting, resolving without medical intervention. The most common side effect was temporary injection-site reaction. The Company has not reported any dose-limiting toxicities.
Mechanism of Action
These preliminary findings support the Company's belief that HCW9302 has the potential to activate and expand regulatory T (Treg) 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 (搜索), the Company believes that HCW9302 can suppress the hair-follicle killing activities of the auto-reactive immune cells by activating and expanding Treg cells.
Dr. Hing C. Wong, the Company's Founder and Chief Executive Officer, commented, "The positive preliminary human data readout from the first two cohorts of the Phase 1 clinical study of HCW9302 monotherapy for alopecia areata (搜索) is highly encouraging, showing potential benefit along with a well-tolerated safety profile even with a single, subcutaneous low-dose regimen. The results are consistent with our pre-clinical studies which demonstrated that HCW9302 exhibits a strong IL-2 receptor α (搜索) bias, a unique and novel mechanism of action, while preferentially expanding and stimulating Treg cells to reduce pro-inflammatory and autoimmune responses in animal disease models, including alopecia and atherosclerosis."
Dr. Wong further noted that HCW9302 targets CD25 (搜索) directly, which the Company believes demonstrates activation and expansion of regulatory T cells. He added, "Our design does not use pegylation, so we avoid anti-PEG immune responses, which account for efficacy loss and can possibly cause severe allergic symptoms."
Clinical Trial Design
The Phase 1 multi-center dose-escalation study (Clinicaltrials.gov: NCT07049328) of HCW9302 monotherapy is designed to treat up to 30 patients with alopecia areata (搜索). The primary objectives of the study are to evaluate the safety of HCW9302, injected as a single dose 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 Treg cells.
There are two active clinical sites enrolling patients: The Ohio State University Wexner Medical Center in Columbus, Ohio, and the James A. Haley Veterans' Hospital in Tampa, Florida.
Development Timeline and Future Indications
The Company remains on track for a full Phase 1 clinical data readout in the fourth quarter of 2026 and projects establishing the recommended Phase 2 dose by year-end 2026. Dr. Wong stated, "We are progressing through dose escalation in this clinical study with the objective to establish the safe recommended Phase 2 dose by year-end. Patient enrollment remains on track, and we have initiated dosing patients in the third dose escalation cohort."
Regarding potential indications for Phase 2 studies, Dr. Wong added, "Once we achieve our objective to establish the recommended Phase 2 dose, we will consider expanding clinical studies to evaluate multi-dose HCW9302 monotherapy in Phase 2 studies in patients with alopecia areata (搜索), as well as other autoimmune diseases and inflammatory dermatological conditions, such as vitiligo and atopic dermatitis." He also noted that recently published clinical evidence suggests patients with Amyotrophic Lateral Sclerosis (ALS), an autoimmune neuroinflammatory disease, may respond positively to combined Treg cell and IL-2 treatment, positioning HCW9302 as a potential opportunity for neurodegenerative diseases such as ALS.
About HCW9302
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 IL-2-based fusion immunotherapeutic molecule constructed with a proprietary tissue factor scaffold. IL-2, the active component of HCW9302, is the cytokine responsible for maintaining the proper numbers and functions of Treg cells in the body, which control excessive inflammation caused by other immune cells—the etiology of autoimmune diseases.
In pre-clinical studies, HCW9302 was found to bind with high affinity to the IL-2 receptor α (搜索) chain (IL-2Rα) expressed on the surface of Treg cells, resulting in preferential stimulation of Treg proliferation and activation compared to CD4+ and CD8+ T cells and Natural Killer cells. This strong IL-2Rα bias highly differentiates HCW9302 from native recombinant IL-2 and other IL-2-based muteins and PEG conjugates, which typically exhibit reduced binding activity to IL-2 receptor components. HCW9302 is comprised of all human-derived components and can be produced with a cost-effective, streamlined process similar to therapeutic monoclonal antibodies.
Disease Background
Alopecia areata (搜索) (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, 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.
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 (搜索).