HCW Biologics Reports Positive Study Results For HCW9206 And Opens Door To Commercial Sales

HCW Biologics Inc., a U.S.-based clinical-stage biopharmaceutical company focused on developing innovative immunotherapies that target the link between chronic inflammation and disease to improve healthspan, has presented new research findings on its proprietary fusion protein, HCW9206. The data was shared at the 2025 Annual Meeting of the American Association of Immunologists (AAI) in Honolulu, Hawaii, through a poster presentation by Dr. Harris Goldstein’s laboratory at the Albert Einstein College of Medicine in New York.

The studies demonstrate that HCW9206 offers a new and effective method for generating chimeric antigen receptor T cells (CAR-Ts), a form of immunotherapy that has shown success in treating various cancers, particularly B-cell malignancies. Unlike conventional methods that use anti-CD3, anti-CD28, and IL-2 to activate and expand CAR-Ts, HCW9206 delivers synergistic immune-stimulatory signals from three different cytokines through a single molecule. This novel approach was found to be significantly more effective in facilitating CAR-T lentiviral transduction and improving the expansion and persistence of the resulting CAR-T cells.

One of the key findings from the study was that HCW9206 supports the expansion of stem cell-like memory T cells (Tscm) carrying the CAR construct. These Tscm cells are known for their enhanced longevity and ability to persist in the body, which can lead to more sustained therapeutic effects following adoptive transfer in patients. In experimental humanized mouse models, CAR-Ts generated with HCW9206 targeting HIV and CD19 antigens demonstrated superior suppression of HIV-1 and leukemic cells, respectively, compared to CAR-Ts produced with traditional methods.

Dr. Hing C. Wong, the Founder and CEO of the Company, said in a statement, “HCW9206 is a promising revolutionary reagent to replace anti-CD3/anti-CD28/IL-2-based approaches to streamline and lower the costs of CAR-T manufacturing. Equally important, HCW9206 can improve the functional activities and persistence of CAR-Ts following adoptive transfer, a goal that has not been achieved for the last decade. Also, it provides us with an in-road opportunity to participate in the development of the highly promising, emergent in-vivo CAR-T manufacturing technology”.

The results suggest that using HCW9206 in the CAR-T production process not only enhances the functional quality of the cells but also increases the likelihood of long-term disease control by generating a larger population of CAR-Ts with the desirable Tscm phenotype. This approach has the potential to improve the durability and effectiveness of CAR-T therapies across a range of diseases, including cancer, chronic infections, and autoimmune conditions.

HCW Biologics has completed the establishment of a GMP master cell bank for HCW9206 and has filed a drug master file with the U.S. Food and Drug Administration for its use as an ex vivo reagent. The company is currently seeking commercial partnerships for the sale of the HCW9206 reagent and its potential integration into CAR-T cell manufacturing processes.