HCW Biologics Inc. (NASDAQ: HCWB) has unveiled promising results for its proprietary fusion protein, HCW9206, which offers a novel approach to generating chimeric antigen receptor T cells (CAR-Ts) with significantly enhanced functionality. The findings, presented at the 2025 Annual Meeting of the American Association of Immunologists in Honolulu, demonstrate that HCW9206 outperforms conventional methods for CAR-T production.
HCW9206 represents a breakthrough in immunotherapeutic design, enabling a single molecule to deliver synergistic signals from three different immune-stimulatory cytokines. The company's studies show that this approach is markedly superior to standard methods that employ anti-CD3/anti-CD28 antibodies and IL-2 for CAR lentiviral transduction and subsequent expansion of human CAR-Ts.
Superior Performance in Preclinical Models
Research conducted in collaboration with Dr. Harris Goldstein's laboratory at the Albert Einstein College of Medicine revealed that HCW9206 not only improves CAR-T viral transduction but also effectively expands stem cell-like memory T cells (Tscm) carrying CAR constructs. This is particularly significant as Tscm cells are known to exhibit greater in vivo persistence and more effective targeted cell killing compared to other T cell subsets following adoptive transfer into patients.
In experimental humanized mouse models, the HCW9206-generated CAR-Ts demonstrated enhanced potency in suppressing both HIV-1 and leukemic cells, with significantly improved persistence compared to CAR-Ts produced using conventional methods. These findings suggest that HCW9206 could address one of the most persistent challenges in CAR-T therapy: maintaining long-term efficacy through improved cell survival.
"The results represent an alternative novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a Tscm cell phenotype," explained a company spokesperson. "This should enhance the persistence of CAR-Ts in patients and likely improve long-term survival of disease-specific CAR-Ts following adoptive transfer."
Addressing Key Challenges in CAR-T Therapy
CAR-T therapy has emerged as a revolutionary approach for treating various cancers, particularly B-cell malignancies, with several CD19-specific CAR-T therapies already approved by the FDA. However, the technology faces significant challenges, including manufacturing complexity, high costs, and variable persistence of the engineered cells in patients.
Dr. Hing C. Wong, Founder and CEO of HCW Biologics, highlighted the potential impact of their innovation: "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."
The company believes HCW9206 could also provide an entry point into the emerging field of "in-vivo CAR-T manufacturing technology," potentially further simplifying the production process.
Current Development Status and Commercial Strategy
HCW Biologics has already established the GMP master cell bank of HCW9206 and its manufacturing process, and has filed a drug master file as an ex vivo reagent with the U.S. Food and Drug Administration. This positions the company to rapidly advance toward commercial applications.
The company is currently seeking commercial partnerships for HCW9206 reagent sales and/or integration into CAR-T based manufacturing processes. This strategic approach could accelerate the adoption of HCW9206 across the growing field of cell therapy development.
Broader Implications for Immunotherapy
Beyond its immediate applications in CAR-T production, HCW9206 represents part of HCW Biologics' broader mission to develop immunotherapies targeting chronic inflammation and age-related diseases. The company's approach focuses on addressing the underlying inflammatory processes that contribute to various conditions, including cancer, autoimmune diseases, and neurodegenerative disorders.
HCW Biologics has developed multiple technology platforms, including their legacy TOBI™ (Tissue factOr-Based fusIon) platform and the newer TRBC platform, which has generated over 50 novel immunotherapeutic molecules to date.
The positive results for HCW9206 suggest that the company's innovative approach to immunotherapy design could have far-reaching implications for treating a wide range of diseases, potentially improving patient outcomes while reducing healthcare costs associated with complex cellular therapies.
Future Directions
While the current studies demonstrate promising results in preclinical models, the translation of these findings to human clinical applications will be the critical next step. The ability of HCW9206 to activate Tscm cells in patients and improve long-term survival of disease-specific CAR-Ts will need to be confirmed in clinical trials.
Nevertheless, the data presented at AAI 2025 provide a strong foundation for further development and suggest that HCW9206 could represent a significant advancement in the field of cellular immunotherapy, potentially expanding the reach and effectiveness of CAR-T therapies across multiple disease indications.
