On March 16, 2026 HCW Biologics Inc. ("HCWB" or the "Company") (NASDAQ: HCWB), is a U.S.-based commercial- and clinical-stage biopharmaceutical company focused on supporting or developing novel immunotherapies to treat autoimmune diseases, cancer, and senescence-associated dysplasia, reported results of groundbreaking research studies, published in the peer-reviewed, high-impact journal, Science Advances (Cole et al., "IL-7/IL-15/IL-21 cytokine-fusion scaffold generates highly functional CAR-T cells enriched in long-lived T memory stem cells" Science Advances, 13 Mar 2026, Vol 12, Issue 11). These studies were led by Harris Goldstein, M.D., professor of pediatrics and of microbiology & immunology and director of the Einstein-Rockefeller-CUNY-Mount Sinai Center for AIDS Research and his team of Albert Einstein College of Medicine scientists, most notably Erin Cole, M.S., a graduate student in the Goldstein laboratory.
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The study results demonstrated that HCW9206, the Company’s proprietary and commercial-stage multi-cytokine fusion protein reagent, provides a revolutionary approach to generate chimeric T-cell receptor – T cells ("CAR-Ts") for immunotherapy with increased function in a cost-effective manner. HCW9206, a first-in-class cytokine-scaffold-based platform, enables production of more potent CAR-T-based immunotherapies by generating a CAR-T population which is highly functional and markedly enriched for long-live T-memory stem cells (Tscm). Utilizing HCW9206 as a manufacturing strategy may be broadly applicable to increase persistence and functionality of CAR-Ts.
Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, "HCW9206 is a novel compound that enables a single molecule to deliver synergistic signals from three different immune-stimulatory cytokines. It is versatile and has shown activity in the creation of memory-like NK-cells for cell-based therapy against cancer, and now we also discovered it has the potential to enhance the production of CAR-T therapies as a promising novel reagent to replace the current industry-standard method that relies on anti-CD3/anti-CD28/IL-2-based approaches. An approach that employs HCW9206 as a reagent is more streamlined and may lower the cost of CAR-T manufacturing. Equally important, based on experimental models, HCW9206 has shown improvement in functional activities and persistence of CAR-Ts following adoptive transfer, a goal the industry has been trying to achieve for the last decade."
Functional persistence of CAR-Ts is limited by conventional and costly manufacturing methods utilizing anti-CD3/CD28 (αCD3/28)/IL-2 stimulation, which generates terminally differentiated and shorter-lived CAR-Ts. Utilizing HCW9206 during the manufacture of CAR-Ts synergizes the effects of IL-7, IL-15 and IL-21 to promote the generation of a CAR-T cell product with a diverse mix of T cell subsets that exhibit a combination of Tscm self-renewal capacity and enhanced T cell effector function, likely from the TEM population. In this pivotal publication, the authors show how HCW9206, when used in the manufacture of CAR-T, stimulates proliferation of CD8+T cells, particularly those within the Tscm subset. As a result, HCW9206 was shown to generate CAR-Ts without requiring αCD3/28/IL-2 activation which are highly enriched in long-lived Tscm (50% or more) and display potent activity across distinct disease experimental models, namely, HIV-1 or B-cell leukemia. In preclinical studies, CAR-Ts manufactured using HCW9206 were significantly superior compared to CART-Ts manufactured using standard methods employing anti-CD3/anti-CD28 and IL-2 reagents for CAR lentiviral transduction and subsequent expansion and persistence of highly active human CAR-Ts. While there is still a need to confirm in clinical studies, this research suggests that CAR-T cells produced with HCW9206 may be a more effective and long-lasting CAR-T cell immunotherapy than conventional CAR-T produced using αCD3/28/IL-2.
In this article, the authors demonstrate in a humanized mouse model of HIV-1 infection utilizing T cells from people living with HIV (PLWH), HCW9206 enabled generation of duoCAR-T cells composed of a highly enriched Tscm population, which supported long-term persistence and functional activity in vivo, along with the effector memory T cells (TEM) population capable of providing immediate and potent HIV-1 suppression. Utilizing HCW9206 in the manufacture of CAR-Ts may advance HIV immunotherapy by introducing a new strategy that may produce functionally persistent product, thereby extending the lifespan of anti-HIV CAR-T therapy in PLWH and potentially enabling a functional cure. The authors also show how anti-cancer CD19-CAR-T cells manufactured using HCW9206 exhibited a greater capacity to mount a protective proliferative response in vivo, as indicated by the effective suppression of tumor cell expansion after rechallenging with CD19+ cancer cells by HCW9206-generated CD19-CAR-T cells compared to the (αCD3/28)-generated CD19-CAR-Tcells in multiple humanized animal models.
The authors of this article also reported that antigen stimulation of duoCAR-T produced with HCW9206 significantly upregulated the expression of SATBI1 (special AT-rich sequence-binding protein 1), a gene previously reported to be a key determinant in linage commitment through chromatin reorganization. Specifically, SATB1 has been shown to be a key regulator of CD8+ T-cell quiescence and stemness, as well as promoting early effector cell expansion and differentiation to support both effector responses and long-term T-cell persistence.
Taken together, these data demonstrate that manufacturing human T cells with HCW9206 produces HIV- and CD19-specific CAR-T cells that are highly enriched for the Tscm memory phenotype, as well as human effector T cells capable of maintaining suppression of HIV and leukemic cell proliferation in experimental models. Therefore, generating human CAR-T cells utilizing HCW9206 could provide a new, improved, and highly scalable method for generating human CAR-T cells to treat patients with infectious disease and cancer and replace standard CAR-T cell production using αCD3/28 activation. This has widespread implications for the generation of more robust CAR-T cell-based immunotherapies with the potential to improve CAR-T cell functional persistence and efficacy for treatment of HIV and cancer.
The authors are Natalia Valderrama Pena, B.S., Niraj Shrestha, Ph.D., and Hing Wong, Ph.D. at HCW Biologics; along with Sara Lamcaj, Ph.D., Agnes Sydenstricker, B.S., Adilyn Voss, B.S., Christopher Hiner, Ph.D., and Jian Hua Zheng, B.S., Harris Goldstein, M.D. at Albert Einstein College of Medicine; Ying Xiong, Ph.D., Zhongyu Zhu, Ph.D., and Boro Dropulić, Ph.D., at Caring Cross; and Cheng Cheng Zhang, Ph.D. at University of Texas Southwestern Medical Center, Dallas, TX.
(Press release, HCW Biologics, MAR 16, 2026, View Source [SID1234663589])