Our Programs
With our platform technologies, we have generated product candidates that are designed to direct the immune system against autoimmune diseases, cancer and senescence-associated dysplasia.
Commercial-Ready Programs
HCW9206: Multi-Cytokine Protein Fusion for Production of CAR-T Therapies that Improves Treatment of Cancer and Infectious Diseases
Ribbon Diagram of HCW9206
HCW9206 is a novel immunotherapeutic engineered to deliver synergistic signaling from three immune-stimulatory cytokines within a single molecule, that provides a revolutionary approach to generate Chimeric Antigen 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). This strategy is broadly applicable to increase persistence and functionality of CAR-Ts, potentially enhancing their efficacy for treating infectious diseases and cancer. Treating T cells with HCW9206 can quickly and effectively produce HIV- and CD19-specific CAR-T cells that are highly enriched for the Tscm memory phenotype, as well as effector T cells capable of maintaining suppression of HIV and leukemic cell proliferation. Therefore, generating CAR-T cells through HCW9206 treatment could provide a new, improved, and highly scalable method for generating 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 to improve CAR-T cell functional persistence and efficacy for treatment of HIV and cancer. (See: 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, Vol. 12, No.11, 13 Mar 2026).
HCW9206: Activation and Expansion of T and Natural Killer Cells for Cell-Based Therapies for Cancer and Infectious Diseases.
Beyond CAR-T applications, HCW9206 has also been utilized to expand Cytokine-Induced Memory-Like (CIML) NK cells using a feeder cell-free “Prime and Expand” strategy. In this approach, HCW9206 is combined with an IgG1 antibody that recognizes the scaffold domain of HCW9206, enabling CD16-mediated NK cell engagement during the expansion phase. This cytokine- and CD16-dependent process generates CIML NK cells with enhanced metabolic fitness, stable epigenetic IFNG promoter demethylation, improved anti-tumor activity in vitro and in vivo, and superior persistence in NSG mouse models. The platform represents a streamlined, feeder cell–free manufacturing strategy designed to support multi-dose infusion and off-the-shelf adoptive cell therapy (ACT).
Collectively, these findings position HCW9206 as a next-generation CAR-T and NK cell manufacturing reagent capable of streamlining production, reducing reliance on multi-component activation systems, and potentially lowering manufacturing costs. By improving CAR-T functionality and durability, the long-standing challenges in the field, HCW9206 may enhance long-term therapeutic outcomes in malignancies, chronic infections, and autoimmune diseases, while also supporting emerging in vivo CAR-T manufacturing technologies.
The GMP master cell bank and manufacturing process for HCW9206 have been established, and a Drug Master File for its use as an ex vivo reagent has been filed with the U.S. Food and Drug Administration. HCW9206 is currently positioned as a commercial-ready product for CAR-T–based manufacturing applications.
HCW Biologics holds the perpetual, exclusive worldwide license to develop immunotherapeutic treatments based on HCW9206 for all disease indications, with some commercially-reasonable restrictions for cancer indications.
HCW9201: Generation of CIML NK Cells
NK cells are a promising cellular therapy for cancer, with challenges in the field including persistence, functional activity, and tumor recognition. Brief priming of blood NK cells with HCW9201, a fusion molecule comprising IL-12, IL-15, and IL-18, results in differentiation of highly active memory-like NK cells, which have enhanced responses against cancer. Based on one of our published articles, HCW9201 stimulation improved NK cell metabolic fitness, and resulted in the DNA methylation remodeling characteristic of memory-like differentiation. Additionally, HCW9201 treatment increases memory-like NK cell cytotoxicity and Interferon-Gamma production against leukemia targets. HCW9201-primed NK cells also controlled leukemia in vivo in humanized mouse models. HCW9201 represents a protein engineering approach that solves many problems associated with multi-signal receptor engagement on immune cells, and HCW9201-primed NK cells will be advanced as an ideal approach for clinical GMP-grade memory-like NK cell production for cancer therapy. In addition, the molecule has been demonstrated to be compatible with NK cell manufacturing platforms, further supporting its versatility in immune cell therapy production.
The GMP master cell bank and manufacturing process for HCW9201 have been established, and a Drug Master File for its use as an ex vivo reagent has been filed with the U.S. Food and Drug Administration. HCW9201 is currently positioned as a commercial-ready product for Cytokine Induced Memory Like (CIML) NK cell–based manufacturing applications.
Clinical-Stage Product Candidate
HCW9302: Treg Expansion and Activation
Ribbon diagram of HCW9302
HCW9302 is an injectable, first-in-kind interleukin 2 (“IL-2”) fusion protein constructed using the Company’s proprietary TOBI platform technology. Its mechanism of action involves binding to IL- 2αβγ receptors predominantly expressed on regulatory T (“Treg”) cells, thereby activating and expanding Treg cells, but not effector T cells. The HCW9302-activated Tregs can then suppress unwanted immune and inflammatory responses.
We are currently evaluating HCW9302 in a clinical study to verify our preclinical studies that found HCW9302 functions as a potent agent to stimulate and expand Treg cells that suppress the activity of proinflammatory cells and factors. We have observed a long serum half-life compared with recombinant interleukin-2 (rhIL-2), a US FDA licensed drug for renal cell carcinoma and metastatic melanoma, which contributed to the ability of subcutaneously administered HCW9302 to activate and expand Treg cells in mice in a well-tolerated dose range without activating proatherogenic CD4+ T cells. CD4+ effector T cells (also known as helper T cells) are crucial for immune responses, but under certain conditions, their excessive activation can lead to negative effects. This finding also suggests that greater CD25-mediated Treg activation may be superior to “mutein”-based strategies to prevent or diminish IL-2 binding to IL-2Rβγ on effector cells.
For further details, see our publication entitled “A NovelInterleukin-2-Based Fusion Molecule, HCW9302, Differentially Promotes Regulatory T Cell Expansion to Treat Atherosclerosis in Mice,” Frontiers in Immunology 2023 Jan 25;14:1114802.
HCW9302: Autoimmune Disorders and Other Therapeutic Applications
A Company-sponsored, multi-center first-in-human clinical trial is currently being conducted to evaluate HCW9302 in patients with alopecia areata (NCT07049328). We have two clinical sites actively enrolling patients at The Ohio State University Wexner Medical Center and James A. Haley Veterans’ Hospital, and we are adding additional clinical sites to further facilitate this promising trial. Once the recommended Phase 2 dose level and safety profile of HCW9302 are established in a successful Phase 1 study, we expect to expand to other carefully selected indications in Phase 2 clinical studies.
Treg cells play a critical role in controlling inflammation in conditions such as atopic dermatitis and in maintaining immune tolerance in transplant patients, making HCW9302 a promising therapeutic strategy beyond alopecia areata. Following the Phase 1 dose escalation study in alopecia areata, HCW9302 is expected to expand into other therapeutic areas, including atopic dermatitis and organ transplantation, which represent major unmet medical needs.
IND-Enabling-Stage Product Candidates
HCW11-006: Activation and Expansion of Immune Cells
HCW11-006 is a fusion molecule which combines several different immune functional domains as part of a group of compounds characterized as multi-functional immune cell stimulators. This lead product candidate will be developed in partnership with Beijing Trimmune Biotech Co., Ltd. (“Trimmune”), the licensee responsible for the development and commercialization of HCW11-006 in vivo. Licensee expects to initiate Phase 1 clinical study in Q2 2027 for an undisclosed indication comprising a large patient population. We have a free-opt-in right which may be exercised upon completion of the Phase 1 trial in China. Opt-in territory is for the American Markets.
HCW11-040: Second-Generation Immune Checkpoint Inhibitor (“ICI”)
HCW11-040 is a multifunctional fusion molecule that is a unique combination of cytokines and pembrolizumab, a generic form of Keytruda®. It shows ability to expand Progenitor exhausted T (“Tpex”) cells, which are the primary cells to respond to ICI therapy, without triggering cytokine storm in preclinical studies. HCW11-040 exhibits superior immune-cell activation, expansion, and cytotoxicity against cancer cells and tumors over Keytruda® in in-vitro and in-vivo studies. Its target indications include senescence-associated disease, i.e. Bronchopulmonary Dysplasia (BPD) and solid tumors. IND-enabling studies are expected to be completed in Q3 2027.
HCW11-018b: Lead Tetravalent “BIG-BiTE” Program
HCW11-018b is a novel, tetra-valent T-Cell engager (“TCE”) we call the Big BiTE, since it consists of a BiTE (common for all T-Cell Engagers) and an Enhancer (which makes the HCWB T-Cell Engager the “BIG BiTE”). It is designed to address key challenges for first generation T-Cell Engagers: manufacturability, preclinical safety profile, and ability to treat solid tumors. In our extensive preclinical studies, it induces robust, sustained, antigen-specific tumor killing, enhances CD8⁺ T-cell activation, survival, and effector functions and promotes tumor infiltration into solid tumors. It combines a tumor-associated tissue factor-targeting BiTE with IL-15 immune stimulation and a TGFβ trap to overcome immunosuppression and poor T-cell infiltration of conventional BiTEs in solid tumors. In non-human primate studies, HCW11-018b has demonstrated favorable tolerability, a long serum half-life and favorable pharmacokinetics, without using the Fc fusion technology commonly found in bi-specific or tri-specific fusion molecules. Extensive preclinical studies further show that HCW11-018b does not trigger cytokine release syndrome, a major concern of using BiTEs, when used in its therapeutic dose range. IND-enabling studies are expected to be completed in Q1 2027.
