On October 9, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on developing novel fusion immunotherapeutics to treat autoimmune diseases, cancer, and senescence-associated dysplasia, reported to maintain momentum toward filing an IND application to evaluate HCW11-018b, the lead product candidate in its second-generation, non-Fc-based T-Cell Engager Program, in the treatment of solid tumors. The Company’s T-Cell Engager Program is derived from its proprietary drug discovery and development TRBC platform, which features a protein-based scaffold that allows for the construction of tetravalent molecules.
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T-Cell Engagers, particularly bispecific T-Cell Engagers ("BiTEs"), are promising cancer immunotherapies for hematologic malignancies. However, their success against solid tumors has been limited because the immunosuppressive tumor microenvironments and physical barriers can reduce their effectiveness and impede infiltration by cancer-fighting immune cells.
HCW11-018b incorporates the core features of a BiTE while adding components that alleviate immunosuppression and promote activation and tumor infiltration of cancer-fighting cells. The BiTE component of HCW11-018b contains an anti-CD3 single-chain antibody and an antibody domain that targets human Tissue Factor ("TF"), which is overexpressed in a wide spectrum of solid tumors. In addition, the molecule includes soluble IL-15, an IL-15 receptor α ("IL-15Rα") domain, and a TGF-β receptor II ("TGFβRII") domain trap. The result is a compound that targets TF-positive tumor cells, engages CD3 on T cells, incorporates IL-15/IL-15Rα activity, and uses a soluble TGFβRII domain as a TGF-β trap to reduce immunosuppression.
Targeting TGF-β has emerged as a promising strategy in cancer therapy. Besides its direct effects on cancer cells, TGF-β pro-tumorigenic activity includes its immunosuppression effects on CD8+ and NK cells, induction of regulatory T cells, and hindrance of effector-cell infiltration into the tumors by modulating monocytes and macrophages in the tumor microenvironment. The Company included IL-15 because it is an attractive immune-stimulatory cytokine that supports CD8+ T-cell and NK cell survival, proliferation, and cytotoxic functions without inducing the activation cell death phenomenon mediated by IL-2.
Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, "Tissue factor has been shown to be highly expressed by various solid tumors. Cancers that hijack the body’s TF are very difficult-to-treat cancers. They use TF to avoid immune-cells that would attack them, use extracellular matrix interactions to promote the growth of cancer, increase chances for metastasis, and build resistance to standard-of-care therapies."
Dr. Wong continued, "With our non-Fc based T-Cell Engager program derived from the TRBC platform technology, we have created a second-generation T-Cell Engager, HCW11-018b. HCW11-018b has demonstrated that the addition of TGFβ-trap and IL-15 components onto a BiTE domain can overcome the deficiencies of BiTE alone for solid tumor therapy. We are pleased with the clear regulatory guidance provided by the FDA at our recent Type B meeting regarding the preparation of an IND application for a first-in-human clinical study of HCW11-018b in cancer. This guidance enables us to maintain our momentum toward achieving our target to file the IND application in the 1H 2027."
(Press release, HCW Biologics, OCT 9, 2026, View Source [SID1234673306])