HCW11-018b

October 9, 2026: HCW Biologics (NASDAQ: HCWB) said a recent FDA Type B meeting provided guidance for preparing an IND for HCW11-018b, supporting a first-in-human clinical study in cancer; the IND remains targeted for 1H 2027, and cGMP manufacturing for clinical trials is underway.

HCW11-018b is the lead candidate in the company’s second-generation, non-Fc-based T-Cell Engager program for solid tumors. The molecule targets tissue factor (TF)-positive tumor cells and includes an anti-CD3 single-chain antibody, a TF-targeting antibody domain, soluble IL-15, an IL-15 receptor alpha domain, and a TGF-beta receptor II trap.

The company said the program is intended to address limitations of BiTEs in solid tumors by reducing immunosuppression and promoting activation and tumor infiltration of cancer-fighting cells. The release does not report new clinical efficacy data; the catalyst is FDA regulatory feedback and continued IND-enabling progress toward a planned 1H 2027 filing.