HCW11-018b

July 23, 2026: HCW Biologics Inc. (NASDAQ: HCWB) announced it has requested a Type B pre-IND meeting with the U.S. FDA to discuss development and regulatory strategy for HCW11-018b, its investigational tetravalent T-cell engager (TCE) built on its TRBC platform. HCW11-018b is intended for subcutaneous administration to treat solid tumors that overexpress human tissue factor, including gynecologic and pancreatic cancers.

The company cited extensive preclinical work (including in vitro/in vivo potency, antigen specificity, pharmacokinetics, and nonhuman primate toxicology) suggesting HCW11-018b may address limitations of earlier-generation TCEs in solid tumors. HCW11-018b (“Big BiTE”) combines a tissue factor-targeting BiTE with IL-15 immune stimulation and a TGF-β trap aimed at reducing tumor microenvironment immunosuppression; the company stated preclinical studies showed robust antigen-specific tumor killing and that it did not trigger cytokine release syndrome within its therapeutic dose range.

HCW also said it has developed a streamlined, cost-efficient manufacturing process using high-producing CHO cell lines and a proprietary monoclonal antibody for affinity purification; the antibody is being made under GMP standards by a CDMO.