HCW Biologics Inc. announced that its lead second-generation, tissue-factor-targeting T-cell engager (TCE) was well tolerated in a non-human primate safety study, with no overt toxicity or cytokine release syndrome observed even at doses significantly above the identified efficacious level, according to the company. The TCE also promoted effector T-cell activity, the company said that it was administered subcutaneously and showed safe dose levels.
The program, built on HCW’s proprietary TRBC platform, is designed to overcome limitations of first-generation TCEs—such as manufacturing complexity, safety concerns, and lack of efficacy against solid tumors—in part by targeting both cancer antigens and reducing tumor microenvironment immunosuppression, the company claims. Its two lead candidates target tissue factor and mesothelin and have shown strong antigen-specific anti-pancreatic cancer activity in vitro and in humanized mouse models.
The company said that its TRBC-based TCE manufacturing process is streamlined and cost-effective. Tissue factor is already a validated oncology target, as shown by Pfizer’s TIVDAK® for cervical cancer, and is highly expressed in aggressive solid tumors, HCW noted.
HCW believes these findings support discussions with potential high-value corporate partners and may enable expansion of its TCE pipeline to treat a broader range of indications, including solid tumors such as pancreatic cancer and glioblastoma, the company said that the results provide a basis for future development.
