HCW Biologics Inc. announced the designation of HCW11-040, a TRBC-based second-generation, pembrolizumab-based immune checkpoint inhibitor, as its lead product candidate for internal clinical development. This decision is based on definitive preclinical data shared at a scientific seminar series on September 12, 2025.
HCW11-040 is a multi-functional fusion protein combining pembrolizumab with interleukin (IL)-7, IL-15, and TGF-β receptor components. Preclinical studies demonstrated that this unique combination can expand Progenitor Exhausted T (TPEX) cells and stimulate their differentiation into anti-cancer effector T cells, independent of ICI therapy.
The preclinical data showed HCW11-040 outperformed pembrolizumab monotherapy in immune-cell activation, expansion, infiltration into tumors, and cytotoxicity against cancer cells. Furthermore, preclinical models indicated that HCW11-040 is not likely to overstimulate the immune system, avoiding cytokine storm, when administered subcutaneously at projected efficacious dose levels. The company will now advance HCW11-040 into late phase IND-enabling studies.
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