Senhwa Biosciences Enters Immunotherapy Market with New Clinical Trial

September 16, 2025
Senhwa Biosciences has announced a collaboration with Sanofi and Regeneron Pharmaceuticals to evaluate its drug Pidnarulex in combination with Cemiplimab for colorectal cancer treatment.

Senhwa Biosciences has announced its entry into the global immuno-oncology market with a new clinical trial. In a press release, the company revealed that its investigational drug Pidnarulex (CX-5461) will be tested in combination with the PD-1 inhibitor Cemiplimab (Libtayo®), provided by Regeneron Pharmaceuticals and Sanofi. This Phase 1/2 trial targets patients with microsatellite-stable colorectal cancer (MSS CRC) who are resistant to immune checkpoint inhibitors.

The trial is part of Senhwa's five-year cancer research program sponsored by the U.S. National Cancer Institute (NCI). An Investigational New Drug (IND) application has been submitted to the U.S. FDA. The collaboration aims to enhance the efficacy of immunotherapy by combining CX-5461 with PD-1 inhibitors, potentially improving response rates in solid tumors.

Senhwa's strategic partnership underscores the potential of CX-5461 to transform cancer therapy by overcoming current treatment limitations in MSS CRC and other low-immunogenicity tumors. The company continues to advance global collaborations to accelerate the development and commercialization of CX-5461.

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