Senhwa Biosciences, Inc. has reached a major milestone its recent clinical collaboration with BeOne Medicines to explore combination therapy with its marketed PD-1 inhibitor in the field of cold tumor treatment.

The company’s investigational drug Pidnarulex (CX-5461) will be evaluated in combination with the antibody-drug conjugate (ADC), Trastuzumab Deruxtecan (Enhertu), in a Phase 1b clinical trial. 

The study is designed for HER2-positive solid tumors and breast cancer patients, including those with HER2-low expression and metastatic breast cancer. Supported by the U.S. National Cancer Institute’s (NCI) NExT program, which funds multiple CX-5461 studies including combination strategies, Senhwa is working in one of the most promising areas in oncology therapeutics, and this milestone marks CX-5461’s entry into the fast-growing ADC market.

G4 Stabilizer Meets Leading ADC

CX-5461 is the first G-quadruplex (G4) stabilizer in development. It has shown promising activity in early-phase trials for breast cancer and other solid tumors in study sponsored by SU2C-CCTG in Canada. Its combination with Enhertu is expected to enhance treatment efficacy in HER2-low patients and offer new therapeutic possibilities.

Enhertu, co-developed by AstraZeneca and Daiichi Sankyo, is the first HER2-directed ADC approved for HER2-low and HER2-ultralow metastatic breast cancer. This drug uses a monoclonal antibody to precisely target tumor cells and deliver the chemotherapy payload Deruxtecan directly into the tumor, enabling highly effective cancer cell killing while minimizing harm to healthy cells.