Synergy between G4 Stabilizer and leading ADC technology Senhwa Biosciences has reached a clinical milestone by initiating a Phase 1b trial to evaluate its investigational drug Pidnarulex (CX-5461) in combination with the prominent antibody-drug conjugate (ADC) Enhertu (Trastuzumab Deruxtecan). This strategic move marks Senhwa’s entry into the rapidly expanding ADC market, specifically targeting HER2-positive and HER2-low expressing solid tumors and metastatic breast cancer.
Supported by the U.S. National Cancer Institute’s (NCI) NExT program, the study aims to validate CX-5461’s potential as a powerful partner in combination strategies for advanced oncology therapeutics.
A dual-action mechanism for enhanced efficacy CX-5461 is a first-in-class G-quadruplex (G4) stabilizer. Enhertu, co-developed by AstraZeneca and Daiichi Sankyo, is renowned for its precision in delivering chemotherapy payloads directly into tumor cells via monoclonal antibodies.
The combination of these two agents is expected to:
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Amplify cell-killing effects: By stabilizing G4 structures, CX-5461 disrupts cancer cell DNA repair, potentially increasing the sensitivity of tumor cells to the Deruxtecan payload delivered by Enhertu.
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Address unmet medical needs: The trial focuses on patients with HER2-low and HER2-ultralow expression, offering new hope for those who previously had limited targeted therapy options.
Expanding into “Cold Tumor” treatment Beyond the Enhertu collaboration, Senhwa is also working with BeOne Medicines to explore combination therapies with PD-1 inhibitors for “cold tumors”—cancers that typically do not respond to immunotherapy alone. These initiatives highlight Senhwa’s commitment to leveraging innovative biological mechanisms to redefine cancer treatment standards worldwide.
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