Senhwa Biosciences is set to evaluate its investigational drug Pidnarulex (CX-5461) in combination with the antibody-drug conjugate, Trastuzumab Deruxtecan (Enhertu), in a Phase Ib clinical study.
The trial will focus on patients with human epidermal growth factor receptor 2 (HER)-positive solid tumours and breast cancer, including those with metastatic breast cancer and HER2-low expression, and is supported by the US National Cancer Institute’s NExT programme.
CX-5461 is said to be the first G-quadruplex (G4) stabiliser in development. Early-phase trials in Canada, sponsored by SU2C-CCTG, have shown promising activity in breast cancer and other solid tumours. The combination with Enhertu aims to improve treatment outcomes for HER2-low patients and expand therapeutic options.
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Enhertu, co-developed by Daiichi Sankyo and AstraZeneca, is the first HER2-directed ADC approved for HER2-low and HER2-ultralow metastatic breast cancer.
It uses a monoclonal antibody to deliver the chemotherapy payload Deruxtecan directly to tumour cells, which helps limit damage to healthy tissue.
Current HER2-targeted therapies have improved outcomes for breast and gastric cancers but have limited effectiveness in HER2-low solid tumours.
Experts state that if CX-5461’s mechanism of action combined with ADC delivery proves effective, it could address current therapy gaps and broaden indications to other tumour types.
HER2 is recognised as a significant oncogenic driver in several types of cancer.
Senhwa Biosciences plans to utilise the combination of CX-5461 and Enhertu to develop new treatment options, expand its presence in the growing ADC market, and broaden its oncology portfolio.
In November 2024, Senhwa Biosciences enrolled the first subject for a Phase I/II trial at Penn State Health Children’s Hospital to evaluate the efficacy of silmitasertib (CX-4945) in conjunction with chemotherapy to treat children and young adults with relapsed or refractory solid tumours.
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