Senhwa Biosciences Inc (TPEx: 6492), a Taiwan-based clinical-stage biopharmaceutical company, announced on Thursday that it has signed a clinical supply agreement with BeOne Medicines, a US-based global oncology company.

This agreement covers a global, multi-centre Phase 1b/2a clinical trial to assess Senhwa's lead compound Pidnarulex (CX-5461) in combination with BeOne's tislelizumab, a PD-1 inhibitor, in patients with advanced solid tumours, including pancreatic ductal adenocarcinoma (PDAC) and immune checkpoint inhibitor (ICI)-refractory melanoma.

BeOne Medicines will supply tislelizumab for the combination study, while Senhwa will provide CX-5461 and lead clinical and regulatory operations. The study will enrol patients at multiple sites in the United States and Taiwan, evaluating safety, tolerability, and preliminary efficacy of the CX-5461 and tislelizumab combination.

CX-5461 was discovered and developed by Senhwa Biosciences Inc. Recent preclinical and clinical findings suggest that CX-5461 not only exerts direct cytotoxic activity but also modulates the tumour microenvironment, enhancing immune recognition and response.