Taiwan-based clinical-stage biotechnology company Senhwa Biosciences Inc. (TPEx: 6492) has completed enrollment in a Phase 1b expansion trial evaluating its lead drug candidate, pidnarulex (CX-5461), as monotherapy in patients with advanced solid tumors.
The study enrolled heavily pretreated patients, including those with pancreatic, breast, and ovarian cancers, most of whom had received multiple prior lines of therapy. Participants had cancers harboring BRCA1/2, PALB2, or other homologous recombination deficiency-associated alterations, with a median of six prior treatments and a range of one to 14 prior regimens.
In an exploratory advanced ovarian cancer cohort of 16 patients with BRCA mutations, CX-5461 achieved a disease control rate of nearly 60%. Patients demonstrating ongoing clinical benefit may enter a protocol-defined extension phase to continue receiving CX-5461, allowing further assessment of disease control durability, long-term safety, and overall clinical benefit.
CX-5461 operates as a G-quadruplex stabilizer, targeting DNA repair-deficient tumors through a mechanism distinct from PARP inhibition. Senhwa plans to report clinical study results in the first quarter of 2027, with additional data expected to be presented at the 2026 American Society of Clinical Oncology Annual Meeting.
