Taiwan-based Senhwa Biosciences Inc. (TPEx: 6492) has completed enrollment in a Phase 1b expansion trial evaluating its experimental cancer drug pidnarulex (CX-5461) as monotherapy in patients with advanced solid tumors harboring BRCA1/2, PALB2 or other homologous recombination deficiency-associated alterations.
The trial enrolled heavily pretreated patients with advanced DNA repair-deficient solid tumors, including pancreatic, breast and ovarian cancers. Participants had received a median of six prior lines of therapy, ranging from one to 14 prior treatments, with most having undergone multiple standard-of-care regimens, including PARP inhibitors.
Following enrollment, the study will proceed to data review, database lock and statistical analysis, with a Clinical Study Report expected in the first quarter of 2027. Patients demonstrating clinical benefit may enter a protocol-defined extension phase to continue receiving CX-5461, enabling further assessment of disease control durability, long-term safety and overall clinical benefit.
CX-5461 is a G-quadruplex stabilizer designed to target DNA repair-deficient tumors through a mechanism distinct from PARP inhibition. Preliminary data presented at the 2026 American Society of Clinical Oncology Annual Meeting showed a disease control rate of nearly 60% among 16 patients with BRCA mutations in an exploratory advanced ovarian cancer cohort, all of whom had previously received PARP inhibitor therapy. Senhwa’s pipeline includes CX-5461 and CX-4945, which are under evaluation in solid tumors and hematologic malignancies.
