Taiwan’s clinical-stage biotechnology firm Senhwa Biosciences Inc. has completed patient recruitment for a Phase 1b expansion trial evaluating pidnarulex (CX-5461) as monotherapy in advanced solid tumors with DNA repair deficiencies.
The trial enrolled patients whose cancers carried alterations in BRCA1/2, PALB2 or other homologous recombination deficiency-linked genes. Participants had received a median of six prior treatment lines, including PARP inhibitors, with individual histories ranging from one to 14 prior therapies. CX-5461 operates as a G-quadruplex stabilizer, targeting tumors via a mechanism distinct from PARP inhibition.
Preliminary efficacy data presented at the 2026 ASCO Annual Meeting showed that, among 16 BRCA-mutant patients in an exploratory advanced ovarian cancer cohort—all of whom had prior PARP inhibitor therapy—CX-5461 achieved a disease control rate of nearly 60%. The company plans to file a Clinical Study Report by the first quarter of 2027.
