Home / Health / Gene Trial Sees Full Patient Enrollment
Gene Trial Sees Full Patient Enrollment
26 Aug
Summary
- Pidnarulex trial enrollment for BRCA1/2 and PALB2 cancers is complete.
- Enrolled patients had a median of six prior treatments.
- CX-5461 shows promise in DNA repair-deficient cancers.
Senhwa Biosciences has announced the completion of patient enrollment for its Phase Ib expansion trial of pidnarulex (CX-5461). This investigational therapy is being studied as a monotherapy for individuals with advanced solid tumours that carry BRCA1/2 or PALB2 genetic mutations. The trial also encompasses patients with other homologous recombination deficiency (HRD)-associated genetic changes.
The cohort enrolled consists of patients with a variety of DNA repair-deficient cancers, including breast, ovarian, and pancreatic tumours. These participants had previously received a median of six treatments, with some having undergone up to 14 prior therapies. Notably, many had already been treated with standard therapies such as PARP inhibitors.
Preliminary data presented in 2026 indicated a disease control rate of nearly 60% in 16 advanced ovarian cancer patients with BRCA mutations who had previously received PARP inhibitors. CX-5461 functions as a novel G-quadruplex stabilizer, targeting tumour vulnerabilities distinct from PARP inhibition.
Further steps for the study include data review and statistical analysis, with a clinical study report expected in the first quarter of 2027. Patients showing ongoing clinical benefit may continue treatment in an extension phase to gather more long-term safety and efficacy data.
