Senhwa Biosciences has completed enrolment in its Phase Ib expansion trial of pidnarulex (CX-5461) as a monotherapy for people with advanced solid tumours carrying breast cancer gene 1/2 (BRCA1/2) or partner and localiser of BRCA2 (PALB2).
The trial also includes patients with other homologous recombination deficiency (HRD)-associated genetic changes.
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Further steps for the study include data review, database lock, and full statistical analysis, with a clinical study report (CSR) anticipated in the first quarter of 2027.
The completed trial cohort comprises patients with a range of advanced, deoxyribonucleic acid (DNA) repair-deficient cancers, including breast, ovarian, and pancreatic tumours.
Those enrolled had received a median of six prior treatments, with a range from one to 14 previous therapies.
Many had already been treated with standard therapies, including poly (ADP-ribose) polymerase (PARP) inhibitors, a class of drugs central to managing HRD‑related cancers such as ovarian, prostate, breast, and pancreatic tumours.
Participants demonstrating ongoing clinical benefit at study conclusion, as decided by investigators, are eligible to continue on CX-5461 in a defined extension phase.
The extended use aims to provide further details regarding disease control duration, long-term safety, and overall benefit.
CX-5461 is described as a first-in-class G-quadruplex stabiliser, developed to target vulnerabilities in tumours with deficiencies in DNA repair through a mechanism distinct from PARP inhibition.
Preliminary data, reported at the 2026 American Society of Clinical Oncology Annual Meeting, indicated a disease control rate near 60% among 16 advanced ovarian cancer patients with BRCA mutations who had previously been treated with PARP inhibitors.
Senhwa Biosciences develops novel cancer therapies and advances a pipeline that includes CX-5461 and CX-4945 targeting solid tumours and haematological malignancies.
In November 2024, the company enrolled the first subject for a Phase I/II trial at Penn State Health Children’s Hospital to evaluate the efficacy of silmitasertib (CX-4945) in conjunction with chemotherapy to treat children and young adults with relapsed or refractory solid tumours.
