TAIPEI, Aug. 25, 2026 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492) today announced that it has completed enrollment in its Phase 1b expansion trial evaluating pidnarulex (CX-5461) monotherapy in patients with advanced solid tumors harboring BRCA1/2, PALB2, or other homologous recombination deficiency (HRD)-associated alterations. With enrollment complete, the study will proceed to data review and reconciliation, database lock, and comprehensive statistical analysis. The Clinical Study Report (CSR) is expected in the first quarter of 2027.
The final analysis is expected to inform decisions on indication prioritization, biomarker-based patient selection, potential combination strategies, and the next stage of CX-5461's clinical development. The findings may also support Senhwa's global licensing and strategic partnering efforts.
Patients who continue to derive clinical benefit at the end of the main treatment period, as determined by investigators, may enter the protocol-defined extension phase and continue receiving CX-5461. Ongoing treatment and follow-up will provide additional data on the durability of disease control, longer-term safety, and overall clinical benefit.
The Phase 1b trial evaluates CX-5461 monotherapy in heavily pretreated patients with advanced DNA repair-deficient solid tumors. Enrolled tumor types include pancreatic, breast, and ovarian cancers. Patients had received a median of six prior lines of therapy (range, 1-14), and most had received multiple standard-of-care treatments, including PARP inhibitors. This population has limited treatment options and substantial unmet medical need.
"Completing enrollment marks an important clinical milestone for the CX-5461 Phase 1b expansion trial," Senhwa said. "Our focus now is on data reconciliation, database lock, and comprehensive statistical analysis to assess the safety, antitumor activity, durability of disease control, and overall clinical benefit of CX-5461 in this heavily pretreated population. These mature data will inform our next clinical development steps."
PARP inhibitors remain central to the treatment of homologous recombination deficiency (HRD)-associated cancers, including ovarian, breast, pancreatic, and prostate cancers.
HRD and DNA damage response (DDR) remain major areas of development in precision oncology. However, many patients eventually develop resistance to PARP inhibitors or experience disease recurrence, underscoring the need for effective later-line treatment options.
CX-5461 is a first-in-class G-quadruplex stabilizer designed to exploit vulnerabilities in DNA repair-deficient tumors through a mechanism distinct from PARP inhibition. Preliminary data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting showed that, in an exploratory advanced ovarian cancer cohort led by Dr. Amit Oza, CX-5461 achieved a disease control rate of nearly 60% among 16 patients with BRCA mutations, all of whom had previously received PARP inhibitor therapy.
These preliminary findings indicate antitumor activity in a heavily pretreated population and support further evaluation of CX-5461 as a potential later-line option, including for patients previously treated with PARP inhibitors. They also provide a clinical rationale for evaluating CX-5461 in combination with PARP inhibitors, immunotherapies, antibody-drug conjugates, and other precision oncology agents.
As the HRD treatment landscape moves beyond PARP inhibitor monotherapy toward resistance-overcoming and biomarker-driven combinations, Senhwa believes CX-5461's differentiated mechanism and emerging clinical data may support its use in future HRD/DDR combination regimens.
About Senhwa Biosciences
Senhwa Biosciences, Inc. is a Taiwan-based clinical-stage biotechnology company developing novel oncology therapies for cancers with significant unmet medical needs. Its pipeline includes CX-5461 and CX-4945, which are being evaluated in solid tumors and hematologic malignancies through global clinical and research collaborations. For more information, visit:
https://www.senhwabio.com
SOURCE Senhwa Biosciences, Inc.
