Senhwa Biosciences Clinical Data on Pidnarulex Accepted for 2024 ESMO Congress

TAIPEI and SAN DIEGO, July 12, 2024 – Senhwa Biosciences has announced that its innovative drug, Pidnarulex (CX-5461), has shown promising results in treating multiple solid tumors in patients with BRCA2 or PALB2 gene defects. This breakthrough has earned the drug a presentation slot at the prestigious 2024 European Society for Medical Oncology (ESMO) Congress. The selection marks a significant milestone for Senhwa Biosciences and their Canadian clinical collaborators, who have been treating terminal cancer patients that have exhausted other treatment options. These patients, despite undergoing various prior treatments, have maintained stable conditions while receiving Pidnarulex (CX-5461), indicating the drug's alignment with the current trends in precision medicine.

The clinical trial conducted for Pidnarulex (CX-5461) is an open-label, multinational, and multicenter study, which is divided into two cohorts: the Main Study Cohort and the Exploratory Cohort. The Main Study Cohort targets patients with pancreatic, breast, ovarian, and prostate cancers, specifically those with BRCA2 and/or PALB2 gene defects. Meanwhile, the Exploratory Cohort focuses on ovarian cancer patients with BRCA1 gene defects and/or other homologous recombination deficiency (HRD) genes.

The primary goal of this trial is to establish the optimal dosage for patients with these specific genetic defects. Secondary objectives include evaluating the safety and tolerability of Pidnarulex (CX-5461), assessing late-onset toxicity, analyzing antitumor activity, and observing improvements in patients' quality of life. Patients in the trial have undergone between two to ten different treatment regimens, and some are even resistant to platinum-based chemotherapy and PARP inhibitors, leaving them with limited treatment alternatives. Notably, these terminal patients have experienced tangible clinical benefits from the Pidnarulex (CX-5461) treatment.

The ESMO Congress, scheduled from September 13 to 17, 2024, in Barcelona, Spain, will feature both in-person and online participation. This event is renowned for presenting the latest advancements in cancer research and treatment, providing a crucial platform for oncology professionals and scientists to network and share their findings. Recognized as one of the top three cancer medical conferences globally, alongside ASCO and AACR, the ESMO Congress is integral to the field of oncology.

The abstract for the clinical trial of Pidnarulex (CX-5461) was prepared and submitted by the Princess Margaret Cancer Centre in Canada. This abstract will detail the drug’s efficacy in treating various solid tumors with BRCA1, BRCA2, and/or PALB2 gene defects. Expected to be available online by the end of July, the full abstract and associated data will be published on September 9.

Pidnarulex (CX-5461) is currently being applied in the treatment of breast cancer, ovarian cancer, pancreatic cancer, hematologic malignancies, and prostate cancer. As a candidate for solid tumor treatments in collaboration with the National Institutes of Health (NIH), the first stage of clinical trials is set to commence in 2024. Senhwa Biosciences is optimistic that with the diligent efforts of NIH professionals and their expansive medical network, Pidnarulex (CX-5461) will make significant advancements in combatting a diverse range of cancers.