Senhwa Biosciences Clinical Data Abstract of Pidnarulex Accepted for Presentation at 2024 ESMO Congress

TAIPEI and SAN DIEGO, July 12, 2024 /PRNewswire/ — Senhwa Biosciences’ new drug Pidnarulex (CX-5461) has demonstrated efficacy in treating various solid tumors with BRCA2 or PALB2 gene defects. The abstract of this clinical trial has been selected for presentation at the 2024 European Society for Medical Oncology (ESMO) congress. This achievement is a significant milestone for Senhwa Biosciences and the Canadian clinical team, as it includes terminal cancer patients who although have undergone various prior treatments are found in stable condition, continuously receiving Pidnarulex (CX-5461) treatment in this trial. This highlights that Pidnarulex (CX-5461) aligns with the trend of developing new drugs for precision medicine.

The clinical trial is an open-label, multinational, multicenter study, divided into a Main Study Cohort and an Exploratory Cohort. The Main Study Cohort includes patients with various tumors (pancreatic cancer, breast cancer, ovarian cancer, and prostate cancer) with BRCA2 and/or PALB2 gene defects. The Exploratory Cohort includes ovarian cancer patients with BRCA1 gene defects and/or other homologous recombination deficiency (HRD) genes. The primary objective of the trial is to determine the optimal dose for patients with specific gene defects while the secondary objectives are set to assess the safety and tolerability of Pidnarulex (CX-5461), and to evaluate late-onset toxicity, antitumor activity as well as improvement in patients’ quality of life. Patients enrolled in this clinical trial have undergone 2 to 10 different treatment regimens; some of them   are even resistant to platinum-based chemotherapy and PARP inhibitors, leaving no other treatment options available. Encouragingly, these terminal patients have shown clinical benefits provided by the Pidnarulex (CX-5461) treatment.

The 2024 European Society for Medical Oncology (ESMO) Congress will be held from September 13 to 17, 2024, in Barcelona, Spain, welcoming both in-person and online participations. This congress will showcase the latest cutting-edge cancer translational data and provide a platform for oncology professionals and scientists to network and share research and innovations. The ESMO Congress is a cornerstone event in oncology, recognized globally for its significant contributions to cancer treatment and research. It is one of the top three cancer medical conferences worldwide, alongside ASCO and AACR. The abstract for the clinical trial of Pidnarulex (CX-5461) treating various solid tumors with BRCA1, BRCA2, and/or PALB2 gene defects (1b) was written and submitted by the Canadian clinical partner, Princess Margaret Cancer Centre. The abstract title is expected to be available online by the end of July, with the full abstract and related data to be published on September 9.

Senhwa Biosciences’ new drug, Pidnarulex (CX-5461), is currently being applied in breast cancer, ovarian cancer, pancreatic cancer, hematologic malignancies, and prostate cancer. As a new drug candidate for solid tumors in collaboration with National Institutes of Health (NIH), the first stage of clinical trials will begin in 2024. With the remarkable efforts of NIH’s professionals and medical network, Senhwa Biosciences expects the clinical outcomes of Pidnarulex (CX-5461) treating multiple cancers will make significant strides in the fight against various types of cancer.

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