TAIPEI and SAN DIEGO, Sep. 22, 2021 -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that their drug Pidnarulex, the 2019 PCF-Pfizer Global Challenge Awards winner, will be used in combination with Pfizer’s PARP inhibitor, Talazoparib (Talzenna), to explore potential therapy in patients with metastatic castration-resistant prostate cancer. The study will be conducted by Peter MacCallum Cancer Centre (PMCC), Senhwa’s clinical partner in Melbourne, Australia.
This Phase I trial of Pidnarulex and Talazoparib will be mainly funded by the US Prostate Cancer Foundation (PCF) and Pfizer. Senhwa will provide supplies of their study drug, Pidnarulex, in addition to some specific funding for the study.
Pfizer’s Talazoparib, an oral PARP inhibitor (PARPi), received FDA’s approval in October 2018 for the treatment of adults with deleterious or suspected deleterious germline BRCA mutation–positive, HER2-negative locally advanced or metastatic breast cancer. Talazoparib currently is in a pivotal phase 3 trial for the treatment of metastatic castration-sensitive prostate cancer
While BRCA1/2 deficient tumor cells are responsive to PARPi treatments, the development of PARPi resistance is common.
In the previous Phase I trial conducted by Canadian Cancer Trials Group (CCTG), Senhwa’s Pidnarulex demonstrated clinically significant and persist benefits in patients with specific tumor biomarkers, such as BRCA1/2, and PALB2 mutations, and who had been exposed to platinum and other chemotherapeutics.
“Pidnarulex, alone, has shown efficacy in tumor cells resistant to PARPi in the preclinical studies. When Pidnarulex was in combination with other chemotherapeutics, it even delayed the development of PARPi resistance. Therefore, we think Pidnarulex demonstrates great potential as an alternative treatment for prostate cancer patients who have acquired resistance to PARPi or other chemotherapies,” said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.
Prostate Cancer is the second most lethal cancer for men in the United States. Although nearly 70% of patients can be cured with surgery, once the cancer has metastasized, almost all patients develop into castration-resistance, with a median survival time of less than two years.