TAIPEI, Taiwan and SAN DIEGO, CA, USA I October 31, 2022 I Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced today that their first patient has been successfully dosed, in a phase I clinical study evaluating the combined treatment with Senhwa’s Pidnarulex, the 2019 PCF-Pfizer Global Challenge Awards winner and Pfizer’s PARP inhibitor, Talazoparib (Talzenna), in patients with metastatic castration-resistant prostate cancer(mCRPC). 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 specific funding for the study.

In 2020, US FDA granted approval of the use of PARP inhibitors (PARPi), such as olaparib (Lynparza) and rucaparib (Rubraca), to treat prostate cancer patients, whose tumors have specific genetic alterations. The most common gene alterations in this population were BCRA1/2. While BRCA1/2 deficient tumor cells are responsive to PARPi treatments, the development of PARPi resistance is common.

In a previous Phase I trial, Pidnarulex demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers, such as BRCA1/2 and PALB2 mutations and that were also resistant to PARP inhibitors, platinum-based drugs and other chemotherapeutics.

“Pidnarulex, alone, has shown efficacy in tumor cells resistant to PARPi in the preclinical studies. 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. Jin-Ding Huang, Chief Executive 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 (a form of advanced prostate cancer in which the cancer no longer completely responds to treatments that lower testosterone), with a median survival time of less than two years.

About Pidanrulex (CX-5461)

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by Pidnarulex through a synthetic lethality approach by targeting the DNA repair defects in Homologous Recombination Deficiency (HRD) tumors.  Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells which leads to disruption of the cell’s replication fork.  While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death.

About Senhwa Biosciences

Senhwa Biosciences, Inc. is a drug development company focusing on the innovation of first-in-class DNA Damage Response therapeutics and addressing unmet oncological medical needs. Headquartered in Taiwan, with an operational base in San Diego, California, Senhwa is well-positioned to oversee the development of its compounds.

Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action as anti-cancer drugs for the treatment of multiple indications, are the core products in Senhwa Bioscience’s pipeline. Clinical trials are currently ongoing in Australia, Canada, United States, Korea, and Taiwan.

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SOURCE: Senhwa Biosciences