Senhwa's Pindnarulex in Combination Study with Pfizer's Talazoparib for the Treatment of Prostate Cancer Granted Approval to Initiate from Australian HREC

TAIPEI and SAN DIEGO,June 6,2022 -- Senhwa Biosciences,Inc. (TPEx: 6492),a drug development company focusing on first-in-class therapeutics for oncology,rare diseases,and novel coronaviruses,announced that it has received written approval from the Human Research Ethics Committee (HREC),Australia to begin a Phase I study evaluating Senhwa's 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 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. 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 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. 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.

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 medical needs in oncology. 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.

Visit Senhwa Biosciences website for more details: www.senhwabio.com

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