TAIPEI, Taiwan and SAN DIEGO, CA, USA I September 10, 2021 I 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 first patient has been successfully dosed, in a Phase 1b clinical study of Pidnarulex as a potential treatment for solid tumors with Homologous Recombination (HR) gene mutations, at the Princess Margaret Cancer Centre in Toronto, Canada.

This new Phase 1b open-label, multi-center Expansion study (in both US and Canada) was designed to determine a tolerable dose of Pidnarulex in patients with selected solid tumors with BRCA1/2, PALB2, and other HR gene mutations. This dose will be used in future Phase II trials.  

“We are very excited to begin enrollment in our Phase 1b clinical trial for evaluating Pidnarulex in patients with BRCA1/2, PALB2 and other homologous recombination gene mutations. This is an important milestone and marks a new paradigm in the treatment of cancers with specific pathogenic mutations,” stated Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

In a previous Phase 1 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 platinum and other chemotherapeutics. This past May, the American College of Medical Genetics and Genomics (ACMG) issued new guidance for patients and doctors, advising that individuals with PALB2 mutations be surveilled similarly to individuals with BRCA mutations. The experts have identified the PALB2 mutation as the third most important breast cancer gene after BRCA1 and BRCA2 mutations, as it also increases a patient’s risk of developing ovarian and pancreatic cancer.

“The new guidelines for the PALB2 mutation not only raises the public’s awareness and provides guidance regarding how to manage that risk, but also validates that our hard work is going in the right direction,” said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.

While BRCA1/2 deficient tumor cells are more sensitive to PARP inhibitor (PARPi) treatments, PARPi resistance is not uncommon in clinical use. According to an article published on Molecular Cancer in 2020, more than 40% of BRCA1/2 deficient patients fail to respond to PARPi alone. By targeting the G-quadruplex DNA structure instead, Senhwa’s Pidnarulex also has great potential as an alternative treatment for patients who have developed resistance to PAPRi or other chemotherapies.

About Pidnarulex (CX-5461)

Specific mutations within the HR pathway may be exploited by Pidnarulex through a “synthetic lethality” approach by targeting the DNA repair defects in HR Deficient 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 leading clinical-stage company focused on developing first-in-class, next-generation DNA Damage Response therapeutics for patients with 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.

Development is currently focused on two lead products, Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action as anti-cancer drugs for the treatment of multiple indications. Clinical trials are currently ongoing in Australia, Canada, United States, South Korea, and Taiwan. 

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SOURCE: Senhwa Biosciences