On September 10, 2021 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported 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 (Press release, Senhwa Biosciences, SEP 10, 2021, View Source [SID1234587877]).
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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.