On November 15, 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 an abstract highlighting clinical design for their lead drug candidate, Pidnarulex (CX-5461), in patients with solid tumors and BRCA2 and/or PALB2 mutation, has been accepted for trial in progress poster presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (2022 ASCO (Free ASCO Whitepaper) GI) in San Francisco, 20-22 January, 2022 (Press release, Senhwa Biosciences, NOV 15, 2021, View Source [SID1234595651]).
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Inherited mutations in BRCA genes predispose to various early onset cancers. Approximately 10% and 19% of pancreatic cancer patients harboring BRCA1 and BRCA2 mutations respectively and FDA has approved Lynparza (olaparib), the first poly ADP-ribose polymerase inhibitor (PARPi) as frontline maintenance in pancreatic cancer in late 2019. Unfortunately, resistance to PARPi associated with multiple mechanisms can be observed over time, suggesting a prominent unmet need for the development of new treatment options.
"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 believe Pidnarulex demonstrates great potential as a treatment for pancreatic or other cancer patients who have acquired resistance to PARPi or other chemotherapies," said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.
The full abstract will be made available online via View Source at 5:00 PM (EST) on 18 January, 2022.
About Pidnarulex (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 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. On the other hand, PMCC postulates a different mechanism of action. Specifically, it is thought that Pidnarulex acts as a RNA Pol I Inhibitor.