Senhwa's Pidnarulex Receives US FDA Fast Track Designation for the Treatment of Solid Tumors with BRCA1/2, PALB2 and other HR Gene Mutations

TAIPEI and SAN DIEGO, Jan. 25, 2022 /PRNewswire/ -- 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 the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for Pidnarulex, a first-in-class G-quadruplex stabilizer, for the treatment of patients with breast and ovarian cancers BRCA1/2, PALB2, or other HRD mutations.   

"We are excited to receive Fast Track Designation and look forward to working closely with the US FDA to accelerate the development of Pidnarulex, aiming to bring a meaningful treatment to patients with breast and ovarian cancer whose tumors have BRCA1/2. PALB2, or other HRD mutations," said Mei-Hui Kuo, Acting Chief Executive Officer of Senhwa Biosciences. FTD expedites the review of new drugs for serious conditions to fill an unmet medical need. Through Fast Track, Senhwa is eligible to apply for Accelerated Approval and Priority Review upon reaching relevant criteria with the US FDA.

Currently, Pidnarulex is tested in a Phase 1b Open-label, Multi-center Expansion Study (in both US and Canada) to determine a tolerable dose in patients with selected solid tumors (such as Breast Cancer, Ovarian Cancer, Pancreatic Cancer and Prostate Cancer) with BRCA2 and PALB2, and Ovarian Cancer with BRCA1 and other HR gene mutations. This dose will be used in future Phase II trials.

In a previous Phase 1 trial, Pidnarulex demonstrated clinically significant and lasting benefits in patients with BRCA1/2, and PALB2 mutations and that were also resistant to platinum and other chemotherapeutics. Due to a DNA repair defect, BRCA1/2 deficient tumor cells are more sensitive to PARPi through the mechanism of synthetic lethality. However, 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.

Addressing treatment resistant tumors continues to be an unmet medical need in cancer treatment. Pidnarulex has proven human efficacy across certain tumor types by accelerating dsDNA breaks. By targeting the G-quadruplex DNA structure instead, Senhwa's Pidnarulex 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 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.

About Senhwa Biosciences

Senhwa Biosciences, Inc. is a leading clinical-stage company focused on developing first-in-class, next-generation DNA Damage Response therapeutics, 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, South Korea, and Taiwan.

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

SOURCE Senhwa Biosciences, Inc.