24 January 2022 - Senhwa Biosciences announced today that the US FDA has granted fast track designation for Pidnarulex, a first in class G quadruplex stabiliser, for the treatment of patients with breast and ovarian cancers BRCA1/2, PALB2, or other HRD mutations.
Currently, pidnarulex is tested in a Phase 1b open label, multicentre expansion study (in both US and Canada) to determine a tolerable dose in patients with selected solid tumours with BRCA2 and PALB2, and ovarian cancer with BRCA1 and other HR gene mutations.