California-based drug development company Senhwa Biosciences Inc (TPEx: 6492) announced on Tuesday that National Cancer Institute (NCI), part of the US National Institutes of Health (NIH), has submitted an Investigational New Drug (IND) application for Pidnarulex (CX-5461) to the US Food and Drug Administration (FDA).

Pidnarulex has been chosen as an experimental drug in the NExT (NCI Experimental Therapeutics) cancer programme, sponsored by the NCI's Division of Cancer Treatment and Diagnosis (DCTD), for a period of five years. It is to be used in a pharmacodynamic pilot study involving patients with advanced solid tumours. Produced by Senhwa, Pidnarulex is a first-in-class small-molecule aimed at stabilising G-quadruplex (G4) structures that are frequently seen in promoters of oncogenes.

The clinical trial intends to explore the response of various biomarkers to Pidnarulex in patients with or without homologous recombination deficiency (HRD).

Pidnarulex is also considering future clinical trials for the product, along with other therapies, which include immunotherapy, antibody-drug conjugates (ADC) and PARP inhibitors (Poly ADP-ribose Polymerase inhibitors, PARPi). If these trials are carried out they will be headed by the NCI, using its medical team, scientific talent network and regulatory resources.