Wed Sep 18 02:17:32 UTC 2024: ## NCI to Test Senhwa’s Cancer Drug Pidnarulex in Clinical Trials

**TAIPEI and SAN DIEGO, Sept. 17, 2024** – Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on oncology, rare diseases, and infectious diseases, announced today that the National Cancer Institute (NCI) has submitted an Investigational New Drug (IND) application to the U.S. FDA for Pidnarulex (CX-5461).

Pidnarulex, Senhwa’s first-in-class small-molecule drug, has been selected for the NCI’s NExT (NCI Experimental Therapeutics) cancer program. This five-year program will see Pidnarulex tested in a pharmacodynamic (PD) pilot study involving patients with advanced solid tumors.

The NCI is also considering future clinical trials combining Pidnarulex with other therapies, including immunotherapy, antibody-drug conjugates (ADCs), and PARP inhibitors. These trials, if realized, will be led by the NCI, leveraging its expertise and resources. This collaboration could significantly accelerate the development and expansion of indications for Pidnarulex, benefiting patients with an earlier market launch.

Pidnarulex works by stabilizing G-quadruplex (G4) structures found in oncogene promoters, leading to DNA damage and cancer cell death. The drug has the potential to treat a wide range of cancers.

The current trial, for which the IND was submitted by the NCI’s Division of Cancer Treatment and Diagnosis (DCTD), will assess the response of various biomarkers to Pidnarulex in patients with and without homologous recombination deficiency (HRD).

Senhwa is optimistic about the NCI’s plans to advance clinical trials of Pidnarulex in combination with immunotherapy and ADCs, given the growing importance of these therapies in the cancer drug market. The ADC market is expected to reach $30 billion by 2028, while the global cancer immunotherapy market will exceed $224 billion by 2030. Combination therapies are becoming increasingly crucial to address the complexities of the tumor microenvironment and enhance the efficacy of immunotherapy.

Read More