Senhwa Biosciences Submits IND for Pidnarulex in NCI-Sponsored Advanced Tumour Trial
Wednesday, September 18, 2024
Senhwa Biosciences has announced that an Investigational New Drug (IND) application for its experimental therapy, Pidnarulex (CX-5461), has been submitted to the U.S. FDA.
Pidnarulex is a first-in-class small molecule that works by stabilising G-quadruplex (G4) structures, which are linked to oncogenes. By disrupting replication, it induces DNA damage, leading to cancer cell death.
The application was made by the National Cancer Institute (NCI) under the NCI Experimental Therapeutics (NExT) programme, which will see Pidnarulex used in a pharmacodynamic study on patients with advanced solid tumours.
The trial aims to investigate the drug's effects on various biomarkers in patients, with and without homologous recombination deficiency (HRD).
This mechanism suggests Pidnarulex could offer promising treatment options for multiple cancer types.
In addition to the monotherapy study, the NCI is exploring future clinical trials combining Pidnarulex with other therapies, including immunotherapy, antibody-drug conjugates (ADC), and PARP inhibitors.
If pursued, these trials will be led by the NCI, using its medical expertise and resources to accelerate the development and potential market introduction of Pidnarulex.
Immunotherapy and ADCs are rapidly growing areas in cancer treatment. The ADC market is projected to reach $30 billion by 2028, while the global cancer immunotherapy market is expected to exceed $224 billion by 2030. As only a small percentage of patients respond effectively to immunotherapy alone, combination therapies are being increasingly explored as a way to improve outcomes.
With this in mind, Senhwa remains optimistic about the future development of Pidnarulex in combination with these therapies.
Source: senhwabio.com
