NEW YORK – Insilico Medicine on Thursday said the US Food and Drug Administration cleared its investigational new drug application seeking permission to begin a clinical trial of the USP1 inhibitor ISM3091.
The Hong Kong-based company expects to begin an open-label Phase I trial of ISM3091 in the US and China in July. Insilico aims to evaluate the safety, tolerability, and preliminary efficacy of ISM3091 in the study in patients with advanced solid tumors and to identify a recommended Phase II dose.
USP1 is an oncogenic driver that is involved in DNA repair processes in many cancers. In in vitro preclinical studies, ISM3091 has shown activity against BRCA1/2-mutant tumor cells, and in vivo the compound has shown potential in treating homologous repair-deficient cancers and subsets of homologous repair-proficient cancers. Insilico said it will use a biomarker strategy to select patients for treatment and monitor their outcomes in the trial.
Comparing ISM3091 to PARP inhibitors, which also exploit DNA damage mechanisms in cancer cells, Sujata Rao, Insilico's head of global clinical development, said in a statement, "Not all patients respond to [PARP inhibition], and those who do benefit often develop resistance. ISM3091 promises to be a next-generation synthetic lethal therapy with the potential to bring innovative solutions to patients with solid tumors."
ISM3091 is Insilico's first oncology program to advance to the clinical stage. The company has also filed an investigational new drug application for the drug with China's National Medical Products Administration.