FDA OKs Trial of Investigational Drug for Advanced Solid Tumors


This summer, a trial will kick off studying ISM3091 in patients with advanced solid tumors.

The Food and Drug Administration (FDA) green lit a phase 1 trial of ISM3091, an investigational drug for the treatment of solid tumors, according to a press release from Insilco Medicine, the manufacturer of the agent.

The trial, which will begin in cancer centers across the United States and China in July, will evaluate the safety, tolerability, movement of the drug throughout the body and potential cancer-fighting capabilities of ISM3091 in patients with advanced solid tumors. Additionally, through a dose escalation and optimization protocol, the phase 1 trial will identify the recommended dose level for a future phase 2 study.

“We are developing and evaluating ISM3091, a potent and highly selective small molecule inhibitor of USP1, as a target anticancer agent,” said Dr. Sujata Rao, head of global clinical development at Insilico Medicine, said in a press release. “PARP inhibitors are the first clinically approved drugs designed to exploit synthetic lethality, which have demonstrated positive clinical treatment effects. However, not all patients respond to (PARP inhibitors), 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 — which is taken orally — works by inhibiting USP1, a protein-coding gene that plays an important part in DNA damage response and repair. According to research published in 2019 in the journal Frontiers in Oncology, elevated USP1 levels were found to be associated with shorter overall survival (time from treatment until death of any cause) in patients with advanced cancers.

In preclinical studies (meaning that the research was not conducted on humans), ISM3091 was efficacious in treating multiple types of solid tumors, including those with BRCA mutations and those that were homologous recombination proficient. The drug also had a high margin of safety.

“ISM3091 is Insilico’s third internal program to advance to the clinical stage. We are pleased to see that it has demonstrated promising safety profiles and efficacy features in preclinical,” said Feng Ren, co-CEO and chief scientific officer of Insilico Medicine, in the release.

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