NEW YORK – New Jersey-based PMV Pharma said earlier this week that it has dosed the first cancer patient in a Phase I/II trial of its investigational agent PC14586, which is designed to reactivate the ability of the p53 protein to suppress tumors.
The trial will enroll up to 130 patients with advanced solid tumors that have the p53 Y220C variant. In the Phase I portion of the study, researchers will evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of the drug. And in the Phase II portion, researchers will determine patients' overall response rate and duration of response to PC14586 at a dose identified in Phase I.
PC14586 is designed to target the p53 Y220C mutant protein on cancer cells and restore the normal tumor suppressing function of p53. The p53 Y220C mutation is observed in at least 30 different tumor types, including breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers. Previous research has found that the p53 Y220C mutation accounts for 1.8 percent of all p53 mutations.
"Initiating our Phase I/II study represents a significant milestone for PMV, as PC14586 is our first tumor-agnostic therapy to enter the clinic," PMV CEO David Mack said in a statement. "We look forward to the opportunity to address the significant unmet need for patients whose cancers have a p53 Y220C mutation as we advance PC14586 in the clinic."
In October, the US Food and Drug Administration granted fast track designation to PC14586. PMV is also developing another drug that targets the p53 R273H mutation, which is currently in preclinical studies.