NEW YORK – Prelude Therapeutics on Monday said the US Food and Drug Administration accepted its investigational new drug application for its CDK9 inhibitor PRT2527 allowing it to begin a Phase I study in solid tumors with MYC dysregulation.
The company expects to begin the dose-escalation Phase I trial before the end of the year. The study will explore PRT2527 as a monotherapy in certain MYC-altered solid tumors including sarcoma, prostate cancer, and breast cancer.
In preclinical studies of PRT2527, the drug reduced MCL1 and MYC protein levels and was efficacious in hematological malignancies and solid tumor models with MYC dysregulation.
PRT2527 is Prelude's fourth cancer candidate to enter the clinic. The Wilmington, Delaware-based company is also studying drugs that target PRMT5, MCL1, and SMARCA2.
Last month, Prelude partnered with DarwinHealth to identify biomarkers that could guide the development of its pipeline candidates and select patients for its clinical trials.