Prelude Therapeutics Incorporated announced that the U.S. Food and Drug Administration (FDA) cleared the company to proceed with a Phase 1 study under its Investigational New Drug Application (IND) for PRT3789, a potential cancer drug.
The Wilmington-area company anticipates dosing the first patient in the first quarter of 2023.
The Phase 1 study of PRT3789 will enroll patients with advanced solid tumors with types of mutations. The trial will be enriched for patients with non-small cell lung cancer, where certain mutations are frequently present.
The endpoints of the study include safety, tolerability, and the establishment of a recommended phase two dose with additional evaluation.
“Clearance of the IND for PRT3789 represents a major milestone for Prelude Therapeutics, as we advance our first-in-class SMARCA2 protein degrader from discovery to the clinic. There is a significant need for treatment options for patients with cancers carrying genetic alterations in SMARCA4 (BRG1) because these patients do not generally present with other targetable oncogenic drivers. While the field is evolving around SMARCA mutations, early observations indicate that patients with SMARCA mutations have aggressive disease with an urgent need for more therapies. Patients with specific SMARCA4 loss of function mutations can be easily identified with standard next-generation sequencing panels and understanding how to best identify the patients who will benefit the most from PRT3789 will be investigated in the Phase 1 study,” said Dr. Jane Huang, president and chief medical officer of Prelude.
Prelude is a clinical-stage precision oncology company developing drug candidates targeting critical cancer cell pathways.
