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Prelude Therapeutics Announces IND Clearance for PRT2527, a Highly Selective CDK9 Inhibitor
Phase 1 Clinical Trial in Patients with Selected Solid Tumors Anticipated to Begin by Year-End WILMINGTON, Del., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Prelude
About this update from Prelude Therapeutics Incorporated
[{"type":"text","content":"Phase 1 Clinical Trial in Patients with Selected Solid Tumors Anticipated to Begin by Year-End\nWILMINGTON, Del., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for its precision oncology candidate, PRT2527, which is designed to be a potent and selective CDK9 inhibitor. Prelude anticipates beginning a Phase 1 clinical trial of PRT2527 by year-end evaluating escalating doses of intravenous (IV) PRT2527 as a monotherapy in patients with selected solid tumors, including sarcoma, prostate cancer, breast cancer, and other cancers with genomic alterations that lead to MYC dependence. In preclinical studies, PRT2527 was shown to reduce MCL1 and MYC protein levels and was highly active in preclinical models at well-tolerated doses. PRT2527 has demonstrated high potency and kinase selectivity which may offer improved efficacy and safety compared to less selective CDK9 inhibitors. Preclinical data presented in October 2021 at the annual AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics demonstrated that treatment with PRT2527 depleted oncogenic drivers with short half-lives, such as MYC and MCL1, and effectively induced apoptosis. PRT2527 treatment demonstrated robust efficacy in both hematological malignancies and solid tumor models with MYC dysregulation. “Utilizing our internal discovery engine and expertise, we are focused on developing and advancing differentiated, optimal small molecule therapeutics to treat highly underserved patients with difficult to treat cancers. Our precision oncology approach seeks to identify those cancers vulnerable to mechanisms targeted by our product candidates, in the hopes of providing new options in the battle against these devastating diagnoses. I’m proud of the achievements of our Prelude team, as we now advance our fourth oncology candidate into clinical development. We look forward to providing updates on PRT2527 and our other clinical development programs in 2022,” said Kris Vaddi, PhD, Chief Executive Officer. About Prelude Therapeutics Prelude Therapeutics is a clinical-stage precision oncology company developing innovative, potential best-in-class...