Benzinga | Sep 30, 2020 07:14AM EDT

Prelude Therapeutics Announces Dosing of First Patient in Phase 1 Trial of MCL1 Inhibitor PRT1419 for the Treatment of Relapsed/Refractory Hematologic Malignancies

Prelude Therapeutics Incorporated (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced that the first patient has been dosed in its first-in-human Phase 1 open-label, multicenter, dose-escalation study of PRT1419 in patients with relapsed/refractory hematologic malignancies. PRT1419, the Company's third clinical candidate, is designed to be an orally available, potent and selective MCL1 inhibitor.

The dose escalation portion of the study will be conducted across two groups, including in patients with relapsed/refractory high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) (Group A), as well as patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (Group B). The dose expansion portion of the trial will evaluate either monotherapy PRT1419 or, for a cohort of patients with AML or MDS, in combination with existing standards of care. The primary objectives of the study will seek to identify dose-limiting toxicities, a maximum tolerated dose, and a recommended Phase 2 dose. Secondary objectives will assess the safety and tolerability, pharmacokinetic profile, and anti-tumor activity of PRT1419.