WILMINGTON, DE — Prelude Therapeutics (Nasdaq: PRLD) presented encouraging interim results from its Phase 1 trial of PRT2527, an investigational CDK9 inhibitor, at the 66th American Society of Hematology Annual Meeting. The trial is evaluating PRT2527 as a monotherapy and in combination with zanubrutinib in patients with relapsed or refractory lymphoid malignancies.
The study enrolled 46 patients, with 29 receiving PRT2527 monotherapy and 17 treated in combination with zanubrutinib. PRT2527 demonstrated a manageable safety profile with most common side effects being neutropenia (48%) and nausea (33%). No treatment-emergent adverse events (TEAEs) led to discontinuation in the combination cohort, though some dose interruptions due to neutropenia were managed with growth factor support.
Jane Huang, M.D., President and Chief Medical Officer of Prelude, noted the potential of CDK9 inhibition in treating hematologic cancers. “We are encouraged by the results demonstrated to date by PRT2527 both as a monotherapy and particularly in combination with zanubrutinib, resulting in an overall response rate of 38.5%, including patients with aggressive lymphomas previously treated with CAR-T therapy.”
Preliminary efficacy data showed a 17.4% response rate in the monotherapy cohort, including one complete response in a patient with diffuse large B-cell lymphoma (DLBCL) and three partial responses in patients with T-cell lymphomas. The combination cohort demonstrated a stronger response, with an overall rate of 38.5%, including three complete responses and two partial responses across different lymphoid malignancies.
Prelude’s CEO, Kris Vaddi, Ph.D., emphasized the significance of PRT2527’s results while outlining future priorities. “These findings confirm our hypothesis that a selective and potent CDK9 inhibitor offers meaningful clinical activity for hematologic malignancies while reducing off-target toxicities,” said Vaddi. With a focus on its SMARCA degrader programs, Prelude intends to seek a partner for the CDK9 program following the completion of its Phase 1 study.
The company will continue advancing its other promising drug development initiatives while exploring collaboration opportunities to further develop PRT2527.
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