WILMINGTON, Del., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a precision oncology company, today 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 PRT12396, a mutant-selective JAK2V617F inhibitor being developed for the treatment of patients with certain myeloproliferative neoplasms (MPNs). The Company anticipates dosing the first patient by Q2 of 202 ...

Core Insights - Prelude Therapeutics has presented preclinical data on its JAK2V617F-selective JH2 inhibitors and mCALR-targeted degrader antibody conjugates at the American Society of Hematology (ASH) 67 Annual Meeting, highlighting their potential for disease modification in myeloproliferative neoplasms (MPNs) [1][2] JAK2V617F Inhibitor Program - PRT12396, a JAK2V617F-selective JH2 inhibitor, has shown robust preclinical activity, selectively inhibiting JAK2V617F while preserving wild-type JAK2 signaling, and demonstrated superior efficacy compared to ruxolitinib in multiple preclinical MPN models [2][4] - The company has completed GLP toxicology studies and plans to file an Investigational New Drug (IND) application and initiate a Phase 1 study in the first quarter of 2026 [3][4] - JAK2V617F mutation is present in approximately 95% of polycythemia vera (PV) patients, 60% of essential thrombocythemia (ET) patients, and 55% of myelofibrosis (MF) patients, making it a critical target for treatment [5][6] mCALR-targeted Degrader Antibody Conjugates - The company has introduced a novel mCALR-targeted degrader antibody conjugate (DAC) that delivers a CDK9 degrader payload selectively to malignant cells, demonstrating deep mutant-selective killing and sparing healthy hematopoietic cells [4][7] - mCALR is found in approximately 25-35% of patients with MF and ET, and recent clinical data has shown meaningful therapeutic benefits from mCALR-directed antibodies [7][8] Company Overview - Prelude Therapeutics is focused on developing innovative precision oncology medicines, with a pipeline that includes selective KAT6A degraders and JAK2V617F-selective JH2 inhibitors, aiming to address high unmet needs in cancer treatment [8]

Core Insights - Prelude Therapeutics has presented preclinical data on its JAK2V617F-selective JH2 inhibitors and mCALR-targeted degrader antibody conjugates at the American Society of Hematology (ASH) 67th Annual Meeting, highlighting their potential for disease modification in myeloproliferative neoplasms (MPNs) [1][2][4] JAK2V617F Inhibitor Program - PRT12396, a JAK2V617F-selective JH2 inhibitor, has shown robust preclinical activity, selectively inhibiting JAK2V617F while preserving wild-type JAK2 signaling, and demonstrated superior efficacy compared to ruxolitinib in multiple preclinical MPN models [2][3][6] - The company has completed GLP toxicology studies and plans to file an Investigational New Drug (IND) application and initiate a Phase 1 study in the first quarter of 2026 [3][6] - JAK2V617F mutation is present in approximately 95% of polycythemia vera (PV) patients, 60% of essential thrombocythemia (ET) patients, and 55% of myelofibrosis (MF) patients, making it a critical target for treatment [5][6] mCALR Degrader Antibody Conjugate Program - The company has introduced a novel mCALR-targeted degrader antibody conjugate (DAC) that delivers a CDK9 degrader payload selectively to malignant cells, demonstrating deep mutant-selective killing and sparing healthy hematopoietic cells [4][7] - mCALR is found in approximately 25-35% of patients with MF and ET, and recent clinical data has shown meaningful therapeutic benefits from mCALR-directed antibodies [7] Company Overview - Prelude Therapeutics is focused on developing innovative precision oncology medicines, including selective KAT6A degraders and JAK2V617F-selective JH2 inhibitors, aiming to address high unmet needs in cancer treatment [8]