Prelude Therapeutics Receives FDA Clearance of Investigational New Drug Application (IND) for PRT12396, a Mutant-selective JAK2V617F Inhibitor

Core Insights - Prelude Therapeutics has received FDA clearance to proceed with a Phase 1 study for PRT12396, a mutant-selective JAK2V617F inhibitor aimed at treating myeloproliferative neoplasms (MPNs) [1][2] - The company plans to begin dosing the first patient by Q2 of 2026, marking a significant milestone in its strategic focus on JAK2 and KAT6 programs [2] Company Developments - The Phase 1 study will be an open-label, multi-center trial assessing safety, efficacy, and pharmacokinetics in patients with high-risk polycythemia vera (PV) and intermediate to high-risk myelofibrosis (MF) [2] - Prelude's JAK2V617F inhibitor program is under an exclusive option agreement with Incyte, which was announced in November 2025 [3] Scientific Background - JAK2V617F is a key mutation affecting approximately 95% of patients with polycythemia vera, 60% of those with essential thrombocythemia, and 55% of myelofibrosis patients [4] - Prelude has developed novel allosteric inhibitors that specifically target V617F+ cells, which may reduce mutant allele burden and improve treatment outcomes for MPN patients [4] Company Overview - Prelude Therapeutics is focused on precision oncology, developing innovative medicines for cancer patients with high unmet needs [5] - The company's pipeline includes selective KAT6A degraders and JAK2V617F inhibitors, aiming to leverage targeted protein degradation for next-generation therapies [5]