Notable Labs, Ltd. announced the advancement of its volasertib Phase 2 program utilizing PPMP to enrich the study population for clinical responders. Notable is developing its lead drug asset volasertib with its proprietary PPMP for patients with relapsed/refractory acute myelogenous leukemia (r/r AML). Volasertib Phase 2 program: Summary of expected near-term clinical milestones: Volasertib IND filing: First quarter 2024; Phase 2 program initiation: Second quarter 2024; Prelude data on dose optimization: Fourth quarter 2024; Enrollment of first PPMP-selected patient: Fourth quarter 2024.

Volasertib is a PLK-1 inhibitor with demonstrated activity in AML and other tumor types, including solid tumors, with significant unmet medical need. Building on the performance of volasertib on PPMP, an important and proprietary step during Notable?s targeted in-licensing strategy and decision making, Notable will utilize PPMP to predict volasertib-responsive patients prior to their treatment, with the goal of selectively enrolling and treating those predicted responders, increasing volasertib?s response rates and overall patient outcomes, and fast-tracking volasertib?s remaining clinical development in this patient population. Volasertib was originally developed and manufactured by Boehringer Ingelheim and previously granted breakthrough therapy designation by the FDA.

Notable in-licensed volasertib and obtained exclusive worldwide development and commercialization rights, except for certain rare pediatric cancers.