Notable Advances Volasertib Phase 2 Program Utilizing Proprietary Predictive Precision Medicine Platform-Guided Enrollment

• Predictive Precision Medicine Platform (PPMP) utilized to enrich program for clinically responding patients and reduce the risk, time, and cost of drug development
• Volasertib Phase 2 trial initiation in relapsed/refractory acute myeloid leukemia anticipated in Q2 2024, and first data in Q4 2024
• Relapsed/refractory acute myeloid leukemia constitutes an urgent unmet medical need with typical treatment response rates of 15 percent and a median survival of 6 months or less
  

FOSTER CITY, Calif., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Notable Labs, Ltd. (Nasdaq: NTBL) (“Notable”, “Notable Labs”), a clinical-stage therapeutics platform company developing a new class of cancer therapies based on its Predictive Precision Medicine Platform (PPMP), today 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).

“PPMP’s recently reported, 100% accurate prediction of fosciclopirox’s clinical trial outcome has allowed us to eliminate an entire 30-patient cohort from the planned volasertib program, and further validated our PPMP-guided development strategy to target responding patients, improve patient outcomes and reduce the risk, time, and cost of drug development,” said Thomas Bock, M.D., Chief Executive Officer of Notable Labs.

“We in-licensed volasertib because of its robust clinical experience in Boehringer Ingelheim’s expansive Phases 1-3 program and our PPMP data that distinguished predicted volasertib-responders from predicted non-responders based on samples from patients with AML. We therefore believe that PPMP will focus volasertib’s development on clinically responding patients, boost its clinical response rate and enhance patient outcomes,” continued Dr. Bock. “The open label design of our Phase 2 trial will enable us to provide frequent data updates, and initiate a subsequent Phase 3 trial at the earliest possibility.”

Joseph Wagner, Ph.D., Chief Scientific Officer of Notable, added, “In our PPMP-guided Phase 2 trial, we are additionally leveraging important learnings from the extensive post-hoc analysis of the original Phase 2 and 3 trials. This analysis suggests that standardizing best supportive care and introducing body surface area-based dosing are likely to enhance patient responses and tolerability. We are going to include and evaluate these refinements in a small all-comers dose optimization prelude, expected to begin in Q2 2024 and be completed in Q4 2024, prior to enrolling PPMP-predicted responders.”