Notable Enhances Volasertib Phase 2 with Predictive Medicine Platform

Notable Labs, a clinical-stage company, is leveraging its Predictive Precision Medicine Platform (PPMP) to enhance its volasertib Phase 2 program for patients with relapsed/refractory acute myeloid leukemia (r/r AML), a condition with a pressing medical need characterized by low treatment response rates and short median survival times. The PPMP has demonstrated a 100% accuracy rate in predicting clinical trial outcomes, enabling Notable to refine its drug development strategy to target patients more likely to respond, thereby reducing risks and development costs.
The company anticipates initiating the Phase 2 trial in the second quarter of 2024, with preliminary data expected by the fourth quarter of the same year. Notable acquired volasertib due to its established clinical profile and the PPMP's ability to differentiate potential responders from non-responders. The open-label Phase 2 trial design will facilitate frequent data updates and a rapid transition to a Phase 3 trial if successful.
Dr. Joseph Wagner, Notable's Chief Scientific Officer, highlighted that the Phase 2 trial will incorporate insights from a comprehensive analysis of previous trials, focusing on standardizing care and adjusting dosing based on body surface area to improve patient responses. A dose optimization study is planned for the second quarter of 2024, with results due by the fourth quarter.
The volasertib Phase 2 program includes a non-selective dose optimization prelude, aiming to assess the efficacy of standardized care and dosing in a small group of patients before PPMP-based patient selection begins. The trial's primary endpoints will measure the predicted response rate and the clinical impact on PPMP-predicted responders.
Volasertib, a PLK-1 inhibitor, has shown activity against AML and other tumors, including solid cancers. Notable plans to use PPMP to identify patients likely to respond to volasertib, with the goal of increasing its response rate and overall patient outcomes. The drug was originally developed by Boehringer Ingelheim and has received breakthrough therapy designation from the FDA. Notable holds exclusive worldwide development and commercialization rights, except for certain pediatric cancers.
Notable Labs is committed to developing predictive precision medicines for cancer patients. Its PPMP aims to predict a patient's response to specific treatments, potentially accelerating clinical development. The company's strategy is to deliver medical and commercial value more quickly and with a higher chance of success than traditional drug development methods. Notable Labs is headquartered in Foster City, California, and is dedicated to transforming the standard of care and making a significant positive impact on patients and the healthcare community.