Notable Labs Gets FDA Nod for Volasertib Phase 2 Study

Notable Labs, Ltd. has announced significant advancements in their Phase 2 volasertib program after receiving the "Clearance to Proceed" from the FDA. This green light includes an agreement on the dosing plan for their Phase 2 clinical trial, aiming to develop volasertib for patients with relapsed refractory (R/R) acute myeloid leukemia (AML). The company commenced trial start-up activities earlier this year and plans to begin patient enrollment in the coming months.

Thomas Bock, M.D., CEO of Notable, expressed satisfaction with the progress of their clinical development program aimed at evaluating volasertib in combination with decitabine for R/R AML patients. The FDA's clearance and approval of the Phase 2 dosing plan allow them to proceed with activating study sites. Dr. Bock highlighted the pressing need for new treatments in AML, especially for patients whose disease has relapsed after first-line treatments and those who have undergone venetoclax-based therapies. He emphasized the significance of advancing the volasertib program, which he believes has the potential to improve patient outcomes and tolerability.

Dr. Glenn Michelson, the Chief Medical Officer of Notable, added that the study design and enrollment strategy for volasertib are informed by robust clinical validation trials conducted at prestigious institutions like Stanford University and the University of Texas MD Anderson Cancer Center. The program also benefits from insights gained from Boehringer Ingelheim's extensive analysis of an initial Phase 3 AML study. This background information was crucial in Notable's decision to in-license volasertib and formulate their development strategy.

Amer Zeidan, MBBS, Associate Professor of Medicine and Chief of Hematologic Malignancies at Yale Cancer Center, who also serves as the study co-chair, expressed optimism about volasertib's potential. He believes that the combination of Notable's platform and enhanced trial design could address some issues encountered in previous trials, ultimately advancing care for AML patients.

The Phase 2 study will initiate with a dose optimization lead-in phase, which includes body-surface area dosing, prophylactic antibiotic treatment, and best supportive care. The second part of the study aims to enroll patients with R/R AML who have been identified as likely responders by Notable’s Predictive Medicine Platform (PMP). The company plans to start dosing the first subjects in this phase soon. Notable expects initial data from the dose optimization lead-in by the fourth quarter of 2024 and plans to start selective enrollment of PMP-predicted responders thereafter, with initial efficacy results anticipated in the first half of 2025.

Volasertib, a PLK-1 inhibitor, has shown activity in AML and other tumors with significant unmet medical needs. By leveraging their PMP, Notable aims to predict which patients are most likely to respond to volasertib, thereby enhancing response rates and overall patient outcomes. Originally developed by Boehringer Ingelheim, volasertib was granted Breakthrough Therapy designation by the FDA. Notable now holds exclusive worldwide development and commercialization rights for volasertib, except for certain rare pediatric cancers.

Notable Labs, Ltd., headquartered in Foster City, California, is a clinical-stage company focused on developing predictive medicines for cancer patients. Their proprietary PMP aims to identify and select patients who are likely to respond to specific therapies, potentially expediting clinical development. Through a calculated in-licensing strategy, Notable seeks to deliver medical and commercial value more quickly and successfully than traditional drug development methods. The company is dedicated to transforming the standard of care, thereby making a significant positive impact on patients and the healthcare community.