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Notable Labs to Study Volasertib in Phase II AML Trial

NEW YORK – Notable Labs on Thursday said it will begin a Phase II clinical trial of the PLK1 inhibitor volasertib in patients with relapsed or refractory acute myeloid leukemia, using its predictive precision medicine platform (PPMP) to identify best responders.

Boehringer Ingelheim had investigated volasertib in clinical trials as a treatment for hematologic malignancies, including in patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, and acute myeloid leukemia. Foster City, California-based Notable licensed volasertib from Oncoheroes in 2021 based on a post hoc analysis of Phase II and Phase III clinical trials conducted by Boehringer Ingelheim in patients with acute myeloid leukemia in which PPMP identified responders and non-responders.

The PPMP platform analyzes how patients' cancer cells respond to treatments ex vivo and translates the findings to predictive algorithms using machine learning. Notable has previously used its PPMP platform within a Phase Ib/IIa trial of CicloMed's fosciclopirox in AML.

In a statement, Notable CEO Thomas Bock said that PPMP's "100 percent accurate prediction of fosciclopirox's clinical trial outcome" has validated the company's PPMP-guided development strategy and allowed it to eliminate a 30-patient cohort from the planned volasertib program.

"We therefore believe that PPMP will focus volasertib's development on clinically responding patients, boost its clinical response rate, and enhance patient outcomes," Bock added. "The open-label design of our Phase II trial will enable us to provide frequent data updates and initiate a subsequent Phase III trial at the earliest possibility."

Notable expects to file an investigational new drug application for the volasertib program during the first quarter of this year and begin enrolling the first PPMP-selected patient into a Phase II trial in Q4.

In that upcoming trial, Notable researchers will evaluate volasertib with the chemotherapy drug decitabine in patients with relapsed or refractory AML. The firm is aiming to confirm the tolerability profile seen in its post hoc analysis of Phase III trial data and evaluate volasertib's clinical benefit in patients based on PPMP testing of blood and bone marrow samples. Additional endpoints include the positive predicted response rate, complete remission, and overall survival. Investigators will conduct a dose-optimization study ahead of the main study in a small, all-comers cohort of patients with relapsed or refractory AML and evaluate standardized best supportive care and body surface area-based dosing.