California-based Notable Labs is hoping for success as it launches a Phase II trial of Boehringer Ingelheim’s failed candidate volasertib in patients with relapsed/refractory acute myelogenous leukemia (r/r AML).

Notable is using its Predictive Precision Medicine Platform (PPMP) to advance a Phase II trial by enriching the study population to patients most likely to respond to the candidate, eliminating a 30-patient cohort from the trial. The PPMP uses artificial intelligence (AI) and machine learning (ML) to predict how likely a patient is to respond to the candidate.

Notable Labs CEO Dr Thomas Bock, said that the technology will reduce the risk, time and cost of drug development while improving patient outcomes.

The Phase II open-label study will combine volasertib and decitabine in r/r AML. Investigators are looking to optimise the tolerability of the candidate and evaluate efficacy on the selectively enrolled patients who are predicted to respond, based on blood or bone marrow samples.

The Phase II trial is due to initiate in the second quarter of 2024, with the first patients enrolled by the end of the year.

Notable plans to conduct Phase II and Phase III trials of the candidate in AML, as well as other cancer indications shown to be likely to respond with the help of the PPMP.

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Volasertib was being developed by Boehringer Ingelheim but the company discontinued the product after failing a Phase III study in AML, licensing the full rights to the candidate in a partnership with Oncoheroes Biosciences. Oncoheroes Biosciences partnered with Notable Labs in November 2021 to continue the development of the candidate using the PPMP technology.

Volasertib is a polo-like kinase 1 (Plk1) inhibitor. It targets PLK1 which is overexpressed in hepatoblastoma biopsies, and prevents the progression of mitosis.

AML landscape

AML is an aggressive disease which is difficult to treat. The prognosis for patients is generally poor, with a low five-year survival rate.

Bone marrow transplant is currently the only curative treatment available, but it is limited to patients who are fit enough to undergo the procedure, as well as those with difficulties such as rejection or infection.

As a result, there is a significant unmet need for effective and well-tolerated treatments for AML.

According to GlobalData, the market value for AML is expected to reach $4.5bn in the 8MM (US, 5EU, Japan, and China) by 2029.

GlobalData is the parent company of Clinical Trials Arena.