Tolero Pharmaceuticals and AbbVie partner to develop AML therapy

Biopharmaceutical firm Tolero Pharmaceuticals and AbbVie have formed a clinical research alliance to evaluate venetoclax and alvocidib combination for relapsed or refractory acute myeloid leukaemia (AML) treatment.

Tolero’s alvocidib is an investigational, small molecule inhibitor of cyclin-dependent kinase 9 (CDK9), that regulates the expression of a survival factor called MCL-1.

The drug candidate is currently undergoing Phase II development to treat MCL-1-dependent AML.

In partnership with Roche, AbbVie is developing venetoclax as an oral, small molecule inhibitor of the B-cell lymphoma-2 (BCL-2) protein.

MCL-1 and BCL-2 are considered important for some cancer cells to avoid apoptosis. In non-clinical studies, cancer cells were found to resist BCL-2 inhibition by utilising MCL-1 for avoiding cell death.

The new clinical trial, which will be conducted as part of Tolero Pharmaceuticals and AbbVie alliance, will investigate potential benefits of combining venetoclax and alvocidib.

Tolero Pharmaceuticals CEO David Bearss said: "Preclinical data suggest that the mechanisms of action for venetoclax and alvocidib may synergistically drive apoptosis in cancer cells.

"We hope to further investigate this hypothesis with our planned trial of this combination therapy in patients with relapsed or refractory AML."

Under the terms of the collaboration, Tolero Pharmaceuticals and AbbVie will equally share the development expenses. The companies will retain commercial rights for their respective products.

AbbVie vice-president and Global Oncology Development head Neil Gallagher said: "AML is a complex disease at the cellular level.

"Therefore, combining alvocidib with venetoclax, which have distinct but potentially complementary mechanisms for targeting the leukaemia cells, makes a lot of sense from a scientific perspective."

Currently, Venetoclax has approvals in more than 50 markets, including the US and European Union (EU). AbbVie, Roche and Genentech are working with regulatory agencies globally to provide access for eligible patients.

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