Tolero, AbbVie to explore venetoclax alvocidib combo for AML

Tolero Pharmaceuticals said that its cyclin-dependent kinase 9 (CDK9) inhibitor alvocidib will be combined with AbbVie leukemia drug venetoclax to evaluate their potential in their treatment of relapsed/refractory acute myeloid leukemia (AML).

In this regard, the two companies have entered into a clinical research collaboration while retaining full commercial rights for their respective drugs.

According to Tolero Pharmaceuticals, alvocidib controls the expression of a survival factor, MCL-1. Venetoclax, on the other hand, is a small molecule inhibitor of B-cell lymphoma-2 (BCL-2).

MCL-1 and BCL-2 are considered to be key proteins utilized by certain cancer cells to avoid apoptosis.

Cancer cells can resist inhibition of BCL-2 by utilizing MCL-1 to avoid cell death as per non-clinical studies, said Tolero Pharmaceuticals. Currently, alvocidib is in phase II development for the treatment of MCL-1-dependent AML.

AbbVie, Tolero to study venetoclax alvocidib combo for acute myeloid leukemia.

AbbVie, Tolero to study venetoclax alvocidib combo for acute myeloid leukemia. Photo courtesy of AbbVie Inc.

David J. Bearss – CEO of Tolero Pharmaceuticals said: “We are very pleased to announce our clinical research collaboration with AbbVie, as it marks an important step in the development of this novel agent for patients with relapsed/refractory AML.

“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/refractory AML.”

As per the terms of the agreement, Tolero Pharmaceuticals and AbbVie will bear the development expenses on a 50:50 basis.

Neil Gallagher – Vice President, Head of Global Oncology Development, AbbVie, said: “This is a unique opportunity to bring together and investigate two first and only in class compounds to help patients with AML.

“There is an urgent need for new therapies, particularly in patients who either did not respond well to initial therapy or who subsequently relapsed. AML is a complex disease at the cellular level. Therefore, combining alvocidib with venetoclax, which have distinct but potentially complementary mechanisms for targeting the leukemia cells, makes a lot of sense from a scientific perspective.”

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