Voruciclib

INDICATION / COMBINATION

Chronic Lymphocytic Leukemia

Relapsed/refractory del(17p)
Venclexta™ (venetoclax)
Pre-Clinical
Clinical Proof-Of-Concept
Pivotal

In September 2017, we entered into an exclusive worldwide license, development, manufacturing and commercialization agreement with Presage for Voruciclib, an oral and selective cyclin-dependent kinase (CDK) inhibitor. Under the terms of the agreement, Presage granted us exclusive worldwide rights to develop, manufacture and commercialize Voruciclib.  We are solely responsible for the global development and commercialization of products and are solely responsible for the costs related thereto.  We will pay Presage near-term payments of up to $2.9 million and additional potential payments of up to $181 million upon the achievement of certain development, regulatory and commercial milestones.  Presage will also receive mid-single-digit tiered royalties on the net sales of product successfully developed. 

Voruciclib is a selective CDK inhibitor differentiated by its potent inhibition of CDK9. Voruciclib (formerly P1446A) has been tested in more than 70 patients in multiple Phase 1 studies and has been associated with manageable side effects consistent with other drugs in its class, including nausea, vomiting and diarrhea.  In pre-clinical studies, Voruciclib alone induces cell death in multiple patient-derived chronic lymphocytic leukemia (CLL) samples. In addition, in preclinical studies, Voruciclib shows dose-dependent suppression of MCL1 at concentrations achievable with doses that appeared to be generally well tolerated in the Phase 1 studies. Studies have shown that MCL1 is an established resistance mechanism to the B-cell lymphoma 2 (BCL2) inhibitor venetoclax (marketed as Venclexta™). We are now preparing to initiate a Phase 1/2 clinical study of Voruciclib as a single agent and  in combination with venetoclax in refractory CLL.

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