Exclusive License Agreement between MEI Pharma and Presage Bioscience

An Oncology company, MEI Pharma focusing on the clinical development of novel therapies for cancer has announced that it has entered into a license agreement with Presage Biosciences. The license agreement is signed for voruciclib, a clinical stage oral and selective cyclin-dependent kinase (CDK) inhibitor.

Under this license agreement, MEI Pharma receives exclusive rights worldwide to manufacture and commercialize voruciclib. In return, Presage Bioscience will receive near-term payments of around $2.9 million and additional payments of up to $181 million upon achievement of certain regulatory and commercial milestones. Presage Bioscience also receives mid-single-digit tiered royalties on the overall net sales of any product that is successfully developed.

Daniel P. Gold, President and Chief Executive Officer of MEI said, “We are very excited by this opportunity to add voruciclib to our growing pipeline of clinical-stage oncology drug candidates. Voruciclib is a selective CDK inhibitor, a class of drugs that have recently demonstrated significant clinical and commercial value, and is differentiated by its potent inhibition of CDK9. This is an attractive asset that comes with an established clinical safety profile, along with compelling pre-clinical data showing suppression of MCL1, a known mechanism of resistance to BCL2 inhibitors, and synergy with the FDA-approved BCL2 inhibitor venetoclax. We believe this provides a clear and efficient clinical development path forward in combination with venetoclax. We appreciate that Presage put their trust in us to execute this plan and we are eager to get started.”

cyclin-dependent kinase (CDK) inhibitor, voruciclib (formerly known as P1446A) has been tested in around 70 patients in multiple Phase 1 studies. The phase 1 studies are associated with manageable side effects that are consistent with other drugs in its class. The common side effects include nausea, vomiting and diarrhoea.

During the preclinical studies, voruciclib alone can induce cell death in samples derived from chronic lymphocytic leukaemia (CLL). Voruciclib also shows dose dependent suppression of MCL1 at concentrations achievable with doses that appeared to be generally well tolerated in the Phase 1 studies.  According to the research studies, MCL1 has an established resistance mechanism to the B-cell lymphoma 2 (BCL2) inhibitor venetoclax.

David Johnson, Chairman of Presage said, “Voruciclib is a promising drug candidate with the potential to overcome mechanisms of drug resistance and significantly improve patient outcomes. The management team at MEI Pharma has a proven track record in oncology therapeutic development and we believe they have the clinical, regulatory and CMC expertise to maximize the value of this asset. This transaction also enables us to focus our attention on identifying and advancing additional drug candidates and combinations using our powerful CIVO™ intratumoral micro dosing platform.”

U.S. Food and Drug Administration has approved two CDK inhibitors, palbociclib and ribociclib. Palbociclib is marketed as Ibrance whereas ribociclib is marketed as Kisqali. Both the oral, selective CDK4/6 inhibitors are approved for the treatment of hormone receptor -positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in combination with hormonal therapy.

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