Ensem’s CDK2 inhibitor blocks the activity of cyclin-dependent kinase 2, thereby targeting uncontrolled cell growth. Credit: andresr via Getty Images.

BeiGene has acquired an exclusive global licence to an oral cyclin-dependent kinase-2 (CDK2) inhibitor to treat breast cancer from Boston-based Ensem Therapeutics.  

As part of the agreement, Ensem will receive an undisclosed upfront payment and will be eligible for additional payments upon the achievement of defined milestones, in a total of up to $1.33bn, in addition to tiered royalties. According to the company, the new candidate is investigational new drug (IND) application-ready. 

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CDK inhibitors block the activity of CDKs, which play a crucial role in breast cancer by promoting abnormal cell cycle progression, contributing to uncontrolled cell growth and tumour formation. 

Most CDK inhibitors target both CDK4 and CDK6. There are three CDK4/6 inhibitors that are US Food and Drug Administration (FDA)-approved to treat certain types of hormone receptor-positive (HR+) HER2-negative breast cancer: Pfizer’s Ibrance (palbociclib), Novartis’ Kisqali (ribociclib) and Eli Lilly’s Verzenio (abemaciclib).  

Over the years these drugs have been incorporated into the standard of care for this breast cancer subtype, and have become significant revenue drivers for the company. In 2022, Ibrance generated $5.1bn in sales, Kisqali $1.2bn, and Verzenio $1.3bn, as per the companies’ respective 2022 financial reports.  

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Still, some breast cancer patients don’t respond to CDK4/6 inhibitors and there are issues of toxicity and building resistance, which limit their effectiveness. Since the initial approvals of these CDK 4/6 inhibitors, the field has branched out to evaluate inhibitors that target other CDK pathways. For example, Pfizer’s tagtociclib is a CDK2 inhibitor currently in Phase II clinical trials for several cancer types, including lung cancer, fallopian tube cancer and triple-negative breast cancer (TNBC). 

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Ensem and BeiGene’s CDK2 candidate was developed leveraging Ensem’s Kinetic Ensemble platform, a computational and artificial intelligence (AI)-based drug discovery platform, used to develop small molecule precision medicines for oncology. The Boston-based biotech raised $67m in Series A financing to develop small molecule medicines for difficult-to-drug targets last year.  

In the announcement accompanying the partnership, Ensem CEO Shengfang Jin said: “We believe BeiGene is the right partner to advance our first IND-ready asset due to their wealth of expertise in bringing innovative cancer therapies to patients globally. This partnership validates the capabilities of Ensem’s drug discovery and development team and the ability to rapidly advance potential best-in-class or first-in-class molecules utilising our Kinetic Ensemble platform.”