Chinese biotechnology company BeiGene has agreed to acquire an exclusive global licence to an oral cyclin-dependent kinase 2 (CDK2) inhibitor from the US-based Ensem Therapeutics.

Ensem’s CDK2 inhibitor, dubbed ETX-197, is an investigational new drug (IND) application-ready drug candidate, intended for the treatment of breast cancer.

Under the terms of the agreement, the US drugmaker will receive an upfront payment and will be eligible for additional payments totalling up to $1.33bn, in addition to tiered royalties.

The additional payments are contingent upon the achievement of certain development, regulatory, and commercial milestones.

BeiGene R&D global head Lai Wang said: “We are committed to developing novel molecules with the potential to transform the therapeutic landscape for cancer patients, and this partnership fits well with our strategic focus on breast cancer as an area with tremendous unmet need for innovative treatment options.

“This CDK2 inhibitor from Ensem complements our internally discovered Phase 1 CDK4 inhibitor, which has the potential to improve upon current CDK4/6 inhibitors in some breast cancer patients and strengthens our early development pipeline in breast cancer and other solid tumours.”

Ensem is a drug discovery and development company that leverages its Kinetic Ensemble platform to develop innovative small molecule precision medicines for oncology.

It integrates computational and AI-based deep learning methodologies with advanced experimental techniques to advance structure-based drug design.

CDK2, an enzyme that is encoded by the CDK2 gene in humans, plays an important role in cell cycle regulation and is often found hyper-activated in several cancer types.

According to Ensem, CDK2 is a critical component of the abnormal growth of cancer cells and a preclinically validated oncology target, with no CDK2-specific drug available in the market.

Ensem said that its ETX-197 can treat patients with tumours that have cyclin E amplification and those who acquired resistance to standard of care due to dysregulation of CDK2 activity.

Ensem president and 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 utilizing our Kinetic Ensemble platform.

“We look forward to progressing our additional pipeline programs to help patients in need and supporting BeiGene’s important work to take this therapy into clinical trials.”