BeiGene Inks Potential $1.3B Deal with Ensem for Early-Stage CDK2 Inhibitor

M&A deal_iStock, AmnajKhetsamtip

Pictured: Businessmen shaking hands after closing a deal/iStock, AmnajKhetsamtip

BeiGene on Tuesday announced that it would acquire an exclusive global license to Ensem Therapeutics’ investigational and potentially best-in-class oral CDK2 inhibitor EXT-197, which is being developed for cancer.

The companies did not disclose the specific financial terms of the licensing agreement in the announcement but said that the deal could reach up to $1.33 billion if BeiGene meets all development, regulatory and commercial milestones. Waltham, Mass.-based biotech Ensem will also be eligible for tiered royalties on top of these payments.

Ensem CEO Shengfang Jin said in a statement that the partnership will leverage BeiGene’s expertise in bringing innovative cancer therapies to patients globally, while also validating his company’s Kinetic Ensemble platform and its ability to design and rapidly advance “potential best-in-class or first-in-class molecules.”

Ensem’s Kinetic Ensemble platform uses computational technologies to identify potentially undiscovered binding pockets and predict functional states of proteins, allowing for unique drug design strategies, according to the company.

EXT-197 is Ensem’s most mature candidate and is being developed as an oral inhibitor of the CDK2 protein, which is a central player in the regulation of the cell cycle and is known to be hyperactivated in cancers. CDK2 has been well-validated as an oncology target in preclinical studies but “there is no CDK2-specific drug on the market,” according to Ensem’s website.

With EXT-197 poised for an Investigational New Drug application, Jin said BeiGene “is the right partner to advance our first IND-ready asset.”

Lai Wang, global head of R&D at BeiGene, added that EXT-197 “complements” the company’s internal pipeline of CDK inhibitors, including a Phase I CDK4 blocker which “has the potential to improve upon current CDK4/6 inhibitors in some breast cancer patients.”

Tuesday’s partnership with Ensem “fits well with our strategic focus on breast cancer,” Wang said, noting that the deal also “strengthens our early development pipeline in breast cancer and other solid tumors.”

Their oncology pipeline includes the anti-PD-1 antibody tislelizumab, which Novartis returned to BeiGene in September 2023. The companies signed a collaboration deal in January 2021 to jointly develop tislelizumab in locally advanced or metastatic esophageal squamous cell carcinoma but ran into regulatory troubles in July 2022, when the FDA decided to delay its decision on tislelizumab until after it had inspected BeiGene’s facilities in China.

In September 2023, BeiGene announced that the FDA accepted the Biologics License Application for tislelizumab and is set to release its verdict in the second half of 2024.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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