Allorion’s CDK2 inhibitor at center of potential $1B licensing deal with Avenzo

Amid a flurry of dealmaking activity to start 2024, Allorion Therapeutics Inc., a 2020 startup based in Natick, Mass., and Guangzhou, China, has been extra busy. Two days after disclosing a potential $540 million deal with Astrazeneca plc, Allorion inked a licensing agreement with Avenzo Therapeutics Inc. that could total more than $1 billion.

The latest move grants San Diego-based Avenzo exclusive worldwide rights, with the exception of greater China, to ARTS-021 (now AVZO-021), a CDK2 inhibitor in phase I testing for HR-positive/HER2-negative metastatic breast cancer and other advanced solid tumors. As part of the deal, Avenzo also gets an exclusive option for an additional preclinical program set for a planned IND submission in early 2025.

Under the terms, Allorion receives an up-front payment of $40 million. Additional payments are tied to development, regulatory and commercialization milestones, plus tiered royalties on net sales. Financial terms for each program were not detailed, but Allorion said potential payments for both AVZO-021 and the preclinical program could exceed $1 billion.

CDK2 emerged as a potential cancer target 30 years ago, but development initially was hampered by off-target effects. Recently, however, it has gained traction, with recent efforts by Genentech Inc., Iambic Therapeutics Inc., Prelude Therapeutics Inc, Incyclix Bio LLC, Blueprint Medicines Corp. and Pfizer Inc. In June, Bayer AG invested in the space by signing an exclusive license deal with Cedilla Therapeutics for its CDK2 complex inhibitors. And two months ago, startup Ensem Therapeutics Inc. landed a deal potentially worth $1.33 billion with Beigene Ltd. for its IND-ready oral CDK2 inhibitor.

Preclinical data presented by Allorion at the AACR-NCI-EORTC International Conference in October 2023 highlighted the drug’s potential across a range of solid tumors, including small-cell lung cancer, ovarian cancer and gastric cancer. It also demonstrated efficacy in in vivo xenograft models, both as a single agent and in combination with CDK4/6 inhibitors.

That same month, Allorion dosed the first patient in a phase I/II trial in advanced or metastatic solid tumors.

"We developed AVZO-021 as a potential best-in-class CDK2-selective inhibitor to address an area of unmet medical need," said Peter Ding, co-founder and CEO of Allorion. "The Avenzo team has a proven track record and deep expertise in developing and advancing next-generation oncology therapies."