Pharma Focus Asia

Avenzo Therapeutics Licenses ARTS-021, a Clinical Stage CDK2 Inhibitor from Allorion

Friday, January 05, 2024

Avenzo Therapeutics, Inc. (Avenzo) recently announced an exclusive licensing agreement with Allorion Therapeutics Inc. (Allorion) for the global development and commercialization of AVZO-021, a potential best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor, excluding Greater China. This collaboration also grants Avenzo an exclusive option for an additional preclinical program set for IND submission in early 2025.

CDK2 has emerged as a promising target, particularly in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer, where it acts as a resistance mechanism to approved CDK4/6 therapies, as well as in cyclin E1 (CCNE1) amplified cancers. Avenzo aims to utilize its internal drug development expertise to advance AVZO-021, currently undergoing Phase 1 clinical trials in the U.S. for HR+/HER2- metastatic breast cancer and other advanced solid tumors.

Athena Countouriotis, M.D., co-founder, president, and CEO of Avenzo, expressed optimism about the potential of AVZO-021, stating it could offer new treatment options for patients. The agreement includes an exclusive option for an additional preclinical program planned for submission in 2025.

Under the licensing terms, Allorion will receive an upfront payment of $40 million and may earn additional payments based on specified development, regulatory, and commercial milestones. Furthermore, tiered royalties on net sales by Avenzo could result in total potential payments exceeding $1 billion for both programs.

Peter Ding, co-founder and CEO of Allorion, highlighted AVZO-021's development to address unmet medical needs and expressed enthusiasm for the collaboration with Avenzo. The agreement aims to drive innovation and transform the cancer treatment landscape.

AVZO-021, a highly selective CDK2 inhibitor, has shown promising results in preclinical studies. It demonstrated nanomolar potency against CDK2 while sparing other CDKs, especially CDK1, a key contributor to toxicity. Efficacy was observed in in vivo xenograft models, both as a standalone treatment and in combination with CDK4/6 inhibitors. Select data from preclinical studies were presented by Allorion at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October 2023.

Afshin Dowlati, M.D., Professor of Medicine and Oncology at University Hospitals Seidman Cancer Center and Case Western Reserve, and Director of the Early Phase Therapeutics Program, expressed anticipation in working with Avenzo as they progress in developing AVZO-021, a potential new treatment option for cancer patients.



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