- AVZO-021 demonstrated a potential best-in-class preclinical potency, selectivity and pharmacokinetic profile

- AVZO-021 is currently in an ongoing U.S.-based Phase 1 clinical study in advanced solid tumors

- Avenzo also obtains an exclusive option to an additional preclinical program planned for Investigational New Drug (IND) submission in early 2025

Avenzo Therapeutics, Inc. (Avenzo), a clinical-stage biotechnology company developing next generation oncology therapeutics, today announced that it has entered into an exclusive licensing agreement with Allorion Therapeutics Inc. (Allorion) to develop and commercialize AVZO-021 (formerly ARTS-021), a potentially best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor globally (excluding Greater China). As part of the agreement, Avenzo also receives an exclusive option for an additional preclinical program planned for IND submission in early 2025.

CDK2 has emerged as a promising target given its role as a resistance mechanism to approved CDK4/6 therapies in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer, and given its role as an oncogene in many cyclin E1 (CCNE1) amplified cancers. Avenzo will leverage its internal drug development expertise to advance AVZO-021, which is currently being studied in a Phase 1 clinical trial across multiple sites in the U.S. for the treatment of HR+/HER2- metastatic breast cancer and other advanced solid tumors.

“With this agreement, we have laid the foundation for our potentially best-in-class oncology pipeline,” said Athena Countouriotis, M.D., co-founder, president and CEO of Avenzo. “Patients with HR+/HER2- metastatic breast cancer continue to have limited therapeutic options, and we believe AVZO-021 may provide patients with a new treatment option both as a single agent and in multiple combinations. We are excited to advance the ongoing Phase 1 clinical study (NCT05867251), and to partner with the Allorion team to advance the program globally.”

Under the terms of the license agreement, Allorion will receive an upfront payment of $40 million and be eligible to receive additional payments based on achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Avenzo. Potential payments for both programs may total more than $1 billion.

“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. We are delighted to partner with Avenzo to drive innovation and transform the treatment landscape for cancer patients.”

“AVZO-021 is a highly potent and selective CDK2 inhibitor for the treatment of HR+/HER2- breast cancer and CCNE1-amplified cancers,” said 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. “I look forward to working with Avenzo as they continue to develop this therapy that has the potential to provide a new treatment option to patients fighting cancer.”

In preclinical studies, AVZO-021 exhibited nanomolar potency against CDK2 while sparing other CDKs with high selectivity over CDK1, a key driver of toxicity. In addition, AVZO-021 demonstrated efficacy in in vivo xenograft models, both as a single agent and in combination with CDK4/6 inhibitors. Allorion disclosed select data in poster presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October 2023.

About Avenzo Therapeutics, Inc.

Avenzo Therapeutics is a clinical-stage biotechnology company focused on developing the next generation of oncology therapies for patients. The company’s lead drug candidate, AVZO-021, is a novel, highly potent and selective inhibitor of CDK2, a key enzyme involved in cell cycle regulation. AVZO-021 is being studied in a Phase 1 study in the U.S. for the treatment of advanced solid tumors. Avenzo is headquartered in San Diego, California. For more information, visit us at www.avenzotx.com or on LinkedIn.

About Allorion Therapeutics Inc.

Allorion Therapeutics is a clinical-stage biotechnology company that focuses on creating new small molecule drugs for treating cancer and autoimmune diseases. The company has a team of experienced drug discovery and development professionals who identify new drugs with unique mechanisms of actions and develop innovative data and screening platforms for long-term success. Allorion Therapeutics aims to advance new drugs with high potential and clinical relevance.

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