Type of information: Milestone
Company: Aveo Oncology (USA - MA) CANbridge Life Sciences (China)
Therapeutic area: Cancer - Oncology
Type agreement: collaboration, licensing
Action mechanism: monoclonal antibody. AV-203 is a clinical-stage ErbB3 (HER3) inhibitory antibody candidate designed to inhibit both ligand-dependent and ligand-independent ErbB3 signaling. ErbB3 is a receptor that is typically expressed in many human cancers, and AV-203 has demonstrated preclinical activity in a number of different tumor models including breast, head and neck, lung, ovarian and pancreatic cancers. AVEO has successfully completed a Phase 1 safety study showing no dose limiting toxicities at maximum dose of 20mg/kg and CLIA (Clinical Laboratory Improvements Amendment) validation has been completed for a biomarker for potential patient selection.
Disease: esophageal squamous cell cancer
- • On March 21, 2016, Aveo Oncology and CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced an exclusive collaboration and license agreement in which Aveo has granted CANbridge Life Sciences worldwide rights, excluding the United States, Canada, and Mexico, to AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate.
- CANbridge plans to develop AV-203 first in esophageal squamous cell cancer (ESCC). To date, Aveo has completed a Phase 1, open-label, dose-escalation study of AV-203 in patients with advanced solid tumors. In this study, AV-203 was found to be generally safe and well-tolerated, with an early signal of activity consistent with preclinical data showing the potential for heregulin, the only known ligand for ErbB3, to serve as a biomarker predictive of AV-203 anti-tumor activity.
- Under the terms of the agreement, CANbridge Life Sciences is obligated to pay AVEO an upfront payment of $1 million plus up to $133 million in potential reimbursement and milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives. AVEO is also eligible for a tiered royalty, with a percentage range in the low double digits, on net sales of AV-203 in the agreement’s territories.
- CANbridge Life Sciences will be responsible for costs associated with the execution of a development plan that includes additional manufacturing requirements as well as pre-clinical and clinical studies necessary to demonstrate proof-of-concept for AV-203 as a treatment for squamous cell esophagus cancer, including a Phase IIa proof-of-concept study meeting mutually agreed upon criteria. Following completion of the proof-of-concept studies, AVEO and CANbridge will negotiate a possible agreement under which they may co-develop AV-203, with each party bearing a percentage of the cost of global development activities based on respective geographic rights. If the parties fail to reach such an agreement, CANbridge may continue the development of AV-203 on its own in markets outside of the United States, Canada and Mexico.
- • On April 3, 2017, Aveo Oncology announced receipt of a $500,000 milestone payment from CANbridge Life Sciences, related to a technology transfer milestone for AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate. AV-203 has demonstrated preclinical activity in a number of different tumor models including breast, head and neck, lung, ovarian and pancreatic cancers. CANbridge is planning clinical development of AV-203 in squamous cell esophageal cancer as its initial indication.