AVEO Oncology (NASDAQ: AVEO) today announced that it has regained worldwide rights to AV-203, a clinical-stage ErbB3 (HER3) inhibitory antibody candidate, from Biogen Idec.
“We are pleased to regain rights for AV-203 as we believe in the potential of this innovative therapy and are looking forward to maximizing its value,” said Michael Bailey, chief business officer, AVEO Oncology. “As stated in our recently outlined strategy, this amended agreement enables us to seek a partner with established oncology capabilities that can accelerate and financially support the clinical development of AV-203.”
In May 2013, AVEO successfully completed a Phase 1 safety study with AV-203 showing no dose limiting toxicities across the entire dose range up to and including the maximum administered dose of 20mg/kg. Results from the Phase 1 study are expected be presented at a scientific meeting in 2014. CLIA (Clinical Laboratory Improvements Amendment) validation has been completed for a biomarker for potential patient selection.
In March 2009, AVEO entered into an exclusive option and license agreement with Biogen Idec Inc. regarding the development and commercialization of AVEO’s discovery-stage ErbB3-targeted antibodies for the potential treatment and diagnosis of cancer and other diseases outside of North America. AVEO retained the exclusive right to commercialize ErbB3 antibody products in North America. Under the terms of the amended agreement, Biogen waives its option to rights outside of North America to AV-203, thereby providing worldwide rights to AV-203 to AVEO. In exchange, AVEO will have certain financial obligations to Biogen with respect to amounts AVEO receives from certain development and sales milestones and royalties on net sales for AV-203.
AV-203 is a potent and selective 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.