On March 15, 2021 AVEO Oncology (Nasdaq: AVEO) reported that it will regain its rights to AV-203 outside of North America, its clinical-stage potent humanized IgG1 monoclonal antibody that targets ErbB3 (also known as HER3), following the voluntary termination of its collaboration and license agreement by CANbridge Life Sciences (Press release, AVEO, MAR 15, 2021, View Source [SID1234577596]). AVEO will regain rights to AV-203 in all territories outside of North America, and CANbridge has initiated the process to transfer all preclinical data and materials to AVEO. The transfer of rights and termination of the collaboration and license agreement will become effective on September 5, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AV-203 is an IgG1 antibody 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 multiple tumor models. To date, AVEO has completed a Phase 1, open-label, dose-escalation study of AV-203 in patients with advanced solid tumors (N=22). In this study, one patient had a dose limiting adverse event and the recommended phase 2 dose, or RP2D, is 20 mg/kg. One of two neuregulin positive (NRG1+) patients had a partial response. Neuregulin, the only known ligand for ErbB3, is a potential biomarker which may prove to be predictive of AV-203 anti-tumor activity.

"By reacquiring rights to AV-203 outside of North America, we add global rights to a third IgG1 antibody clinical candidate within our internally developed and diverse portfolio of oncology therapeutics," said Michael Bailey, president and chief executive officer of AVEO. "AV-203 has demonstrated early signs of activity in an NRG1+ patient that suggest it could have meaningful application in several areas of high unmet need in cancer. We look forward to advancing AV-203 in the clinic as part of our strategy for delivering long-term value from our pipeline programs. This strategy includes progress in our immunotherapy combination programs for FOTIVDA (tivozanib), potential initiation of a pivotal study of ficlatuzumab in head and neck squamous cell carcinoma, and the execution of our Phase 1 study of AV-380 for cancer cachexia."

Under their 2016 agreement, AVEO granted CANbridge Life Sciences worldwide rights, excluding the United States, Canada, and Mexico, to AV-203. CANbridge completed their manufacturing obligations under the agreement and AVEO received a $2 million development and regulatory milestone in August 2018 from CANbridge for regulatory approval from the National Medical Products Administration in China of an investigational new drug application for a clinical study of AV-203 in esophageal squamous cell cancer.