AVEO commences AV-203 Phase 1 study in advanced solid tumors

AVEO Oncology (Nasdaq: AVEO) today announced the initiation of a Phase 1 study examining the safety and preliminary efficacy of AV-203 along with exploratory biomarkers in patients with advanced solid tumors. AV-203 is a monoclonal antibody that selectively targets the receptor ERBB3, a new and promising strategy for treating cancer. AV-203 was developed through AVEO's Human Response Platform™, which evaluates drugs that can block the function of cancer-causing target genes and identifies biomarkers that are indicators of drug response or resistance in patients. This advancement marks the third AVEO product candidate to enter clinical development.    

"We believe ERBB3 represents an exciting new oncology target," said George Blumenschein, Jr., M.D., associate professor of medicine thoracic/head and neck medical oncology at the University of Texas, M.D. Anderson Cancer Center, and lead investigator of the AV-203 Phase 1 study. "Research has indicated ERBB3 acts as a central node of oncogenic signaling. It may play a critical role not only in tumor formation and proliferation across a broad range of cancer types, but also in the development of resistance to currently used EGFR and HER2 inhibitors. AV-203 has demonstrated potent inhibition of activated ERBB3 in a variety of human tumor models with different genetic backgrounds. I look forward to evaluating the utility of AV-203 as a potential new therapeutic option for patients living with cancer."

The AV-203 Phase 1 trial, a multi-center, dose-escalation study, will evaluate the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of AV-203 in subjects with metastatic or advanced solid tumors. Secondary endpoints in the study include characterizing the pharmacokinetic (PK) profile of AV-203 and anti-drug antibody levels, and evaluating the preliminary anti-tumor activity. A core component of the study will be the exploration of predictive biomarkers for AV-203 response identified using AVEO's Human Response Platform. Up to 30 patients are expected to enroll in the dose-escalation portion of the study, and up to 60 additional patients may be enrolled in the biomarker exploration component of the study. For further study details, please visit www.clinicaltrials.gov.

"With the initiation of this trial, we now have three targeted oncology therapeutic candidates in clinical development, all of which use distinct and novel mechanisms of action to fight cancer," said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. "The successful advancement of AV-203 into the clinic and the identification of a potential biomarker of AV-203 response provide further validation of the advantages of our proprietary Human Response Platform."