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AVEO's AV-203 in Phase I

Zacks Equity Research

AVEO Pharmaceuticals, Inc. (AVEO) recently initiated a phase I study with its oncology candidate, AV-203. AV-203 is an ERBB3 inhibitory antibody and AVEO’s third clinical stage candidate.

The multi-center, dose escalation study will evaluate the candidate’s safety and preliminary tolerability among other endpoints.  The use of predictive biomarkers will also be explored.

AVEO and Biogen Idec International GmbH, a subsidiary of Biogen Idec Inc. (BIIB), have a strategic alliance to develop and commercialize ERBB3 antibodies for the treatment of cancer. AV-203 is a monoclonal antibody which targets the receptor ERBB3. ERBB3 is a fresh and promising strategy for potentially treating cancer. The pipeline candidate was developed through AVEO’s Human Response Platform.

Other pipeline candidates at AVEO include tivozanib (renal cell cancer) and ficlatuzumab (non-small cell lung cancer). While ficlatuzumab is in phase II studies, AVEO is preparing to file its new drug application (:NDA) for tivozanib in the third quarter of 2012. Other indications for which tivozanib is being evaluated include colorectal cancer and breast cancer, which are currently in phase II and I development, respectively.

Notably, in early 2012, TIVO-1, a phase III clinical study that evaluated the efficacy and safety of tivozanib, successfully met the primary endpoint.

Our Take

We are pleased with the pipeline progress at AVEO. We expect investor focus to remain on the filing of an NDA for tivozanib. Approval of tivozanib will be a major milestone for the company. We currently have a Neutral recommendation on AVEO in the long run. The company carries a Zacks #3 Rank (Hold rating) in the short run.

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