AVEO Pharmaceuticals, Inc. : AVEO Initiates Phase 1 Study of AV-203, an ERBB3 Inhibitory Antibody, in Advanced Solid Tumors

AV-203 is the Third AVEO Molecule to Enter Clinic

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."

About AV-203

AV-203 is an ERBB3 inhibitory antibody developed through AVEO's Human Response Platform™, and AVEO's third clinical-stage product candidate. AV-203 is currently being investigated in a Phase 1 clinical trial to evaluate safety and preliminary efficacy, as well as exploratory biomarkers, in patients with advanced solid tumors.

AV-203 selectively targets the receptor ERBB3, a new and promising strategy for treating cancer, both for direct anti-tumor activity and for prevention of treatment resistance. ERBB3 belongs to a family of four proteins that also includes the EGFR (HER1) and HER2 receptors, and is a potent stimulator of cancer growth and survival. AV-203 has demonstrated preclinical activity in a range of solid tumor models including breast, head and neck, lung, ovarian and pancreatic cancers.

In March 2009, AVEO entered into an exclusive option and license agreement with Biogen Idec International GmbH, a subsidiary of Biogen Idec, regarding the development and commercialization outside of North America of AVEO's discovery-stage ERBB3-targeted antibodies for the potential treatment and diagnosis of cancer and other diseases. Under terms of the agreement, AVEO is responsible for developing ERBB3 antibodies through completion of the proof-of-concept clinical trial designed to allow dose selection and support generation of efficacy data that would allow movement to a Phase 3 clinical trial. AVEO retains the exclusive right to commercialize ERBB3 antibody products in North America.

About AVEO

AVEO Oncology (NASDAQ: AVEO) is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients' lives. AVEO's proprietary Human Response Platform^TM provides the company unique insights into cancer biology and is being leveraged in the discovery and clinical development of its cancer therapeutics. For more information, please visit the company's website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements in this press release about AVEO's future expectations, plans and prospects, including statements about ERBB3 representing a promising target for treating cancer; ERBB3's role in tumor formation and proliferation and development of resistance to EGFR and HER2 inhibitors; AV-203's potential as an anti-cancer therapy; possible insights which may be derived from such clinical trial; our Human Response Platform increasing the probability of a predictive biomarker and/or clinical success; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for AV-203, tivozanib and our other product candidates; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses or our inability to raise substantial additional funds to achieve our goals; general economic and industry conditions; and other factors discussed in the "Risk Factors" section of our most recent Form 10-K filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Investor Contact:
AVEO Oncology
Monique Allaire, 617-299-5810
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Media Contacts:
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Rob Kloppenburg, 617-930-5595
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