June 30, 2010

AVEO Pharmaceuticals’ Human Response Platform(TM) and Proprietary Mouse Models Featured in Nature Reviews Cancer

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CAMBRIDGE, Mass., Jun 30, 2010 (BUSINESS WIRE) — AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced the publication of a cover article in the current issue of Nature Reviews Cancer summarizing the recent development of improved preclinical modeling approaches to cancer drug development. Citing the accelerated discovery of new cancer genes emerging from large-scale cancer genomics as well as the extensive number of new compounds emerging from the drug discovery pipeline, the authors note the need for improved models to provide crucial insights. The review highlights a growing collection of innovative non-germline genetically engineered mouse (nGEMM) models, an approach core to AVEO’s proprietary cancer biology platform. The authors, who include Joerg Heyer, Ph.D., director, genetic models, AVEO Pharmaceuticals, believe these next generation models will pave the way for much needed efficient and accurate preclinical therapeutic testing.

“In oncology, we believe a critical need remains for preclinical models that more accurately reflect human cancers,” stated Murray Robinson, Ph.D., senior vice president, translational medicine, AVEO Pharmaceuticals. “Through our proprietary Human Response Platform, AVEO has developed a library of mouse models in an effort to better identify responsive patient populations and inform the clinical development strategy for our pipeline of cancer therapeutics.”

The article, “Non-germline genetically engineered mouse models for translational cancer research,” co-authored by Dr. Heyer; Lawrence N. Kwong, Ph.D., Belfer Institute for Applied Cancer Science and department of medical oncology, Dana-Farber Cancer Institute; Scott W. Lowe, Ph.D., deputy director, Cancer Center at Cold Spring Harbor Laboratory and investigator, Howard Hughes Medical Institute; and Lynda Chin, M.D., co-founder of AVEO, professor of dermatology, Harvard Medical School, scientific director, Belfer Institute for Applied Cancer Science, Dana-Farber Cancer Institute and associate member, Broad Institute, Massachusetts Institute of Technology and Harvard; was published in the July 2010 issue, which is available online at http://www.nature.com/nrc/index.html.

The authors emphasize their view that the nGEMM models highlighted in the Nature Reviews Cancer articleoffer flexibility, speed, and uniformity at reduced costs, thus paving the way for much needed throughput and practical models for preclinical therapeutic testing. In addition, the authors concluded that certain models discussed in the article have already demonstrated broad applicability for translational research and biomarker discovery, an area of major focus across drug discovery and development in oncology. With respect to human relevance and predictability, these models focus on three key elements of tumors: genetics, context and variation. Genetics refers to tumors being driven by signature genetic events also found clinically in patients. Context requires that tumors occur de novo in a micro-environment that features appropriate interactions between developing tumor and its cellular and tissue environment. Variation refers to tumors spontaneously-acquiring genomic alterations and mutations representative of the heterogeneity seen in patients.

“AVEO believes that it has addressed these key elements in the creation of each of its three platforms: chimeric models, human-in-mouse models and population based models,” commented Dr. Heyer. “Chimeric models develop tumors in the context of normal stroma with reduced timelines and mouse housing cost. Human donor tissue models, or human-in-mouse, allow the de novo development of primary human tumors in mouse stroma by means of manipulating primary human tissue stem cells. To capture the variation inherent among tumors, each of these complex models is further developed into a population based model by collecting and characterizing large numbers of tumors from each model. Like human tumors, each tumor of each model harbors varied spontaneously acquired mutations that result in varied sensitivity to anti-cancer agents.”

AVEO believes that application of chimeric, human-in-mouse and population based models to the drug discovery process, including AVEO’s Human Response Platform, allows for faster and more efficient preclinical development as compared to traditional GEMMs.

About AVEO’s Human Response Platform(TM)

For decades, the standard preclinical model for testing the efficacy of novel oncology drug candidates has been the human tumor xenograft. However, well-known challenges with these models include the artificial nature of the implanted tumor cells, which have adapted for growth in culture as opposed to an in vivo environment that would most closely mimic tumor activity in humans. Despite the low success rate of oncology products in clinical development – in part due to the high rate of false positives associated with this method of testing – xenografts are used broadly throughout the industry.

AVEO’s Human Response Platform is based on the company’s proprietary, genetically-defined mouse models of human cancer, in which each model is engineered to contain signature genetic mutations that are present in human disease. Beyond these cancer-initiating engineered mutations, the resultant tumors acquire common and distinct spontaneous mutations during tumor progression. These mutations provide additional natural genetic variation more akin to the range of genetic heterogeneity encountered across different primary human tumors. AVEO is using its capabilities to develop its own pipeline of oncology therapeutics and has engaged in partnerships with leading biotechnology companies to seek to leverage its platform.

About AVEO

AVEO Pharmaceuticals (NASDAQ: AVEO) integrates a proprietary cancer biology platform with drug development and commercial expertise in its efforts to discover and develop targeted cancer therapeutics. The company’s lead product, tivozanib, is an oral, triple VEGF receptor inhibitor with potential for a best-in-class profile. Tivozanib is currently being investigated in a global, randomized Phase 3 clinical trial called TIVO-1 comparing tivozanib to sorafenib in advanced kidney cancer, as well as additional clinical studies in other solid tumor types. AVEO’s proprietary, integrated cancer biology platform offers the company a unique advantage in oncology drug development that both increases the probability of clinical success and provides a discovery engine for high-value targets. This approach has resulted in a promising pipeline of monoclonal antibodies against novel targets including HGFErbB3RON, Notch and FGFR. For more information, please visit the company’s website at www.aveopharma.com.

Any statements in this press release about our future expectations, plans and prospects, including statements about nGEMM models paving the way for much needed efficient and accurate preclinical therapeutic testing and development and offering flexibility, speed and uniformity at reduced costs, the company’s cancer biology platform increasing the probability of clinical success and providing a discovery engine for high-value targets, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will,” 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 tivozanib, AV-299and 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 and 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-Q 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.

AVEO has included in this press release links to its website and certain third party websites, including http://www.nature.com/nrc/index.html. AVEO cautions you that the information on such websites is not incorporated by reference into this press release and should not be considered to be a part of this press release.

SOURCE: AVEO Pharmaceuticals, Inc.

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