June 16, 2010
AVEO Pharmaceuticals Granted Patents for Diagnostic Tests to Identify Patient Populations Likely to Respond to Tivozanib Treatment
AVEO’s Human Response Platform(TM) Enables Discovery of Biomarkers to Predict Patient Response
CAMBRIDGE, Mass., Jun 16, 2010 (BUSINESS WIRE) –AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced the issuance of U.S. Patent Nos. 7,615,353, which issued in November 2009, and 7,736,861, which issued yesterday. These patents cover two different diagnostic tests for identifying human patients likely to respond to treatment with tivozanib, AVEO’s highly potent and selective inhibitor of VEGF receptors 1, 2 and 3, which is currently being evaluated in a global Phase 3 clinical trial, TIVO-1, in patients with renal cell cancer (RCC).
The first of these patents covers a diagnostic test based on a 42-gene expression signature in tumor samples. The second patent covers a diagnostic test based on measurement of the abundance of a single protein, known as CD68, in tumor samples. Both tests can be performed using fresh or preserved tumor biopsy material. AVEO’s successful use of its genetically engineered mouse models to discover these human-relevant biomarkers demonstrates the potential of AVEO’s preclinical tumor models in human response prediction.
“We believe these tests reflect different aspects of the same underlying tumor biology and have potential for development as companion diagnostics in a broad range of tumor types. Ongoing research involving these tests will help AVEO make informed decisions as we explore the use of these biomarkers in our clinical programs,” commented Tuan Ha-Ngoc, president and chief executive officer of AVEO Pharmaceuticals. “Predictive biomarkers and companion diagnostics are likely to play an important role in the future success of targeted oncology therapeutics. We believe that, with our proprietary bioinformatics tools and Human Response Platform(TM) technology, AVEO is at the forefront of predictive biomarker discovery.”
Tivozanib, an investigational new drug, is a highly potent and selective inhibitor of VEGF receptors 1, 2 and 3, exhibiting picomolar inhibitory activity against all three receptors. Due to its potency and specificity, AVEO believes tivozanib may enable optimal inhibition of the VEGF pathway, while minimizing side effects associated with off-target activity. Such a profile may enable tivozanib to be more readily combined with standard chemotherapy as well as other targeted therapies, potentially increasing the breadth of its clinical utility.
Following the successful completion of Phase 1 and Phase 2 clinical trials, AVEO has launched a comprehensive clinical development program in support of tivozanib. In addition to the TIVO-1 trial, AVEO is currently conducting multiple Phase 1b clinical trials of tivozanib in various combinations and dosing regimens in RCC and additional solid tumor indications, including breast cancer and colorectal cancer.
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 HGF, ErbB3, RON, 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 the diagnostic tests’ potential for development as companion diagnostics in a broad range of tumor types,the potential of AVEO’s preclinical tumor models in human response prediction, the important role predictive biomarkers and companion diagnostics are likely to play on the future success of targeted oncology therapeutics, tivozanib’s ability to enable optimal inhibition of the VEGF pathway while minimizing side effects, tivozanib’s potential to be more readily combined with standard chemotherapy as well other targeted therapies, our Human Response 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 and our other product candidates; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies, including our diagnostic tests; 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.
SOURCE: AVEO Pharmaceuticals, Inc.
AVEO Pharmaceuticals, Inc.
David Johnston, Chief Financial Officer
Caton Lovett, 910-232-7166