AVEO Pharmaceuticals, Inc. (AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, announced the issuance of US Patent Nos. 7,615,353, which issued in November 2009, and 7,736,861, which issued on June 15. 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 tumour samples. The second patent covers a diagnostic test based on measurement of the abundance of a single protein, known as CD68, in tumour samples. Both tests can be performed using fresh or preserved tumour 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 tumour models in human response prediction.

"We believe these tests reflect different aspects of the same underlying tumour biology and have potential for development as companion diagnostics in a broad range of tumour 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 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 tumour indications, including breast cancer and colorectal cancer.