November 13, 2007

Preclinical Data Published in Cancer Science Show AVEO’s Novel Oral EGFR Inhibitor AV-412 Effective in Drug-Resistant Cancers

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AV-412 Has Potential to Address Drug Resistance in Non-Small Cell Lung and Breast Cancer

CAMBRIDGE, MA, November 13, 2007 – AVEO Pharmaceuticals, Inc., today announced encouraging preclinical data that show the potential of AV-412, a novel next generation oral tyrosine kinase inhibitor, as a therapeutic agent for the treatment of drug-resistant cancers expressing EGFR and ErbB2 mutations, such as non-small cell lung cancer and breast cancer.   AVEO acquired worldwide rights outside of Asia to AV-412 from Mitsubishi Tanabe Pharma Corporation in 2006.

According to the data reported by Mitsubishi Tanabe Pharma and published in the current issue of Cancer Science — the official journal of the Japanese Cancer Association — AV-412 produced potent anti-tumor effects in several variants of EGFR kinase, including L858R and T790M double mutants, which are known to be resistant to erlotinib (Tarceva®) and gefitinib (Iressa®).  In addition, AV-412 also demonstrated significant anti-tumor effects on the ErbB2-overexpressing breast cancer KPL-4 cell line, which is resistant to gefitinib.

The currently approved molecularly targeted drugs erlotinib and gefitinib inhibit EGFR kinase activity and are important therapies for patients with non-small cell lung cancer; however, resistance to EGFR kinase inhibitors uniformly develops over time often due to the acquisition of resistance mutations within the EGFR gene. Notably, erlotinib and gefitinib have no effect on the EGFR L858R/T790M double mutant, which is estimated to account for approximately 50 percent of all drug resistance in EGFR mutant non-small cell lung cancer – representing a key unmet medical need.

“This important preclinical data showing AV-412’s potent inhibition of the EGFR L858R and T790M mutations, which are resistant to the currently available targeted therapies, provide additional insight into the development opportunities and clinical potential of this novel, potent kinase inhibitor,” said Tuan Ha-Ngoc, President and CEO of AVEO Pharmaceuticals. “We look forward to advancing the clinical program for AV-412 and to obtaining the data from our ongoing Phase 1 clinical trials of AV-412 next year.”

About AV-412

AV-412 is a next generation oral tyrosine kinase inhibitor of the EGFR and ErbB2 mutations that could potentially treat patients with drug-resistant cancers. In preclinical studies, AV-412 has shown excellent activity in various tumor models including non-small cell lung cancer, has a toxicity profile similar to other molecules in its class and has shown preclinical activity against tumor cells that are resistant to the current tyrosine kinase inhibitors. The targets of AV-412 have been implicated in many significant human cancers including non-small cell lung cancer, metastatic breast cancer, pancreatic cancer, head and neck cancer and hormone refractory prostate cancer. AVEO’s proprietary Human Response Platform offers an opportunity to exploit AV-412’s unique characteristics and will provide further insight into potential clinical settings, tumor subtypes and responsive patient populations.  The drug is currently being evaluated in ongoing Phase 1 clinical trials with data expected in 2008.

About AVEO

AVEO is a private biopharmaceutical company focused on the discovery and development of novel, targeted cancer therapeutics.  AVEO’s proprietary, integrated cancer biology platform enables the company to pursue highly efficient drug development strategies in oncology that increase the probability of clinical success and provides a discovery engine for high-value targets. This approach has resulted in a balanced pipeline of novel cancer therapies focused on well-validated targets (VEGFR, EGFR) and promising novel targets (HGF), as well as collaborations with Merck, OSI Pharmaceuticals and Schering-Plough.  Through a combination of internal drug discovery and selective in-licensing of targeted therapeutics, AVEO is building a diversified product pipeline and moving toward its vision of becoming a fully integrated biopharmaceutical company. For more information, please visit the company’s website at

About Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma Corporation, one of the leading pharmaceutical companies in Japan, specializes in developing and marketing globally competitive pharmaceutical products in the fields of cardiovascular and metabolic diseases, brain and nerve diseases, and renal and urinary system diseases.  The Company, established through the merger of Tanabe Seiyaku Co., Ltd. and Mitsubishi Pharma Corporation in October 2007, drives for the expansion of its operations and the reinforcement of its future growth with the aim of becoming a global research-driven pharmaceutical company and taking on the challenge of new business opportunities.  Mitsubishi Tanabe Pharma is committed to protect the health of people around the world and contribute to comfortable lifestyles through creating pharmaceuticals.  For more information, please visit the web site at