AVEO Pharmaceuticals Initiates First Clinical Trial of Novel HGF Antagonist in Patients with Advance Solid Tumors and Lymphomas

FOR IMMEDIATE RELEASE

Contacts:
Michael Christiano, AVEO Pharmaceuticals, Inc.
(617) 299-5925

Caton Lovett, Pure Communications
(910) 509-3975

AVEO Pharmaceuticals Initiates First Clinical Trial of Novel
HGF Antagonist in Patients with Advanced Solid Tumors and Lymphomas

-- SCH900105 (AV-299) Marks First of Several Monoclonal Antibodies from AVEO’s Discovery Platform;  Trial Triggers Milestone Under Agreement with Schering Plough --

CAMBRIDGE, Mass., September 23, 2008 – AVEO Pharmaceuticals, Inc., today announced that it has initiated a Phase 1 clinical trial to evaluate the safety, tolerability and recommended dose of SCH900105 (AV-299), its novel, highly potent antibody to hepatocyte growth factor (HGF), administered intravenously in patients with relapsed or refractory solid tumors or lymphoma.  SCH900105 (AV-299) is being developed in collaboration with Schering-Plough (NYSE: SGP). Under the terms of the agreement, human dosing with SCH900105 (AV-299) triggers a $3.0 million milestone payment from Schering Plough to AVEO.

“We are pleased to announce the initiation of clinical trials of SCH900105 (AV-299),” stated Tuan Ha-Ngoc, president and chief executive officer of AVEO.  “Working with Schering-Plough, our research teams have made rapid progress with this novel antibody.   The cMET/HGF pathway is one of the most promising in cancer research.  We believe that SCH900105 (AV-299) has the potential to be the best-in-class anti-HGF antibody. Our proprietary Human Response Platform (HRP™) promises to provide us with tools to move SCH900105 (AV-299) forward rapidly in clinical development.”

HGF is the soluble ligand for the c-Met receptor tyrosine kinase. Preclinical studies have provided strong evidence that signaling through the HGF/c-Met pathway mediates several cellular functions involved in tumor growth and metastasis, such as cell proliferation, angiogenesis, survival, migration, and invasion. Numerous studies have demonstrated a correlation between high HGF levels and poor prognosis in a wide variety of human malignancies including gastric, breast, and lung, suggesting that targeting HGF may provide a novel way of treating a broad range of cancers. 

“SCH900105 (AV-299) is the most advanced of our deep pipeline of internally discovered monoclonal antibodies, and we advanced this antibody from discovery to the clinic in only three years. AVEO has built a state-of-the-art antibody drug discovery platform which has yielded a rich pipeline of more than 10 currently un-partnered programs dedicated to the delivery of novel, high-quality oncology antibody drug candidates,” stated Elan Ezickson, chief business officer.  “Our next most advanced antibody program is the AV-370 program, a member of the FGFR family.  The progress with SCH900105 (AV-299), combined with our significant progress with AV-951, our orally delivered, triple VEGF receptor inhibitor which recently completed enrollment in a Phase 2 clinical trial in patients with metastatic renal cell cancer, demonstrates AVEO’s unique ability to advance a balanced portfolio of high-value antibodies and small molecules.”
 
About SCH900105 (AV-299)
SCH900105 (AV-299) is a highly potent antagonist of hepatocyte growth factor/scatter factor (HGF/SF), which has demonstrated excellent activity in preclinical models of human cancer. AVEO’s SCH900105 (AV-299) program exemplifies the progress AVEO has made in discovering drugs that target functionally-relevant tumor maintenance genes identified and validated by AVEO in its proprietary in vivo cancer models. To guide the clinical development of SCH900105 (AV-299), AVEO is using its proprietary, genetically engineered models of human cancer to identify specific characteristics of tumors in which the HGF/c-Met pathway plays a critical role in tumor maintenance, as opposed to those in which the pathway is activated but not essential. 

About AVEO and Schering-Plough Global Partnership
On April 4th, 2007, AVEO announced that it had entered an exclusive worldwide license and development agreement with Schering-Plough for SCH900105 (AV-299).  AVEO will have primary responsibility for clinical development of SCH900105 (AV-299) through proof-of-concept in man and will apply its HRPTM platform during a multi-year translational research program designed to discover biomarker profiles of patients most likely to benefit from treatment with SCH900105 (AV-299).  AVEO retains the option to co-promote SCH900105 (AV-299) in the United States for certain oncology indications. Under the terms of the deal, AVEO received a $7.5 million upfront payment and a $10 million equity investment from Schering-Plough. Schering-Plough will fund all research and development expenses.  Milestone payments for the successful development and commercialization of SCH900105 (AV-299), if all approvals in multiple indications and all sales milestones are achieved, could exceed $460 million. Upon commercialization, AVEO is eligible to receive royalties on net sales. 

About AVEO
AVEO is a clinical-stage 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, FGFR), as well as collaborations with Eli Lilly, 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 www.aveopharma.com.

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