AVEO Pharmaceuticals regained worldwide rights from Merck & Co. to develop and commercialize AV-299, an antihepatocyte growth factor (HGF) antibody candidate. “The decision to return this program to AVEO is a result of portfolio prioritization,” according to David Nicholson, Ph.D., svp and head of worldwide licensing and knowledge management at Merck.
AV-299 is a potent, functional anti-HGF antibody that was discovered by AVEO through its Human Response Platform™. In April 2007, the firm granted Schering worldwide rights to develop and commercialize AV-299. Schering was subsequently acquired by Merck in March 2009 for almost $42 billion. Merck then took over funding all R&D expenses related to AV-299 as per the original deal between AVEO and Schering.
AVEO had retained primary responsibility for certain development activities through completion of the first Phase II proof-of-concept trial and for conducting translational research to guide clinical development. It also had the option to co-promote AV-299 in the U.S. for certain oncology indications.
Data from Phase I trials suggests a favorable tolerability profile and good combinability with EGFR inhibitors Tarceva and Iressa. The HGF/c-Met pathway is believed to play an important role in regulating tumor growth, invasion, and metastasis. Preclinical and clinical observations suggest that increased HGF and/or c-Met receptor amplification may confer resistance to EGFR inhibitors, AVEO explains.
In June AVEO initiated a Phase II study evaluating AV-299 in combination with Iressa versus Iressa monotherapy in patients with non-small-cell lung cancer (NSCLC). Data is expected in late 2011. In conjunction with start of the Phase II trial, AVEO received an $8.5 million milestone payment from Merck under the terms of their license agreement.
“AVEO now holds significant commercialization rights to all oncology products in our pipeline, and we believe that we are well-positioned to move toward our goal of becoming a fully integrated commercial organization,” remarks Tuan Ha-Ngoc, president and CEO of AVEO Pharmaceuticals. “Our expected year-end 2010 cash balance remains unchanged, and we reaffirm that AVEO has sufficient capital to take us beyond data from TIVO-1, our ongoing Phase III clinical trial of tivozanib in patients with renal cell carcinoma. We look forward to sharing top-line TIVO-1 data in mid-2011.”
TIVO-1 is a global, randomized Phase III trial comparing AVEO’s lead product, tivozanib, to Nexavar in advanced kidney cancer. The drug, an oral, triple VEGF receptor inhibitor, is also being tested in additional clinical studies in other solid tumor types.