AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that new clinical data from a Phase 1b trial evaluating the company’s lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with FOLFOX6, a standard chemotherapy regimen, will be presented during the 22nd Annual Symposium of the European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research (EORTC-NCI-AACR) being held November 16-19, 2010 in Berlin, Germany. Additional preclinical data evaluating tivozanib in AVEO’s proprietary tumor models and preclinical data from the company’s anti-fibroblast growth factor receptor (FGFR) antibody program will also be presented.
“We look forward to sharing these new data from our ongoing clinical trial evaluating tivozanib in combination with FOLFOX6 chemotherapy regimen with our peers in the oncology community,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “Tivozanib is the most potent and selective inhibitor of VEGF receptors 1, 2 and 3, and we believe tivozanib’s promising tolerability and efficacy profile suggests the potential for broad applicability and combinability with chemotherapies and other targeted agents in multiple tumor types.”
The schedule for AVEO poster presentations at EORTC-NCI-AACR is as follows:
Date & Time: Wednesday, November 17, 2010 at 12:00 p.m. (CET)
Poster Category: Molecular-targeted therapies-preclinical
Poster Title: Tivozanib activity in combination with capecitabine, 5-fluorouracil (5-FU), or docetaxel, in traditional or engineered subcutaneous breast tumor models
Abstract Number: 90
Presenter: Jie Lin
Date & Time: Wednesday, November 17, 2010 at 12:00 p.m. (CET)
Poster Category: Monoclonal antibodies and targeted toxins/nuclides/agents
Poster Title: Essential role of fibroblast growth factor receptor 2 (FGFR2) in tumorigenesis of human cancers harboring FGFR2 amplification demonstrated by a functional blocking antibody
Abstract Number: 230
Presenter: Ailin Bai
Date & Time: Thursday, November 18, 2010 at 12:00 p.m. (CET)
Poster Category: Molecular-targeted therapies-clinical trials
Poster Title: A Phase 1b study of escalating doses of vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor tivozanib and FOLFOX6 in patients with advanced gastrointestinal (GI) tumors
Abstract Number: 370
Presenter: Ferry Eskens
Date & Time: Friday, November 19, 2010 at 8:00 a.m. (CET)
Poster Category: Biomarkers
Poster Title: Tivozanib biomarker identifies tumor infiltrating myeloid cells contributing to tivozanib resistance in both preclinical models and human renal cell carcinoma
Abstract Number: 608
Presenter: Jie Lin
In addition, Robert Motzer, M.D., attending physician at Memorial Sloan-Kettering Cancer Center and lead investigator of TIVO-1, a global Phase 3 clinical trial evaluating tivozanib compared to sorafenib in patients with advanced renal cell cancer (RCC), will report on previously presented tivozanib clinical data in patients with advanced RCC at 9:50 a.m. (EST) on November 12, 2010 during the 28th Annual Chemotherapy Foundation Symposium (CFS) at the Marriott Marquis in New York City.
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. The EMA has granted AVEO orphan medicinal product designation for tivozanib for the treatment of RCC.
AVEO recently completed patient enrollment ahead of schedule in TIVO-1, a global, randomized (1:1), controlled Phase 3 clinical trial evaluating tivozanib compared to sorafenib (Nexavar®) in patients with RCC. The company has initiated a series of clinical trials evaluating tivozanib in combination with other agents in multiple solid tumor settings, including an ongoing Phase 1b trial in combination with temsirolimus (Torisel®), an approved mTOR inhibitor, in patients with metastatic renal cell carcinoma; a Phase 1b trial in combination with the FOLFOX6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers; and a Phase 1b trial in combination with paclitaxel (Taxol®) in patients with metastatic breast cancer. A Phase 1b trial evaluating tivozanib as monotherapy in patients with non-small cell lung cancer is also being conducted.
AVEO is also utilizing its Human Response Platform™ (HRP) in its efforts to help identify rational drug combinations and patient populations most likely to be responsive to these combination therapies.
About AVEO’s FGF Program
Fibroblast growth factors, or FGFs, and their receptors, FGFR1-4, represent a signaling network that plays important roles in the regulation of cell growth, survival, differentiation and angiogenesis. Through its HRP, AVEO has identified FGF ligands and receptors as powerful drivers of tumor growth in a variety of tumor models and implicated the activation of the pathway in tumor development.
Certain FGF ligands have been shown to have pro-angiogenic activity and may act synergistically with VEGF to amplify tumor angiogenesis. The upregulation of FGF pathway activity in response to anti-VEGF therapy is thought to play an important role in the development of resistance to VEGF inhibition, suggesting that the combination of FGF and VEGF pathway inhibitors may add to the benefits achievable by targeting VEGF alone.
The goal of AVEO’s ongoing drug discovery efforts is to identify specific FGFR1, FGFR2, FGFR3 and FGFR4 inhibitory antibodies that prevent activation of these receptors. AVEO plans to evaluate the activity of candidate antibodies in specific target-driven tumor models created using the company’s HRP.
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 a highly differentiated 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 second most advanced product candidate, AV-299, is a potent, functional anti-HGF antibody that is currently in Phase 2 development. AVEO’s proprietary, integrated cancer biology platform offers the company a unique advantage in oncology drug development and has provided 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 tivozanib’s promising tolerability and efficacy profile suggesting the potential for broad applicability and combinability with other therapeutic agents; the anticipated combinability of tivozanib potentially increasing the breadth of its clinical utility; the hypothesis that certain FGF ligands may act synergistically with VEGF to amplify tumor angiogenesis; the potential that the combination of FGF and VEGF pathway inhibitors may add to the benefits achievable by targeting VEGF alone; our ability to identify specific FGFR inhibitory antibodies; our cancer biology platform offering a unique advantage in oncology drug development; 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; the possibility that favorable data from our Phase 2 clinical trials of tivozanib may not be predictive of the results in TIVO-1 and our other clinical trials; delays in data availability, or negative results from our clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of our program candidates; competition; 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.
AVEO Pharmaceuticals, Inc.
Monique Allaire, 617-299-5810
Caton Lovett, 910-232-7166