August 15, 2016

AVEO Initiates the Evaluation of Tivozanib in Combination with Bristol-Myers Squibb’s Opdivo® (nivolumab) in Advanced Renal Cell Carcinoma

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–Phase 1/2 TiNivo Trial to Commence at the Institut Gustave Roussy in Paris-

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 15, 2016– AVEO Oncology (NASDAQ:AVEO) today announced the initiation of a clinical evaluation of AVEO’s oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), tivozanib, in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo® (nivolumab), in advanced renal cell carcinoma (RCC). Bristol-Myers Squibb will supply nivolumab for use in the Phase 1/2 AVEO-sponsored TiNivo trial. The trial will be led by the Institut Gustave Roussy in Paris under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee.

The Phase 1 trial will evaluate tivozanib in combination with nivolumab at escalating doses of tivozanib in patients with advanced RCC, and will be followed by an expansion Phase 2 cohort at the established combination dose.

“The introduction of immunotherapies has greatly improved outcomes in renal cell carcinoma, and combination therapy is the obvious next step in advancing treatment,” said Professor Escudier. “There is already early evidence that combining VEGF inhibitors with immune checkpoint inhibitors can improve outcomes, but tolerability of the combination and, in particular, avoiding overlapping liver toxicities, fatigue and stomach disorders is critical to ensuring that both therapies can be delivered at effective levels. Tivozanib’s distinct tolerability profile among VEGF TKIs makes it a potentially unique candidate for use with nivolumab. I look forward to enrolling this study and to understanding how this combination translates to the clinic.”

“Research suggests that, because VEGF inhibition may limit the presence of immunosuppressive cells, VEGF therapy may be an ideal primer and a natural combination for improving the efficacy of anti-PD-1 therapies such as nivolumab, which are designed to reveal the tumor to the immune system,” said Michael Needle, MD, chief medical officer of AVEO. “This study has the potential to unlock a more effective, better tolerated new treatment approach in RCC. We appreciate Bristol-Myers Squibb’s support for this study, and we look forward to working with Dr. Escudier and his team to fully understand this potential.”

About Tivozanib

Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The company is focused on developing and commercializing its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for Renal Cell Carcinoma and other cancers. AVEO is leveraging multiple partnerships to develop and commercialize tivozanib in non-oncologic indications worldwide and oncology indications outside of North America, as well as to progress its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). For more information, please visit the company’s website at www.aveooncology.com.

AVEO Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the potential efficacy, mechanism of action and tolerability of VEGF inhibitors in combination with immune checkpoint inhibitors; the potential efficacy and tolerability of tivozanib as a single agent and in combination with nivolumab; and the expected development and commercialization of tivozanib. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability, and the ability of its partners, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; AVEO’s ability, and the ability of its clinical partners, to successfully enroll and complete clinical trials of its product candidates, including the TiNivo trial; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to AVEO’s ongoing shareholder litigation; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to raise additional funds required to achieve its goals; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.

Source: AVEO Oncology

Argot Partners for AVEO:
David Pitts, (212) 600-1902
aveo@argotpartners.com