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AVEO Announces First Patient Dosed in Phase 1/2 TiNivo Trial of Tivozanib and Opdivo® (nivolumab) in Advanced RCC

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 22, 2017-- AVEO Oncology (NASDAQ:AVEO) today announced that the first patient has been dosed in the Phase 1/2 AVEO-sponsored TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo® (nivolumab), in advanced renal cell carcinoma (RCC). The study, which will be led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1 trial will evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib and, assuming favorable results, is expected to be followed by an expansion Phase 2 cohort at the established combination dose.

“There is compelling scientific rationale for combining the antiangiogenic activity of VEGF inhibition with the immunologic activity of PD-1 inhibitors. Yet, to date, the tolerability of these combinations have been a challenge with currently approved VEGF TKIs and PD-1s,” said Professor Escudier. “Tivozanib has been demonstrated to be the most selective VEGF inhibitor, delivering a uniquely favorable tolerability profile in past single agent and combination studies, and has the potential for minimal overlapping toxicities with immunotherapies. I look forward to understanding the clinical potential of combining tivozanib and nivolumab in the TiNivo study, and to the prospect of further improving outcomes in this very dynamic treatment area.”

“VEGF-PD-1 combinations have yielded promising tumor response outcomes in renal cell cancer, yet the data presented to date point to challenging or prohibitive toxicity,” said Michael Bailey, president and chief executive officer of AVEO. “We believe tivozanib offers a unique opportunity to potentially overcome this barrier, and look forward to initial results from the Phase 1 portion of the TiNivo trial in the first half of 2017.”

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 seeking to develop and commercialize 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 aimed at developing and commercializing 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.

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," "potential", "could," "should," “would,” "seek," “look forward,” “advance,” “goal,” “strategy,” 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: AVEO’s expectations that it will receive initial results from the TiNivo study in the first half of 2017 and the potential advancement of such trial; the potential safety, efficacy, tolerability and other benefits of tivozanib in the treatment of renal cell carcinoma as a single agent or in combination with other therapies including immunotherapy such as nivolumab; and AVEO’s plans, strategies and goals for its business. 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 to successfully enroll and complete clinical trials, including the TiNivo trial; AVEO's ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO's product candidates; AVEO's ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO's ability to enter into and maintain its third party collaboration agreements, and its ability, and the ability of its licensees and other partners, to achieve development and commercialization objectives under these arrangements; 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 the substantial additional funds required to continue to fund its working capital requirements and achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; 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

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