May 2, 2016

AVEO Announces Filing of Provisional Patent Applications for AV-353, a Notch 3-Specific Inhibitor Antibody for PAH

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CAMBRIDGE, Mass.–(BUSINESS WIRE)–May 2, 2016– AVEO Oncology (NASDAQ:AVEO) today announced that it has filed provisional patent applications with the United States Patent and Trademark Office (USPTO) covering composition of matter claims for AV-353, the Company’s potent inhibitory antibody specific to Notch 3. These patent applications are the second set of applications related to AV-353 and the Company’s Notch 3 antibody program.

The Notch 3 signaling pathway is important in cell-to-cell communication involving gene regulation mechanisms that control multiple cell differentiation processes during the entire life cycle. Scientific literature has implicated the Notch 3 receptor pathway in multiple diseases, including cancer, cardiovascular diseases and neurodegenerative conditions. Recent publications, including Nature Medicine (2009), have implicated the Notch 3 pathway in Pulmonary Arterial Hypertension (PAH). PAH is a rare and life-threatening disorder that affects approximately 250,000 people worldwide and is caused by enlargement of the arterial walls in small arteries between the heart and the lungs, resulting in restricted blood flow.

Current treatments in PAH focus only on controlling symptoms by avoiding vasoconstriction and increasing vasodilation of vessels and do not reverse the underlying cause of the disease. In contrast, with the results of a recently concluded research study supported by AVEO, AV-353 has generated a growing body of preclinical data that supports AV-353’s ability to potentially reverse the disease phenotype, which would represent a potential disease-modifying approach to treatment. A manuscript of the results is being prepared for submission to a peer-reviewed journal.

“Like AV-380 in cachexia, which AVEO licensed to Novartis in 2015, AV-353 is an AVEO legacy discovery program that, with the appropriate development support from a partner, has the potential to transform the treatment paradigm for a debilitating disorder and underserved patient population,” said Michael Bailey, president and chief executive officer of AVEO. “We believe that AV-353’s selectivity and high affinity to Notch 3, as demonstrated in preclinical studies, makes it unique relative to pan-notch inhibitory or ligand inhibitory approaches in PAH treatment, allowing us to potentially build a broad patent estate around this program. Consistent with our current focus on developing oncology therapeutics, AVEO is currently seeking an appropriate partner to develop and commercialize AV-353 worldwide in PAH.”

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 qualities, uniqueness, expected benefits and potential of AV-353; the potential for AV-353 to be a disease-modifying treatment; the potential for AV-380 and AV-353 to transform treatment paradigms; the potential patentability of AV-353; AVEO’s plans to partner AV-353 and AVEO’s focus on developing and commercializing tivozanib and other oncology therapeutics. 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 enter into new partnerships and maintain its licensing agreements, including for AV-353 and AV-380, and its ability, and the ability of its licensees, to achieve development and commercialization objectives under these arrangements; 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 successfully implement its strategic plans; AVEO’s ability to successfully enroll and complete clinical trials of its product candidates; 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 raise the substantial 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

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