Press Release

U.S. Patent & Trademark Office Allows AVEO Oncology’s Patent Application Covering Use of FOTIVDA® for the Treatment of Refractory Advanced Renal Cell Carcinoma

Oct 12 | 2022

BOSTON, Oct. 12, 2022 (GLOBE NEWSWIRE) -- AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, announced today that, as disclosed on uspto.gov, the United States Patent and Trademark Office (“USPTO”) has allowed U.S. Patent Application No. 17/720,619, titled “Use of Tivozanib to Treat Subjects with Refractory Cancer” (the “Application”). AVEO expects to receive a Notice of Allowance for this Application. This Application will potentially issue as a patent in 2022 and will provide patent protection in the United States for the claimed methods of use of FOTIVDA into 2039.

A Notice of Allowance is issued after the USPTO decides that a patent can be granted from a patent application. The majority of patent applications that receive a Notice of Allowance will issue as a U.S. patent once the issue fee is paid. However, a Notice of Allowance is not a guarantee of patent issuance.

“We are pleased by the progress we have made at the United States Patent and Trademark Office and the continued recognition of FOTIVDA to treat refractory advanced RCC in subjects who have received at least two prior anti-cancer therapies,” said Michael Bailey, AVEO’s president and chief executive officer. “When issued, this patent is expected to provide a potential barrier for generic entry. It is part of our broader life cycle management strategy and is designed to extend the commercial opportunity of FOTIVDA, following a long development path and a relatively short exclusivity period since FOTIVDA’s approval by the U.S. Food and Drug Administration in March 2021.”

If issued, AVEO plans to list this patent in the United States Food and Drug Administration’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations as it relates to FOTIVDA with an expiration date of November 5, 2039.

About FOTIVDA® (tivozanib)

FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.2 FOTIVDA was discovered by Kyowa Kirin.

About Advanced Renal Cell Carcinoma

According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.3 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,4 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.

About AVEO Pharmaceuticals, Inc.

AVEO is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the company.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 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 “advance,” “aim,” “anticipate,” “believe,” “continue,” “could,” “design,” “estimate,” “expect,” “goal,” “intend,” “look forward,” “may,” “plan,” “potential,” “project,” “promising,” “seek,” “should,” “strategy,” “will,” “would,” 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: AVEO’s expectation that the USPTO will issue a patent from the allowed application in 2022; AVEO’s patent portfolio and life cycle management strategy; the potential for FOTIVDA as a treatment option for patients with relapsed or refractory advanced RCC; the potential efficacy, safety and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in other indications; AVEO’s ability to advance FOTIVDA’s use and approval as a monotherapy or in combination with other products through clinical trials; and AVEO’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection for FOTIVDA and its other product candidates. 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 obtain and maintain adequate protection for intellectual property rights relating to FOTIVDA and its product candidates; unplanned capital requirements; adverse general economic, political and industry conditions; the potential adverse effects of the COVID-19 pandemic on AVEO’s business continuity, financial condition, results of operations, liquidity and ability to commercialize FOTIVDA, manufacture clinical and commercial product and timely initiate new trials or complete its ongoing clinical trials; competitive factors; and those risks discussed in the sections titled “Risk Factor Summary,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s quarterly and annual reports on file with the Securities and Exchange Commission (SEC) and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release, and 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.

Any reference to AVEO’s website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.

References

  1. ZS Associates. US emerging pharma and biotech first launches: A story of over-and underperformance. June 21, 2022.
  2. Pawlowski N et al. AACR 2013. Poster 3971.
  3. J Angulo and O Shapiro, Cancers (Basel) 2019 Sep; 11(9): 1227. [10.3390/cancers11091227]
  4. Decision Resources. RCC landscape and forecast. December 12, 2019.

AVEO Investor Relations Contact:
Hans Vitzthum
LifeSci Advisors
(617) 430-7578
hans@lifesciadvisors.com

AVEO Public Relations Contact:
John F. Kouten
JFK Communications, Inc.
(609) 241-7352
jfkouten@jfkhealth.com

 


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Source: AVEO Pharmaceuticals, Inc.