CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 2, 2019--
AVEO Oncology (NASDAQ: AVEO) today announced that data from the Phase 3
TIVO-3 study of tivozanib (FOTIVDA®) versus sorafenib in
refractory advanced or metastatic renal cell carcinoma (RCC) will be
presented during an oral session at the 2019 American Society of
Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium being held
February 14-16, 2019 in San Francisco.
Presentation Details
Title: TIVO-3: A phase III, randomized, controlled, multicenter,
open-label study to compare tivozanib to sorafenib in subjects with
refractory advanced renal cell carcinoma (RCC)
Presenter:Brian Rini, MD, Cleveland Clinic Lerner College of Medicine of Case
Western Reserve University
Abstract Number: 541
Session
Title: General Session 8: Evolving Management of Metastatic Renal
Cell Carcinoma
Data and Time: February 16, 2019, 10:00
a.m.-11:30 a.m. PT
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Hakko Kirin and approved for the treatment of adult
patients with advanced renal cell carcinoma (RCC) in the European Union
plus Norway and Iceland. 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.1,2
Tivozanib has been shown to significantly reduce regulatory T-cell
production in preclinical models3, and has demonstrated
synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in
RCC. Tivozanib has been investigated in several tumors types, including
renal cell, hepatocellular, colorectal and breast cancers.
About AVEO
AVEO Pharmaceuticals, Inc. (the “Company” or “AVEO”) is a
biopharmaceutical company dedicated to advancing a broad portfolio of
targeted medicines for oncology and other areas of unmet medical need.
The Company’s strategy is to retain North American rights to its
oncology portfolio while securing partners in development and
commercialization outside of North America. The Company is seeking to
develop and commercialize its lead candidate tivozanib in North America
as a treatment for advanced or metastatic renal cell carcinoma (“RCC”).
The Company has outlicensed tivozanib (FOTIVDA®) for oncological
indications in Europe and other territories outside of North America.
Tivozanib is approved in the European Union, as well as Norway and
Iceland, for the first-line treatment of adult patients with RCC and for
adult patients who are vascular endothelial growth factor receptor and
mTOR pathway inhibitor-naïve following disease progression after one
prior treatment with cytokine therapy for RCC. The Company has entered
into partnerships for the development and commercialization of AV-203
(CAN017) and ficlatuzumab, both clinical stage assets in oncology. The
Company is currently seeking a partner to develop the AV-353 platform, a
preclinical asset, worldwide for the potential treatment of pulmonary
arterial hypertension and oncology. In addition, a new formulation of
tivozanib is being explored in ocular conditions. The Company has
recently regained the rights to its AV-380 program for the potential
treatment of cachexia and is considering a variety of options to advance
the program’s development.
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, statements about: AVEO’s plans to present data
from the TIVO-3 study in the first half of 2019, including updated
overall survival data; AVEO’s plans and timing estimates regarding the
potential submission of a New Drug Application to the FDA for tivozanib
in the first half of 2019; AVEO’s plans and strategies for
commercialization of tivozanib in the United States and Europe; the
potential for tivozanib in RCC and other indications, such as ocular
conditions, and as either a monotherapy or combination therapy; AVEO’s
plan to seek a partner to develop the AV-353 platform; AVEO’s plans
regarding AV-380; AVEO’s cash runway; and AVEO’s strategy, prospects,
plans and objectives, including its plans to advance its portfolio of
targeted medicines. AVEO has based its expectations and estimates on
assumptions that may prove to be incorrect. As a result, readers are
cautioned not to place undue reliance on these expectations and
estimates. 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 and maintain
its third party collaboration and license agreements, and its ability,
and the ability of its collaborators, licensees, and other strategic
partners, to achieve development and commercialization objectives under
these arrangements; and AVEO’s ability, and the ability of its
licensees, to demonstrate to the satisfaction of applicable regulatory
agencies such as the FDA the safety, efficacy and clinically meaningful
benefit of AVEO’s product candidates, including tivozanib. AVEO faces
other risks relating to its business as well, including risks relating
to the timing and costs of any product candidate seeking and obtaining
regulatory approval; AVEO’s ability to file an NDA for tivozanib in the
timeframe it currently estimates or at all; AVEO’s and its
collaborators’ ability to successfully enroll and complete clinical
trials; AVEO’s ability to achieve and maintain compliance with
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;
AVEO’s ability to successfully implement its strategic plans; AVEO’s
ability to raise the substantial additional funds required to 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 sections titled “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 may make with the SEC in the
future. 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. Fotivda (Tivozanib) SmPC August 2017
2.
Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9.
3.
Pawlowski N et al. AACR 2013. Poster 3971.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190102005143/en/
Source: AVEO Oncology
AVEO Contact:
David Pitts, Argot Partners
(212) 600-1902
aveo@argotpartners.com