AVEO Initiates the Evaluation of Tivozanib in Combination with Bristol-Myers Squibb’s Opdivo® (nivolumab) in Advanced Rena...
August 15 2016 - 07:00AM
Business Wire
-Phase 1/2 TiNivo Trial to Commence at the
Institut Gustave Roussy in Paris-
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.
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Argot Partners for AVEO:David Pitts, (212)
600-1902aveo@argotpartners.com
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