AVEO Announces First Patient Dosed in Phase 1/2 TiNivo Trial of Tivozanib and Opdivo® (nivolumab) in Advanced RCC
March 22 2017 - 7:00AM
Business Wire
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170322005557/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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