AVEO Oncology Announces Immuno-Oncology Clinical Collaboration with AstraZeneca
December 12 2018 - 7:00AM
Business Wire
Phase 1/2 Study will Evaluate Combination of
IMFINZI® (durvalumab) and FOTIVDA® (tivozanib) in First-Line
HCC
AVEO Oncology (NASDAQ: AVEO) today announced that it has entered
into a clinical collaboration with AstraZeneca to evaluate the
safety and efficacy of AstraZeneca's IMFINZI® (durvalumab), a human
monoclonal antibody directed against programmed death-ligand 1
(PD-L1), in combination with FOTIVDA® (tivozanib), AVEO’s oral,
once-daily, potent and highly-selective vascular endothelial growth
factor receptor tyrosine kinase inhibitor (VEGFR-TKI) in first-line
hepatocellular carcinoma (HCC), or liver cancer, in a Phase 1/2
study.
AVEO will serve as the study sponsor, with study costs shared
equally by both parties and clinical drug supplied by each
respective company. The Phase 1 portion of the study is expected to
commence in 2019.
“We are thrilled to collaborate with AstraZeneca to explore
another tivozanib-immunotherapy combination and look forward to
understanding the potential of combining tivozanib with durvalumab
in liver cancer,” said Michael Bailey, president and chief
executive officer of AVEO. “TKI-immunotherapy combinations have
demonstrated important clinical potential across multiple tumor
types, though toxicities associated with these combinations have
limited their potential use. Our goal is to establish tivozanib as
the TKI of choice for use with immunotherapies by demonstrating
efficacy with reduced toxicity.”
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 Durvalumab (IMFINZI®)
Durvalumab (IMFINZI®) is a human monoclonal antibody that binds
to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80,
countering the tumor's immune-evading tactics and releasing the
inhibition of immune responses. As part of a broad development
program, durvalumab is being investigated as monotherapy and in
combination with immuno-oncology (IO) agents, small molecules, and
chemotherapies across a range of tumors and stages of disease.
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: the potential efficacy, safety, and
tolerability of tivozanib, as a single agent and in combination
with durvalumab in liver cancer and other indications; timing for
commencement of the Phase 1 portion of the study; the potential for
tivozanib to address the limits of other TKI-immunotherapy
combinations; the potential for tivozanib to be established as the
TKI of choice for use with immunotherapies; AVEO’s plans and
strategies for commercialization of tivozanib in the United States
and Europe; the potential for tivozanib in RCC, HCC and other
indications; 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 for its product
candidates and for the Company generally. 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 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 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 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; 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20181212005211/en/
AVEO Contact:David Pitts, Argot Partners(212)
600-1902aveo@argotpartners.com
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