AVEO Announces Acceptance of CANbridge Investigational New Drug Application for CAN017 (AV-203) Trial in Esophageal Squamous ...
August 14 2018 - 8:00AM
Business Wire
- IND acceptance triggers $2M milestone payment
from CANbridge to AVEO -
AVEO Oncology (Nasdaq: AVEO) today announced that the China
National Drug Administration (CNDA) has accepted CANbridge Life
Sciences’ Investigational New Drug (IND) Application for a Phase
Ib/III clinical trial of CAN017 (AV-203), AVEO’s clinical-stage
ErbB3 (HER3) inhibitory antibody candidate, in esophageal squamous
cell cancer (ESCC).
Under the terms of a March 2016 agreement, the acceptance of
this IND triggers a $2 million milestone payment to AVEO from
CANbridge Life Sciences. CANbridge licensed worldwide rights,
excluding the United States, Canada, and Mexico, to AV-203 from
AVEO and AVEO is eligible to receive up to $40 million in potential
additional development and regulatory milestone payments and up to
$90 million in potential commercial milestone payments, assuming
the successful achievement of specified development, regulatory and
commercialization objectives.
“CANbridge continues to make progress in advancing CAN017, and
we look forward to the initiation of a Phase Ib/extension clinical
trial in ESCC, a large unmet medical need globally with a
particularly acute need in Asia,” said Michael Bailey, president
and chief executive officer of AVEO. “Together with ficlatuzumab,
our partnered oncology programs allow us to retain meaningful
rights to a promising pipeline and advance it at little or no cost
to AVEO, allowing us to focus resources on our tivozanib strategy,
including U.S. registration for kidney cancer as well as
combinations with immunotherapy.”
AVEO previously completed a Phase 1, open-label, dose-escalation
study of AV-203 (CAN017) in patients with advanced solid tumors. In
this study, AV-203 was found to be generally safe and
well-tolerated, with an early signal of activity consistent with
preclinical data showing the potential for heregulin or neuregulin,
the only known ligand for ErbB3, to serve as a biomarker predictive
of AV-203 anti-tumor activity.
AVEO will pay percentage of the milestone payment to Biogen Idec
International GmbH as a sublicensing fee.
About AVEO
AVEO Pharmaceuticals, Inc. (the “Company”) 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 renal cell carcinoma (“aRCC”).
The Company has outlicensed tivozanib (FOTIVDA®) for oncology 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 aRCC 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 aRCC. The Company has
entered into partnerships to fund 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. The Company previously partnered with Novartis
International Pharmaceutical Ltd. (“Novartis”) to develop the
AV-380 program in cachexia and other indications. Effective August
28, 2018, the Company expects to regain the rights to AV-380 and is
considering a variety of options to continue 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 progress of future clinical trials of
CAN017; the advancement of AVEO’s pipeline and costs associated
with such advancement; the achievement of development, regulatory
and commercialization objectives by CANbridge; AVEO’s cash runway;
and AVEO’s strategy, prospects, plans and objectives, including as
they pertain specifically to tivozanib and leveraging partnerships.
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 its
and its collaborators’ ability to successfully enroll and complete
clinical trials, including the TIVO-3 and TiNivo studies; 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; 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 section 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. 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. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180814005210/en/
For AVEO:Argot PartnersDavid Pitts, 212-600-1902
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