Announces Decision to Fund Clinical Manufacture
of Ficlatuzumab for Potential Phase 3 Study and Update to Biodesix
Partnership
No Change to AVEO Cash Runway Guidance
AVEO Oncology (Nasdaq: AVEO) today announced that it has
regained full global rights to ficlatuzumab, AVEO’s potent
hepatocyte growth factor (HGF) inhibitory antibody which binds to
the HGF ligand with high affinity and specificity to inhibit
HGF/c-Met biological activities. AVEO also announced today that it
plans to fund the clinical manufacture of ficlatuzumab to enable a
potential registrational Phase 3 clinical trial in head and neck
squamous cell cancer (HNSCC), as well as additional potential
development in Phase 2 studies in pancreatic cancer and acute
myeloid leukemia (AML). Following the decision, Biodesix, a leading
diagnostic company, has exercised its contractual right to reduce
its future financial obligations in exchange for reduced
partnership economics. Under the terms of the agreement between
AVEO and Biodesix, Biodesix will continue to fund 50% of the
ongoing HNSCC Phase 2 trial, and will be entitled to a low double
digit royalty on any future product sales as well as 25% of future
licensing revenue, subject to certain limitations.
“We are very pleased to regain full rights to another late-stage
asset. This comes at a strategic point in our Company’s history, as
we continue to build a commercial biopharmaceutical company with a
broad oncology portfolio that has the potential to enable a
long-term, sustainable growth model,” said Michael Bailey,
president and chief executive officer of AVEO. “The early data we
have seen in the randomized, open-label HNSCC study with
ficlatuzumab combined with cetuximab (ERBITUX®) has led us to the
decision to secure additional clinical manufacturing capacity,
which we expect to fund within our previously announced cash runway
guidance, in order to prepare for a potential HNSCC pivotal study.
We look forward to presenting final results from the Phase 2 study
in the middle of 2021, and to providing an update on our potential
pivotal program within that timeframe.”
Ficlatuzumab is being studied in an ongoing randomized,
open-label confirmatory Phase 2 study in combination with
cetuximab, an EGFR-targeted antibody, in cetuximab-resistant,
recurrent metastatic HNSCC. The study was designed to confirm
findings from a Phase 1 study of ficlatuzumab and cetuximab where
the combination was well tolerated and resulted in a disease
control rate of 67%, as well as prolonged progression free and
overall survival compared to historical controls. The Phase 2
multi-center study is being conducted under the direction of Julie
E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of
Hematology/Oncology, Associate Director of Translational Research,
University of Arizona Cancer Center. Enrollment is expected to
conclude in the fourth quarter of 2020, and results from the study
are expected to be presented at a scientific meeting in 2021.
For more information, please refer to the Current Report on Form
8-K which will be filed by AVEO with the U.S. Securities &
Exchange Commission on September 8, 2020.
About AVEO Pharmaceuticals, Inc.
AVEO is developing an oncology pipeline designed to provide a
better life for patients with cancer. AVEO’s strategy is to focus
its resources toward development and commercialization of its
product candidates in North America, while leveraging partnerships
to support development and commercialization in other geographies.
AVEO’s lead candidate, tivozanib (FOTIVDA®) is approved in the
European Union and other countries in the EUSA territory for the
treatment of adult patients with advanced renal cell carcinoma.
AVEO is working to develop and potentially commercialize tivozanib
in North America as a treatment for renal cell carcinoma and
hepatocellular carcinoma. AVEO has previously reported promising
early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck
cancer, acute myeloid leukemia and pancreatic cancer and is
conducting a randomized Phase 2 confirmatory clinical trial of
ficlatuzumab in head and neck cancer. AVEO’s earlier-stage pipeline
includes several monoclonal antibodies in oncology development,
including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and
AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an
environment of diversity and inclusion as a foundation for
innovation.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements of AVEO
within the meaning of the Private Securities Litigation Reform Act
of 1995 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,” “hope,” “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 advancement of AVEO’s pipeline,
including the advancement of ficlatuzumab in multiple clinical
studies; the potential efficacy, safety, and tolerability of
ficlatuzumab, both as a stand-alone drug candidate and in
combination with other therapies; the potential for outcomes from
studies of ficlatuzumab to provide AVEO with opportunities to
pursue regulatory strategies; the potential clinical utility of
ficlatuzumab in areas of unmet need; the potential for tivozanib as
a treatment option for patients with advanced HCC or
relapsed/refractory or advanced RCC; the potential efficacy,
safety, and tolerability of tivozanib, both as a stand-alone drug
candidate and in combination with other therapies in several
indications; AVEO’s execution of its clinical and regulatory
strategy for tivozanib; AVEO’s plans and strategies for current and
future clinical trials of tivozanib, ficlatuzumab and AV-380 and
for commercialization of tivozanib in the United States; AVEO’s
expectations about its cash runway and its cash runway guidance;
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: whether the results of TIVO-3 are sufficient to obtain
marketing approval for tivozanib in the U.S., which turns on the
ability of AVEO to demonstrate to the satisfaction of the FDA the
safety and efficacy of tivozanib based upon the findings of TIVO-3,
including its data with respect to PFS, the rate of adverse events,
OS and other information that the FDA may determine for approval;
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, in particular, tivozanib and
ficlatuzumab; and 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. 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 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, including its ability to successfully launch and
commercialize tivozanib if it may be approved for commercialization
by the FDA; 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; AVEO’s ability to access up to
$20.0 million of the Hercules loan facility, which turns on the
achievement of milestones related to the approval and
commercialization of tivozanib in the U.S., which milestones may
not be achieved; adverse general economic and industry conditions;
the potential adverse effects of the COVID-19 pandemic on AVEO’s
business continuity, financial condition, results of operations,
liquidity and ability to successfully and timely enroll, complete
and read-out data from its clinical trials; 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 makes with
the SEC. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200908005259/en/
AVEO Contact: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
AVEO Pharmaceuticals (NASDAQ:AVEO)
Historical Stock Chart
From Aug 2024 to Sep 2024
AVEO Pharmaceuticals (NASDAQ:AVEO)
Historical Stock Chart
From Sep 2023 to Sep 2024