- Data Presented at the 2020 ASCO GI Cancers
Symposium -
AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. today announced
the presentation of results from an investigator-sponsored Phase 1b
trial of ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF)
inhibitory antibody product candidate, in combination with
nab-paclitaxel and gemcitabine in patients with previously
untreated metastatic pancreatic ductal adenocarcinoma (PDAC). The
results were presented during a poster session at the 2020 American
Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers
Symposium. A copy of the presentation, titled “Phase 1b Study of
Gemcitabine, Nab-paclitaxel, and Ficlatuzumab in Patients with
Advanced Pancreatic Cancer” (abstract 693), is available in the
Publications & Presentations section of AVEO’s website.
The study, which was based on preclinical findings demonstrating
a synergistic effect of the combination in a preclinical model of
PDAC, was designed to determine the maximum tolerated dose of
ficlatuzumab when combined with gemcitabine and nab-paclitaxel.
Secondary outcome measures included response rate and progression
free survival. A total of 24 patients were enrolled. The average
number of 28-day cycles received was 7.5 (range 1-15), with 3
patients remaining on active treatment. The combination was
associated with a promising durable response rate relative to
expectations for gemcitabine and nab-paclitaxel alone. This
included a 29% partial response (PR) rate and 92% rate of disease
control (PR + stable disease). Treatment with this regimen was
associated with significant hypoalbuminemia and edema, and
therefore a follow up safety study is under consideration of
ficlatuzumab in combination with an alternate cytotoxic
regimen.
“Pancreatic cancer remains among the most challenging diseases
to treat, owing to late diagnoses, rapid progression and early
mortality,” said Kimberly Perez, MD, Dana-Farber Cancer Institute.
“By targeting the c-MET pathway, ficlatuzumab inhibits the
Prrx1b-HGF signaling associated with pancreatic development,
pancreatitis, and carcinogenesis. These Phase 1b results show
encouraging responses that support the further study of
ficlatuzumab in pancreatic cancer.”
“Ficlatuzumab continues to emerge as a promising clinical
candidate, with these results adding to a growing body of clinical
data in acute myeloid leukemia and head and neck cancer,” said
Michael Bailey, president and chief executive officer of AVEO. “As
we continue to execute on our tivozanib Phase 3 clinical and U.S.
registration strategy and move closer to its potential
commercialization, we look forward to seeing ficlatuzumab progress
in multiple clinical studies, with the goal of determining a
pivotal strategy, assuming favorable study outcomes.”
“Ficlatuzumab continues to demonstrate the potential for major
clinical utility in areas of significant unmet need,” said Scott
Hutton, Chief Executive Officer of Biodesix. “We look forward to
continuing our diagnostic development work alongside AVEO to help
realize the full potential of this promising therapeutic
candidate.”
About Ficlatuzumab
Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte
growth factor (HGF) inhibitory antibody that binds to the HGF
ligand with high affinity and specificity to inhibit HGF/c-Met
biological activities. AVEO and Biodesix, Inc. have a worldwide
agreement to develop and commercialize ficlatuzumab. Ficlatuzumab
is currently being evaluated in squamous cell carcinoma of the head
and neck (SCCHN), metastatic pancreatic ductal cancer (PDAC), and
acute myeloid leukemia (AML).
About AVEO
AVEO Pharmaceuticals is a biopharmaceutical company seeking to
advance targeted medicines for oncology and other unmet medical
needs. The Company’s lead candidate is tivozanib, a potent,
selective, long half-life inhibitor of vascular endothelial growth
factor 1, 2 and 3 receptors, which AVEO is working to develop and
commercialize in North America as a treatment for renal cell
carcinoma (RCC), hepatocellular carcinoma (HCC) and other cancers.
Tivozanib (FOTIVDA®) is approved by the European Commission for the
treatment of adult patients with advanced RCC in the European Union
plus Norway, New Zealand, and Iceland. AVEO is leveraging or seeks
to leverage partnerships to develop and commercialize its pipeline
of products and product candidates, including tivozanib in oncology
and other indications in various geographies, and ficlatuzumab (HGF
MAb) in head and neck cancer, pancreatic cancer and acute myeloid
leukemia. AVEO’s earlier-stage pipeline includes AV-203 (anti-ErbB3
MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb) for various
oncology indications.
For more information, please visit the Company’s website at
www.aveooncology.com.
About Biodesix
Biodesix is a lung cancer diagnostic solutions company
addressing the continuum of patient care from early diagnosis of
lung nodules through late stage cancer. The company develops
diagnostic tests addressing important clinical questions by
combining simple blood draws and multi-omics with the power of
artificial intelligence. Biodesix is the first company to offer
three best-in class tests for patients with lung cancer, and
multiple pipeline tests including one with the potential to
identify patients who may benefit from immunotherapies. The
Biodesix Lung Reflex® strategy integrates the GeneStrat® and
VeriStrat® tests to support treatment decisions with results in 72
hours. The Nodify XL2™ nodule test evaluates the risk of
malignancy, enabling physicians to triage patients to the most
appropriate course of action. Biodesix also partners with the
world’s leading biotechnology and pharmaceutical companies to solve
complex diagnostic challenges. For more information about Biodesix,
please visit www.biodesix.com.
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,” “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 and tivozanib to commercialization; 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 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 commercialization of tivozanib in the United States and Europe;
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, 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; AVEO’s ability to successfully file an
NDA for tivozanib; 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; 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200127005215/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
BIODESIX: Jordona Jackson Smith for Biodesix (805) 674-7347
Jordona@jacksonbio.com
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