AVEO Oncology & Biodesix Announce Initiation of the CyFi-2 Study, a Phase 2 Randomized Study of Ficlatuzumab in Combination w...
November 07 2019 - 7:00AM
Business Wire
AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. today announced
the initiation of the CyFi-2 study, a randomized Phase 2 clinical
study evaluating ficlatuzumab, AVEO’s potent hepatocyte growth
factor (HGF) inhibitory antibody product candidate, in combination
with high-dose cytarabine vs. high-dose cytarabine alone in
patients with relapsed and refractory acute myeloid leukemia
(AML).
AVEO will sponsor the CyFi-2 study, which is expected to enroll
up to a total of 60 patients with AML who failed induction
chemotherapy or who achieved a complete response, but relapsed
within one year. Patients will be randomized 1:1 to receive either
ficlatuzumab in combination with cytarabine or cytarabine alone at
the doses and schedules determined in the Phase 1b/2 single-arm
CyFi-1 study. CyFi-2’s primary endpoint is complete response rate,
with secondary endpoints including safety, disease-free survival,
and overall survival. The CyFi-2 study is being conducted as part
of the companies’ worldwide partnership to develop and
commercialize ficlatuzumab. Under the terms of this agreement, AVEO
and Biodesix equally share all development costs.
“Supported by promising Phase 1b/2 results from the CyFi-1
study, which showed a 50% complete response rate in primary
refractory AML patients (n=18) and an acceptable tolerability
profile, the ficlatuzumab-cytarabine combination has the potential
to improve outcomes in this historically difficult to treat
population,” said Michael Bailey, president and chief executive
officer of AVEO. “The CyFi-2 study, along with our ongoing
randomized Phase 2 study in head and neck cancer, provide two
opportunities to potentially pursue registration strategies for
ficlatuzumab, assuming favorable study outcomes.”
AVEO’s portion of the costs for both the CyFi-2 study and the
recently initiated Phase 1b/2 hepatocellular carcinoma study of
FOTIVDA® (tivozanib) in combination with AstraZeneca’s IMFINZI®
(durvalumab) is included in the company’s current cash
guidance.
“Ficlatuzumab targets an important pathway which we believe has
major clinical significance. We look forward to working with AVEO
to enable ficlatuzumab to realize its full potential,” said David
Brunel, chief executive officer of Biodesix. “At Biodesix, we are
committed to supporting biomarker development initiatives to
further identify patients who may benefit most from promising
therapies.”
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 AVEO’s plans with respect to advancement of the CyFi-2
study; 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 efficacy, safety, and
tolerability of tivozanib, as a single agent and in combination
with other therapies in several indications, such as RCC and HCC;
expected costs of AVEO’s clinical studies; AVEO’s cash runway;
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191107005226/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
Biodesix: Kena Hudson Kena@HudBio.com (510) 908-0966
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