- Data presented during poster session at the
AACR 2019 Annual Meeting -
AVEO Oncology (NASDAQ:AVEO) and Biodesix, Inc. today announced
results from an investigator-sponsored Phase Ib expansion cohort of
ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF)
inhibitory antibody product candidate, in combination with
cytarabine in patients with relapsed and refractory acute myeloid
leukemia (AML). The results were presented in a poster session at
the American Association for Cancer Research (AACR) 2019 Annual
Meeting. The presentation, titled, “CyFi: Results from a phase Ib
expansion cohort of ficlatuzumab (Fi) combined with high-dose
cytarabine (Cy) in patients with high risk relapsed or refractory
acute myeloid leukemia (AML)” (abstract CT078/2) is available in
the Publications & Presentations section of AVEO’s website.
Elevated serum HGF level is an adverse prognostic factor
associated with worse survival in AML and other cancers.
Pre-clinical models have shown that myeloid blasts produce HGF and
that blocking the HGF/c-Met pathway sensitizes blasts to cell
death. The Phase Ib trial, which was funded by Gateway for Cancer
Research and is being conducted at the UCSF Medical Center under
the direction of Charalambos Andreadis, M.D., Associate Professor
of Clinical Medicine, Director, Clinical Research Support Office,
UCSF Helen Diller Family Comprehensive Cancer Center, was designed
to assess the safety, tolerability and preliminary efficacy of
ficlatuzumab with cytarabine in AML patients who are refractory to
first line therapy (7+3) or have relapsed within one year of
induction, a population known to have poor outcomes.
The maximally tolerated dose was 20 mg/kg of ficlatuzumab on day
1 followed by 2 g/m2 cytarabine daily on days 2-7. Of 12 patients
who received ficlatuzumab and cytarabine at the maximally tolerated
dose, one of whom was non-evaluable, 6 achieved a complete response
(CR). Of 18 patients enrolled in the study, 17 were evaluable and 9
achieved a CR. The most frequent grade 3/4 treatment emergent
adverse events observed were febrile neutropenia, LFT
abnormalities, and electrolyte disturbance. There was one death
from sepsis and multi-organ failure that was determined to be
disease related, and one patient withdrew from the study due to
grade 4 gastrointestinal bleed, determined to be likely
ficlatuzumab related. scRNA sequencing identified a TNF alpha and
IFN gamma inflammatory signature that correlated with response to
ficlatuzumab at count recovery.
“Patients with AML who are refractory to induction therapy or
relapse within one year have poor outcomes,” said Dr. Andreadis.
“Elevated serum HGF level is an adverse prognostic factor, and
these results demonstrate that the anti-HGF antibody ficlatuzumab
combined with cytarabine holds potential to affect outcomes in
patients with relapsed or refractory AML. We look forward to
potentially evaluating ficlatuzumab in larger outcome studies in
AML.”
“In addition to an attractive tolerability profile observed to
date, we also see the potential to identify biomarkers of response
using RNA sequencing. In light of these data, we believe that
further evaluation in this patient population is warranted, and we
look forward to considering additional studies with our partners at
Biodesix as a potential next step for the program,” said Michael
Bailey, president and chief executive officer of AVEO.
“We look forward to supporting ficlatuzumab’s biomarker
development initiatives with a broad set of diagnostic
technologies,” said Paul Beresford, chief business officer of
Biodesix.
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 investigator-sponsored trials in
squamous cell carcinoma of the head and neck (HNSCC), metastatic
pancreatic ductal cancer (PDAC), and acute myeloid leukemia
(AML).
About AVEO
AVEO Pharmaceuticals, Inc. (the “Company” or “AVEO”) is a
biopharmaceutical company seeking to advance targeted medicines for
oncology and other unmet medical needs. The Company is working to
develop and commercialize its lead candidate tivozanib in North
America as a treatment for RCC. The Company has sublicensed
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 also
has clinical collaborations to study tivozanib in combination with
immune checkpoint inhibitors in RCC and in hepatocellular
carcinoma. In addition, a new formulation of tivozanib is in
pre-clinical development for the treatment of age-related macular
degeneration. As part of the Company’s strategy, the Company has
also entered into partnerships to help fund the development and
commercialization of its other product candidates. Ficlatuzumab, a
HGF inhibitory antibody, is currently being tested in several
investigator sponsored studies jointly funded by the Company and
one of its development partners for the potential treatment of
HNSCC, AML, and pancreatic cancer. The Company’s partner for
AV-203, an anti-ErbB3 monoclonal antibody, is planning to initiate
clinical studies in China in 2019 in esophageal squamous cell
carcinoma and has committed to funding the development of AV-203
through proof-of-concept. The Company has recently regained the
rights to AV-380, a humanized IgG1 inhibitory monoclonal antibody
targeting growth differentiation factor 15, a divergent member of
the TGF-ß family, for the potential treatment of cancer cachexia,
and is working to initiate preclinical toxicology studies in 2019
to support the potential filing of an investigational new drug
application with the FDA. The Company is evaluating options for the
development of its preclinical AV-353 platform which targets the
Notch 3 pathway.
For more information, please visit the Company’s website at
www.aveooncology.com.
About Biodesix
Biodesix is a lung cancer diagnostic 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 non-small cell 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,
which will be commercially available in the second half of 2019,
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 develop companion diagnostics. 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
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 safety, tolerability and
efficacy of the ficlatuzumab-cytarabine combination; the potential
to identify biomarkers of response in the relapsed/refractory AML
population; and AVEO’s plans to further evaluate the
ficlatuzumab-cytarabine combination in the relapsed/refractory AML
population. 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, 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; 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 and Biodesix’s website
addresses in this press release are intended to be inactive textual
references only and not active hyperlinks.
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version on businesswire.com: https://www.businesswire.com/news/home/20190401005861/en/
AVEO:David Pitts, Argot Partners(212)
600-1902aveo@argotpartners.com
Biodesix:Kena HudsonKena@HudBio.com(510) 908-0966
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