Site icon pharmaceutical daily

AVEO and Biodesix Announce Positive Results from Phase Ib Ficlatuzumab-Cytarabine Trial in Patients with Relapsed and Refractory AML

– Data presented during poster session at the AACR 2019 Annual
Meeting –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–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.

Contacts

AVEO:
David Pitts, Argot Partners
(212) 600-1902
aveo@argotpartners.com

Biodesix:
Kena Hudson
Kena@HudBio.com
(510)
908-0966

Exit mobile version