AVEO Oncology Announces Clinical Updates to Tivozanib and Ficlatuzumab Programs
December 07 2017 - 7:00AM
Business Wire
- Enrollment complete in Phase 2 portion of
Phase 1/2 TiNivo trial; Next data presentation expected at 2018
Genitourinary Cancers Symposium in February 2018-
- Investigator-sponsored studies of
ficlatuzumab initiated in HNSCC and Pancreatic Cancer -
AVEO Oncology (NASDAQ:AVEO) today announced clinical updates for
two of its oncology programs: FOTIVDA® (tivozanib), the Company’s
potent, selective, long half-life inhibitor of all three vascular
endothelial growth factor (VEGF) receptors, and ficlatuzumab, the
Company’s humanized IgG1 antibody that binds to the hepatocyte
growth factor (HGF) ligand with high affinity and specificity to
inhibit the biological activities of the HGF/c-Met pathway.
“We continue to build strong momentum in our oncology programs,
including progress with our lead program, tivozanib, and the
advancement of our other oncology programs, including ficlatuzumab
and AV-203,” said Michael Bailey, president and chief executive
officer of AVEO. “With approval of tivozanib and commercial sales
underway in Europe, we are squarely focused on the next two pillars
of our tivozanib strategy: the potential for U.S. registration and
additional immunotherapy combination studies. As these strategies
unfold, 2018 is expected to be another transformative year, with
anticipated top-line results in the TIVO-3 study of tivozanib in
third line advanced renal cell carcinoma (RCC), as well as
development of our earlier-stage programs, including the TiNivo
study of tivozanib in combination with Opdivo®, and the initiation
of two ficlatuzumab investigator-sponsored studies.”
Tivozanib Updates
- Enrollment Complete in Phase 2
Portion of Phase 1/2 TiNivo Trial in Advanced RCC. AVEO
announced today that enrollment of 21 patients is now complete,
with one patient remaining in screening, in the Phase 2 portion of
the TiNivo study, a Phase 1/2 multicenter trial of tivozanib in
combination with Bristol-Myers Squibb’s OPDIVO® (nivolumab), an
immune checkpoint, or PD-1, inhibitor, for the treatment of
advanced RCC. In the Phase 1 dose escalation portion of the trial,
tivozanib was administered in two escalating dose cohorts, 1.0 and
1.5 mg daily, in combination with nivolumab at 240 mg every 2 weeks
(n=6).Phase 1 data from the study, which were presented at the 16th
International Kidney Cancer Symposium, demonstrated that the
combination of Opdivo and tivozanib was well tolerated up to the
full dose and schedule of single agent tivozanib (1.5 mg daily),
with no dose limiting toxicities. The most common adverse events
(any grade) were hypertension, asthenia and decreased appetite. No
grade 4 adverse events were reported. Two grade 3 events were
reported beyond cycle 1 (stomatitis and increased ALT), which did
not lead to study discontinuation and were managed concurrently.
Best response at the time of presentation included a 67% (4/6)
partial response (PR) rate and a 100% disease control rate (4
confirmed PR + 2 stable disease, 1 of which was unconfirmed).
Additional results from the Phase 1 portion of the trial and
initial results from the Phase 2 portion are expected to be
presented at scientific meetings in the first half of 2018,
including at the 2018 Genitourinary Cancers Symposium taking place
February 8-10, 2018, and co-sponsored by the American Society of
Clinical Oncology.
Ficlatuzumab Updates
- Phase 2 Study of Ficlatuzumab in
Combination with Cetuximab in HNSCC Initiated. The Company
announced today the initiation of an investigator-sponsored
randomized, multicenter Phase 2 trial of ficlatuzumab and cetuximab
(ERBITUX®), an EGFR-targeted antibody, in patients with
cetuximab-resistant, metastatic head and neck squamous cell
carcinoma (HNSCC). AVEO is partnered with Biodesix, Inc. on the
developments of ficlatuzumab. The study will seek to confirm
findings from a Phase 1 study where the addition of ficlatuzumab to
cetuximab resulted in a disease control rate of 67%, and prolonged
progression free and overall survival compared to historical
controls, in addition to being well tolerated. This Phase 2
multi-center study, which 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, is expected to enroll
approximately 60 patients randomized to receive either ficlatuzumab
alone or ficlatuzumab and cetuximab.
- Phase 1b Study of Ficlatuzumab in
Combination with Gemcitabine and Nab-paclitaxel in Pancreatic
Cancer Initiated. The Company announced today the initiation of
an investigator-sponsored Phase 1b study to test the safety and
tolerability of ficlatuzumab when combined with Nab-paclitaxel and
Gemcitabine in previously untreated metastatic pancreatic ductal
cancer (PDAC). The goal of the study, which is based on preclinical
findings demonstrating a synergistic effect of these drugs in a
preclinical model of PDAC, is designed to determine maximum
tolerated dose of ficlatuzumab when combined with gemcitabine and
nab-paclitaxel. Secondary outcome measures include response rate
and progression free survival. The study, which is being conducted
under the direction of Kimberly Perez, M.D. at the Dana-Farber
Cancer Institute, is expected to enroll approximately 30
patients.
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Hakko Kirin and approved for the treatment of
adult patients with advanced renal cell carcinoma in the European
Union plus Norway and Iceland. It is a potent, selective and long
half-life inhibitor of all three VEGF receptors and is designed to
optimize VEGF blockade while minimizing off-target toxicities,
potentially resulting in improved efficacy and minimal dose
modifications. Tivozanib has been investigated in several tumors
types, including renal cell, colorectal and breast cancers.
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. currently divide all
worldwide development costs for ficlatuzumab and are seeking a
commercialization partner. Ficlatuzumab is currently being
evaluated in investigator-sponsored trials in squamous cell
carcinoma of the head and neck (HNSCC) and acute myeloid leukemia
(AML).
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to
advancing a broad portfolio of targeted therapeutics for oncology
and other areas of unmet medical need. The Company is focused on
seeking to develop and commercialize its lead candidate tivozanib,
a potent, selective, long half-life inhibitor of vascular
endothelial growth factor 1, 2 and 3 receptors, in North America as
a treatment for renal cell carcinoma and other cancers. AVEO is
leveraging multiple partnerships aimed at developing and
commercializing tivozanib in oncology indications outside of North
America, and at progressing its pipeline of novel therapeutic
candidates in cancer and cachexia (wasting syndrome). Tivozanib
(FOTIVDA®) is approved by the European Commission for the treatment
of adult patients with advanced renal cell carcinoma (RCC) in the
European Union plus Norway and Iceland. For more information,
please visit the company’s website at www.aveooncology.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: clinical, regulatory and commercial plans
of AVEO and its partner EUSA Pharma with respect to tivozanib
(FOTIVDA®); the expected timeline for reporting data from TIVO-3
and TiNivo; the role and expected benefits of tivozanib and other
TKIs on a stand-alone basis, or in combination with or following
immunotherapy; the expected benefits of ficlatuzumab alone or in
combination; the value of AVEO's partnerships in advancing its
pipeline; and AVEO’s strategy, prospects, plans and objectives,
including as they pertain specifically to tivozanib. 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 to enter into and maintain its third
party collaboration agreements, and its ability, and the ability of
its licensees and other partners, to achieve development and
commercialization objectives under these arrangements; AVEO’s
ability, and the ability of its licensees, to demonstrate to the
satisfaction of applicable regulatory agencies the safety, efficacy
and clinically meaningful benefit of AVEO’s product candidates,
including tivozanib. AVEO faces other risks relating to its
business as well, including risks relating to its ability to
successfully enroll and complete clinical trials, including the
TIVO-3 and TiNivo studies; AVEO’s ability to achieve and maintain
compliance with all 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 and technologies; developments, expenses and outcomes
related to AVEO’s ongoing shareholder litigation; 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 section titled “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations—Liquidity and Capital
Resources” included in AVEO’s Annual Report on Form 10-K for the
year ended December 31, 2016, its quarterly reports on Form 10-Q
and in other filings that AVEO may make with the SEC in the future.
The forward-looking statements in this press release represent
AVEO’s views as of the date of this press release. AVEO anticipates
that 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171207005240/en/
Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
AVEO Pharmaceuticals (NASDAQ:AVEO)
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