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|AVEO Oncology Announces Strategic Restructuring|
AVEO to Host Conference Call
“As a result of the recent ODAC meeting, we believe that it is likely
that tivozanib will not receive
“The company intends to focus its R&D efforts on areas in oncology where
the unique insights derived from AVEO’s proprietary Human Response
Platform™ will allow the development of targeted agents with the
potential to provide substantial clinical benefit for specific
biomarker-defined patient populations that could enable a clear
regulatory pathway to approval,” said
AVEO and Astellas are continuing the BATON Phase 2 clinical trials of tivozanib in breast and colorectal cancer. The BATON-CRC study of tivozanib in patients with colorectal cancer completed patient enrollment earlier this year and results are expected in 2014. The BATON-BC study of tivozanib in triple negative breast cancer is currently enrolling patients and data results are expected in late 2014 or early 2015. Both of these trials incorporate pre-specified biomarker analyses.
AVEO intends to continue the development of AV-203, our clinical-stage ERBB3 (HER3) inhibitory antibody candidate, currently in Phase 1 with expansion cohorts in specific biomarker-defined patient populations. ERBB3 is believed to be an important biologic pathway for multiple solid tumors.
As previously announced, the company intends to focus its efforts on further ficlatuzumab development through external collaborations at this time. Ficlatuzumab is a potent hepatocyte growth factor (HGF) inhibitory antibody that blocks the HGF/c-Met pathway by binding to the HGF ligand with high affinity and specificity. Recently presented industry data have demonstrated that inhibition of this pathway can improve clinical outcomes in a variety of tumor types.
Restructuring and Reorganization
AVEO’s strategic restructuring will eliminate approximately 140 positions, or 62% of AVEO’s workforce, across the company.
“This restructuring is designed to preserve financial resources in order to support the development of AVEO’s products and pipeline,” said Mr. Ha-Ngoc. “These were very difficult decisions that were undertaken only after careful consideration. I would like to personally express my deep appreciation to the very talented and dedicated employees impacted by the restructuring for their tremendous contributions to AVEO.”
Separately, Elan Ezickson, executive vice president and chief operating
officer of AVEO, has informed the company that after a transition
period, he will resign effective
“I would like to express my gratitude to Elan for his extraordinary service to the company over the past decade,” said Mr. Ha-Ngoc. “Elan was instrumental in the growth of the company, including his key role in supporting our financing activities over the last ten years and more recently in preparing the company for the anticipated commercialization of tivozanib. His business development and licensing activities have supported the development of our pipeline of products and he led the build out of key functions in the company including medical affairs, technical operations and program management. We wish him the best in his next opportunity.”
Updated Financial Guidance
AVEO ended the first quarter of 2013 with
The AVEO management team will host a conference call
A webcast of the conference call can also be accessed by visiting the investors section of the AVEO website at investor.aveooncology.com. A replay of the webcast will be archived on the company’s website for two weeks following the call.
Tivozanib is an oral, once-daily, investigational vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor for which results from a Phase 3 clinical study in advanced RCC have been reported, and is being evaluated in other tumors.
AV-203 is an ERBB3 inhibitory antibody developed through AVEO’s Human Response Platform™. AV-203 is currently being investigated in a Phase 1 clinical trial to evaluate safety and preliminary efficacy, as well as exploratory biomarkers, in patients with advanced solid tumors.
AV-203 selectively targets the receptor ERBB3, a new and promising strategy for treating cancer, both for direct anti-tumor activity and for prevention of treatment resistance. ERBB3 belongs to a family of four proteins that also includes the EGFR (HER1) and HER2 receptors, and is a potent stimulator of cancer growth and survival.
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.
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 facts, contained in this press release are
forward-looking statements. The words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,”
“could,” “should,” “seek,” 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 design and implementation of the company’s
planned restructuring and the anticipated benefits of such
restructuring, including with respect to the expected extension of the
company’s cash runway; AVEO’s estimates with respect to its year-end
cash position, the period in which such cash will be available to fund
its operations, realized cost reductions over the next two years, and
estimated restructuring charges; AVEO’s plans to further the development
of tivozanib in colorectal and breast cancer, advance the development of
AV-203 and continue to pursue partners for ficlatuzumab; the potential
to provide clinical benefit for biomarker-defined patient populations
and enable a clear regulatory pathway to approval; AVEO’s expectations
regarding the timing of ongoing and future trials and the availability
of data from such trials; and AVEO’s plans to leverage its Human
Response Platform. 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 successfully implement
and manage its restructuring and obtain the benefits it expects to
derive from the reduction in its programs and workforce; AVEO’s ability
to demonstrate in subsequent trials any safety and efficacy it
demonstrated in earlier trials of tivozanib; ongoing regulatory
requirements with respect to the approval of tivozanib, including the
Source: AVEO Oncology