AVEO and Biodesix Partner to Co-Develop and Commercialize Ficlatuzumab with a Companion Diagnostic for Treatment of NSCLC

  AVEO and Biodesix Partner to Co-Develop and Commercialize Ficlatuzumab with
  a Companion Diagnostic for Treatment of NSCLC

                   Biodesix to Fund Proof of Concept Study

Business Wire

CAMBRIDGE, Mass. & BOULDER, Colo. -- April 10, 2014

AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. today announced that they have
entered into a worldwide agreement to develop and commercialize AVEO’s
hepatocyte growth factor (HGF) inhibitory antibody ficlatuzumab, with a
Biodesix^® companion diagnostic test. This agreement and the clinical
development program will leverage VeriStrat^®, a serum protein test that is
commercially available to help physicians guide treatment decisions for
patients with advanced non-small cell lung cancer (NSCLC). VeriStrat will be
used as the selection assay to identify NSCLC patients most likely to benefit
from ficlatuzumab.

An exploratory analysis from AVEO’s Phase 2 study in first-line NSCLC
suggested that VeriStrat was prognostic for outcome in the epidermal growth
factor receptor (EGFR) tyrosine-kinase inhibitor (TKI)-treated patients and
predicted differential treatment benefit for the combination of ficlatuzumab
plus TKI over TKI alone. The predictive effect was observed in both
progression-free survival and overall survival endpoints.

Under the terms of the agreement, AVEO will conduct a proof of concept study
of ficlatuzumab in combination with erlotinib in advanced NSCLC patients
selected using the VeriStrat test. Biodesix will fund up to $15 million of the
cost of the study. The companies expect to initiate this clinical study later
this year. Any additional development, regulatory and commercial costs for
ficlatuzumab beyond the proof of concept study will be shared equally as will
any potential profits. Subject to regulatory approval, AVEO will lead
worldwide commercialization of ficlatuzumab. Biodesix will be responsible for
all development, including FDA engagement activities, sales and marketing
costs for VeriStrat, and will retain total revenues for sales of VeriStrat.

"We are pleased to initiate this collaboration with AVEO," said David Brunel,
chief executive officer of Biodesix. "Ficlatuzumab is targeting an oncogenic
pathway that we believe may be important in certain patient subsets. By
leveraging our multiplexed platform and advanced analytics, we hope to
identify those patients who gain substantial benefit from ficlatuzumab. We
believe our initial work with AVEO is very encouraging.”

"This agreement accomplishes a key strategic objective of advancing our
pipeline assets through external collaborations and funding," stated Tuan
Ha-Ngoc, president and chief executive officer of AVEO. “The exploratory
analysis suggests that Biodesix’ novel diagnostic test may help define patient
populations that can benefit from treatment with ficlatuzumab. We believe this
type of innovative partnership between a therapeutic and a molecular
diagnostic company is important to advancing personalized medicine.”

About Ficlatuzumab

Ficlatuzumab is a humanized IgG1κ antibody that binds to the HGF ligand with
high affinity and specificity to inhibit the biological activities of the
HGF/c-Met pathway. Studies have demonstrated that ficlatuzumab is well
tolerated as a single agent as well as in combination with EGFR TKIs.

About the HGF/c-Met Pathway

HGF is the sole ligand that binds to and activates a receptor called c-Met.
Activation of the HGF/c-Met pathway is believed to be important in normal
processes in embryonic development and wound healing, but its dysregulation is
believed to play a role in cancer development, metastasis and drug resistance.
HGF/c-Met has also been shown to be one of the most potent drivers of tumor
growth in AVEO’s Human Response Platform™.

HGF/c-Met over-expression is observed in many solid tumors including breast,
colorectal, gastric, head and neck, lung and prostate, as well as hematologic
malignancies. Additionally, c-Met and EGFR are frequently co-amplified and
co-expressed in a variety of tumor types; HGF/c-Met pathway up-regulation can
render resistance to EGFR-targeted therapies, and vice-versa. HGF has also
been shown to be one of the most potent growth factors that can drive
resistance to a panel of anti-cancer therapies.

About VeriStrat

VeriStrat is a multivariate, blood-based, protein test currently available to
help physicians guide treatment decisions for patients with advanced non-small
cell lung cancer. The test identifies patients who are likely to have good or
poor outcomes after treatment with either epidermal growth factor receptor
tyrosine kinase inhibitor (EGFR-TKI) therapy such as erlotinib or with
chemotherapy. VeriStrat is based on Biodesix’ proprietary proteomics platform
which enables the discovery of multivariate classifiers that characterize a
patient’s condition or likely outcome in response to therapy.
www.VeriStratSupport.com

About AVEO

AVEO Oncology (NASDAQ: AVEO) is a biopharmaceutical company committed to
discovering and developing targeted therapies designed to provide substantial
impact in the lives of people with cancer by addressing unmet medical needs.
AVEO’s proprietary Human Response Platform^TM provides the company unique
insights into cancer and related disease biology and is being leveraged in the
discovery and clinical development of its therapeutic candidates. For more
information, please visit the company’s website at www.aveooncology.com.

About Biodesix

Biodesix is a molecular diagnostics company advancing the development of
innovative products for personalizing medicine. The company provides
physicians with diagnostic tests for earlier disease detection, more accurate
diagnosis, disease monitoring and better therapeutic guidance, which may lead
to improved patient outcomes. Biodesix discovers, develops and commercializes
multivariate protein diagnostics based on their proprietary mass
spectrometry-based discovery platform. In addition to developing novel
diagnostics independently, the company also partners with biotechnology and
pharmaceutical companies to develop companion diagnostics to improve utility
of therapeutic agents. For more information about Biodesix, please visit
www.Biodesix.com.

Forward-Looking Statements

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 AVEO’s plans to initiate a proof of concept study of
ficlatuzumab, the ability of VeriStrat to identify patients who may gain
benefit from ficlatuzumab, and the advancement of AVEO’s pipeline assets,
including ficlatuzumab. 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 execute on its business plan and re-align
its resources behind key development opportunities; AVEO’s ability to
successfully enroll and complete clinical trials and preclinical studies of
its product candidates; AVEO’s ability to demonstrate to the satisfaction of
the FDA, or equivalent foreign regulatory agencies, the safety, efficacy and
clinically meaningful benefit of its product candidates; 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 and expenses related to AVEO’s ongoing
shareholder litigation and SEC inquiry; AVEO’s ability to raise the
substantial additional funds required to achieve its goals; adverse general
economic and industry conditions; competitive factors; AVEO’s ability to
maintain its strategic partnerships and relationships, such as the
collaboration with Biodesix described in this press release; and those risks
discussed in the section titled “Risk Factors” included in AVEO’s most recent
Annual Report on Form 10-K and in its other filings with the SEC. 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 will cause its views to change. However, 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 subsequent to the date of this press release.

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Contact:

AVEO Contacts
AVEO Investor Relations:
617-299-5810
or
Media:
Pure Communications
Dan Budwick, 973-271-6085
or
Biodesix Contacts
Kena Hudson or Kelly Quigley, 510-908-0966
Biodesix@Chempetitive.com
 
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