CAMBRIDGE, Mass. & CHICAGO--(BUSINESS WIRE)--May 31, 2014--
AVEO Oncology (NASDAQ:AVEO) today announced the presentation of results
from a first-in-human Phase 1 study of AV-203, AVEO’s ErbB3 (HER3)
inhibitory antibody candidate. Among the results, the study established
a recommended Phase 2 dose of AV-203, demonstrated good tolerability and
promising early signs of activity, and reached the maximum planned dose
of AV-203 monotherapy. The results were presented in a poster, entitled
“First-in-human Phase 1 dose-escalation study of AV-203, a monoclonal
antibody against ErbB3 in patients with metastatic or advanced solid
tumors” (Abstract #11113, Poster #395, S Hall A2), at the Tumor Biology
General Poster Session of the American Society of Clinical Oncology 2014
Annual Meeting, taking place May 30 - June 3, 2014, in Chicago.
“ErbB3 is a promising target for the treatment of a wide range of
cancers, as it is both an important tumor survival pathway and may serve
as a resistance mechanism for widely-used therapies targeting EGFR and
HER2, among others,” stated Dr. John Sarantopoulos of the Institute for
Drug Development, Cancer Therapy and Research Center at the University
of Texas Health Science Center at San Antonio. “The results we see in
this first-in-human study of AV-203 demonstrate good tolerability and an
early signal of activity consistent with preclinical data showing the
potential for neuregulin-1, the only known ligand for ErbB3, to serve as
a biomarker predictive of AV-203 anti-tumor activity. These data provide
a rationale for further investigation of AV-203 as novel anticancer
therapy.”
A total of 22 patients were evaluated in the Phase 1, open-label,
dose-escalation study. Objectives included safety, tolerability, dose
limiting toxicities (DLT), maximum tolerated dose and/or recommended
phase 2 dose in patients with advanced solid tumors. Evaluation of NRG-1
as a predictive biomarker was an exploratory objective. Patients
received 2, 5, 9, 14, or 20 mg/kg of AV-203 intravenously once every 2
weeks (2 times per 28 day cycle). AV-203 was found to be generally safe
and well-tolerated, with diarrhea and decreased appetite as the most
common treatment-emergent and treatment-related adverse events (all
grade). Across all doses of AV-203, there was a single DLT that occurred
in an elderly patient at the lowest dose cohort (inability to tolerate
study drug). The recommended Phase 2 dose was established at 20mg/kg
intravenously every 2 weeks. No anti-drug antibodies were detected, and
pharmacokinetic results indicated a dose-proportional increase in levels
of AV-203.
Among 22 evaluable patients, stable disease was the best response for 8
patients, including a partial response lasting 6 cycles and a long-term
stable disease lasting at least 22 cycles (>98 weeks), resulting in a
disease control rate of 36%. Neuregulin-1 (NRG-1, also known as
heregulin or HRG) status, which AVEO’s preclinical studies suggest is
predictive of AV-203 anti-tumor activity, was analyzed via RT-PCR. Of 14
subjects analyzed for NRG-1 expression, two patients were NRG-1
positive, one of whom, a patient with squamous non–small cell lung
cancer, achieved a partial response. CLIA (Clinical Laboratory
Improvements Amendment) validation is complete for an NRG-1 biomarker
assay for potential use in patient selection in future clinical trials.
In March 2014, AVEO announced that it completed negotiations to
reacquire worldwide rights for AV-203 from ex-US licensor Biogen Idec, a
company which had previously announced plans to shift its therapeutic
focus away from oncology.
About AV-203
AV-203 is a potent and selective ErbB3 (HER3) inhibitory antibody
candidate designed to inhibit both ligand-dependent and
ligand-independent ErbB3 signaling. ErbB3 is a receptor that is
typically expressed in many human cancers, and AV-203 has demonstrated
preclinical activity in a number of different tumor models including
breast, head and neck, lung, ovarian and pancreatic cancers. Preclinical
data also suggest that Neuregulin-1 (NRG-1) levels predict AV-203
anti-tumor activity. NRG-1, also known as heregulin (HRG), is the only
known ligand of ErbB3, and the most potent activator of the ErbB3/HER2
complex.
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™
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.
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 potential for NRG-1 to serve as a biomarker
predictive of AV-203 anti-tumor activity; the use of ErbB3 as a target
for cancer treatment and ErbB3’s tendency to serve as a resistance
mechanism; and plans and prospects for further investigation of AV-203
as an anti-cancer therapy, including its potential safety and efficacy
in humans. 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
strategy and enter into and maintain new strategic partnerships and
collaboration agreements; 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; and those risks discussed in the section titled “Risk Factors”
included in AVEO’s Quarterly Report on Form 10-Q filed with the SEC on
May 7, 2014 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.

Source: AVEO Oncology
Investors:
AVEO Oncology
Rob Kloppenburg, 617-930-5595
or
Media
and Investors:
Argot Partners
David Pitts, 212-600-1902