Peregrine Pharmaceuticals Reports Top-Line and Initial Biomarker Data from Phase III SUNRISE Trial of Bavituximab in Oral Pre...
October 10 2016 - 8:05AM
-- Company Has Identified Beta-2 Glycoprotein-1
(β2GP1) as a Biomarker that Correlates with Statistically
Significant Improvement in Overall Survival for Patients Receiving
the Bavituximab Combination Compared to Chemotherapy Alone --
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a
biopharmaceutical company committed to improving patient lives by
manufacturing high quality products for biotechnology and
pharmaceutical companies and advancing its proprietary R&D
pipeline, today reported that top-line data from the Phase III
SUNRISE trial of bavituximab in patients with previously treated
locally advanced or metastatic non-squamous non-small cell lung
cancer (NSCLC) were presented in an oral presentation at the
European Society for Medical Oncology (ESMO) 2016 Congress.
The presentation included interim efficacy and safety outcomes, as
well as initial findings from the company’s ongoing biomarker
analysis of samples collected during the study. The SUNRISE Phase
III trial was discontinued earlier this year based on a
pre-specified interim analysis although patient treatment and
follow-up in the study were allowed to continue. The
pre-planned biomarker analysis has been taking place as patient
follow-up has continued and available results were evaluated as
part of the recent top-line data analysis.
The study protocol pre-specified the collection
of thousands of patient samples for exploratory analyses over a
wide range of possible biomarkers, including pre-treatment levels
of beta-2 glycoprotein-1 (β2GP1). Data presented at ESMO
demonstrated that patients with pre-treatment β2GP1 levels between
200 and 240 (representing approximately 30% of randomized patients)
achieved a statistically significant, 5.5-month improvement (13.2
months vs. 7.7 months) in median overall survival (OS) as compared
to patients in the control group with the same range of β2GP1
levels [p = 0.049; hazard ratio (HR) = 0.67]. A similar trend
was observed with pre-treatment β2GP1 levels ≥ 200 µg/mL
(representing approximately 50% of randomized patients) with 11.9
months vs. 10.1 months median OS in favor of the
bavituximab-containing group (p = 0.155; HR = 0.81). Taken
together, this strongly suggests β2GP1 levels may be useful for
identifying patients who are more likely to benefit from a
bavituximab containing therapeutic regimen. Numerous additional
biomarkers are currently being analyzed with the goal of developing
a multi-marker signature that can potentially identify patients
that are likely to receive significant clinical benefit from a
bavituximab-containing therapeutic regimen.
Top-line results reported at ESMO today were
based on a data cut-off after 70% (330/473) of the targeted OS
events had been reached and demonstrated the addition of
bavituximab to docetaxel did not result in improvement of the
study’s primary endpoint of OS in the intent-to-treat population.
Median OS for the bavituximab plus docetaxel group was 10.7 months
as compared to 10.8 months for the placebo plus docetaxel control
group (HR = 1.110; p = 0.382). Median progression free
survival (PFS) for the bavituximab-containing group was 4.1 months
compared to 3.9 months for the control group (HR = 0.97; p =
0.803). Objective response rates based on independent central
review are currently 13% and 11% (p = 0.53) for the
bavituximab-containing and control groups, respectively.
Additionally, the safety profile of the combination of bavituximab
with docetaxel was similar to placebo plus docetaxel.
“With every clinical trial we conduct, we are
constantly reminded of the difficulty involved in treating patients
with non-small cell lung cancer. This continues to prove to
be a very challenging cancer to combat and the need for effective
treatments remains high,” David R. Spigel, MD, chief scientific
officer and program director of Lung Cancer Research at the Sarah
Cannon Research Institute and one of the lead investigators in the
SUNRISE trial. “The findings with regard to β2GP1 that have
been collected as part of the ongoing SUNRISE trial data analysis
are interesting and support further investigation.”
Peregrine intends to further evaluate the role
of β2GP1 levels in response to bavituximab therapy in future
clinical trials. The company has filed a new patent
application directed to the use of this initial biomarker
discovery. Additional patient sample testing and analysis is
ongoing and may result in other biomarkers of
importance.
“We would once again like to thank all of the
patients, clinical investigators and scientists who participated in
the SUNRISE trial and have made it possible for us to continue to
collect and analyze a range of key data from the study. While
we were disappointed with the trial being discontinued earlier in
the year, we are excited by the fact that we are beginning to learn
important information from the trial through the ongoing biomarker
analysis program that will be critical in helping guide the future
clinical development of bavituximab,” said Joseph Shan, vice
president of clinical and regulatory affairs at Peregrine.
“It is encouraging that the initial biomarker analysis has
identified an important biomarker early in the process and we are
optimistic that additional biomarkers associated with improved
outcomes for bavituximab-containing treatments will be identified
as the analysis continues. We expect to be able to share the
emerging data over the coming months at scientific and medical
conferences as the more results become available.”
Mr. Shan continued, “It is not uncommon in the
cancer field for therapeutic candidates to suffer clinical trial
setbacks as researchers continue to learn more about the most
appropriate patient populations for those drugs. In this
landscape, biomarkers play an increasingly important role in
helping identify specific patient characteristics that may impact
responses to a treatment. This has been seen historically
with targeted cancer treatments, as well as more recently with
checkpoint inhibitors including PD-1 inhibitors. We look
forward to identifying the equivalent markers for bavituximab that
will help guide its clinical development.”
Bavituximab is an investigational chimeric
monoclonal antibody that targets phosphatidylserine (PS). Signals
from PS inhibit the ability of immune cells to recognize and fight
tumors. Bavituximab is believed to override PS mediated
immunosuppressive signaling by blocking the engagement of PS with
its receptors as well as by sending an alternate immune activating
signal. PS targeting antibodies have been shown to shift the
functions of immune cells in tumors, resulting in multiple signs of
immune activation and anti-tumor immune responses.
Peregrine’s clinical development strategy for
bavituximab is currently focused on small, early-stage
proof-of-concept trials evaluating the drug in combination with
other cancer treatments. The intent behind this strategy is
to control research and development costs, while continuing to
generate clinical data to further validate bavituximab's
combination potential that will be critical to bringing onboard a
partner to help advance the program.
About Peregrine Pharmaceuticals,
Inc.Peregrine Pharmaceuticals, Inc. is a biopharmaceutical
company committed to improving the lives of patients by delivering
high quality pharmaceutical products through its contract
development and manufacturing organization (CDMO) services and
through advancing and licensing its investigational immunotherapy
and related products. Peregrine's in-house CDMO services,
including cGMP manufacturing and development capabilities, are
provided through its wholly-owned subsidiary Avid Bioservices, Inc.
(www.avidbio.com), which provides development and biomanufacturing
services for both Peregrine and third-party customers. The
company is also working to evaluate its lead immunotherapy
candidate, bavituximab, in combination with immune stimulating
therapies for the treatment of various cancers, and developing its
proprietary exosome technology for the detection and monitoring of
cancer. For more information, please visit
www.peregrineinc.com.
Safe Harbor Statement:
Statements in this press release which are not purely historical,
including statements regarding Peregrine Pharmaceuticals'
intentions, hopes, beliefs, expectations, representations,
projections, plans or predictions of the future are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. The forward-looking statements involve risks
and uncertainties including, but not limited to, the risk that
further evaluation of the role of β2GP1 levels in response to
bavituximab therapy does not indicate statistically significant
improvements in overall survival correlated with β2GP1 levels for
patients, the risk that the company does not identify additional
biomarkers identifying patients most likely to respond to
bavituximab treatment, and the risk that the company is unable to
secure patent protection directed to the use of β2GP1 levels as a
biomarker. The company's actual results could differ
materially from those in any such forward-looking statements.
Factors that could cause actual results to differ materially
include, but are not limited to, uncertainties associated with
completing preclinical and clinical trials for our technologies;
the early stage of product development; the significant costs to
develop our products as all of our products are currently in
development, preclinical studies or clinical trials; obtaining
additional financing to support our operations and the development
of our products; obtaining regulatory approval for our
technologies; anticipated timing of regulatory filings and the
potential success in gaining regulatory approval and complying with
governmental regulations applicable to our business. Our business
could be affected by a number of other factors, including the risk
factors listed from time to time in our reports filed with the
Securities and Exchange Commission including, but not limited to,
our annual report on Form 10-K for the fiscal year ended April 30,
2016 as well as any updates to these risk factors filed from time
to time in the company's other filings with the Securities and
Exchange Commission. The company cautions investors not to place
undue reliance on the forward-looking statements contained in this
press release. Peregrine Pharmaceuticals, Inc. disclaims any
obligation, and does not undertake to update or revise any
forward-looking statements in this press release.
Contacts:
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
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