Peregrine Pharmaceuticals Highlights Clinical Data Presentation at AACR 2017 Annual Meeting Supporting Potential of Bavituxim...
April 04 2017 - 8:05AM
-- SUNRISE Data Analysis Demonstrates
Statistically Significant Overall Survival (OS) Improvement in
Patients Receiving Bavituximab plus Docetaxel and Subsequent
Immunotherapy Compared to Placebo plus Docetaxel and Subsequent
Immunotherapy --
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 announced the presentation of results of a new
analysis of the Phase III SUNRISE trial of bavituximab in patients
with previously treated locally advanced or metastatic non-squamous
non-small cell lung cancer (NSCLC). Data demonstrated that
for patients in the study’s bavituximab plus docetaxel treatment
arm who received subsequent immunotherapy, the median overall
survival (mOS) was not reached, while mOS was 13.0 months for
patients in the study’s placebo plus docetaxel arm who received
subsequent immunotherapy [HR = 0.43; p=0.005]. These are the
first clinical results reported supporting the hypothesis that
bavituximab may modulate the tumor microenvironment to enhance the
anti-tumor activity of immunotherapy agents. Data were
presented by Peregrine scientists at the 2017 Annual Meeting of the
American Association for Cancer Research (AACR), which is being
held April 1-5, 2017 in Washington, D.C.
The presentation highlighted an analysis in
which the company evaluated the impact of subsequent immunotherapy
treatment, as well as patients’ pre-treatment interferon gamma
(IFN-γ) levels on overall survival. Overall, low peripheral
IFN-γ correlated with more favorable OS in the patients receiving
bavituximab + docetaxel and is a biomarker of interest. Data
were also analyzed by low versus high IFN-γ levels. For
patients with low pre-treatment IFN-γ levels who received
subsequent immunotherapy, those in the bavituximab plus docetaxel
arm did not reach mOS compared to mOS of 12.1 months for the
placebo plus docetaxel arm [HR = 0.24; p < 0.001].
“We are extremely encouraged by the results of
these exploratory analyses which provide further clinical rationale
for combining bavituximab and checkpoint inhibitors,” said Joseph
Shan, vice president of clinical and regulatory affairs at
Peregrine. “This will be the key focus for upcoming early phase
clinical trials, which includes a study of bavituximab and
pembrolizumab in head and neck cancer through our ongoing
collaboration with the National Comprehensive Cancer Network.”
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. PS-targeting antibodies have demonstrated an ability to
shift the functions of immune cells in tumors, resulting in
multiple signs of immune activation and anti-tumor immune
responses. Bavituximab is believed to override PS immunosuppressive
signaling by blocking the engagement of PS with its receptors and
sending an alternate immune activating signal.
Peregrine’s clinical development strategy for
bavituximab currently focuses on small, early-stage,
proof-of-concept trials evaluating the drug in combination with
other cancer treatments. This approach includes the recently
announced grants awarded by the National Comprehensive Cancer
Network (NCCN) to support three different clinical trials of
bavituximab treatment combinations. These trials will
evaluate novel bavituximab combinations in glioblastoma, head and
neck cancer, and hepatocellular carcinoma including an
immunotherapy combination. Additionally, Peregrine continues
to advance its pre-clinical collaboration with MSK with the goal of
evaluating combinations of bavituximab with checkpoint inhibitors
and other immune stimulatory agents. The intent behind this
strategy is to focus our research and development spending to
further validate bavituximab's combination potential as we seek to
advance the program though a pharmaceutical or biotechnology
partner.
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
median OS data from a clinical trial combining bavituximab with a
checkpoint inhibitor will not be consistent with the data from the
SUNRISE trial for those patients received subsequent immunotherapy
following cessation of treatment with bavituximab and docetaxel and
the risk that data from subsequent studies do not confirm that
IFN-y is a predictive biomarker for patients who are more likely to
benefit from a bavituximab containing therapeutic regimen. . 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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