Peregrine Pharmaceuticals Presents Preclinical Data Demonstrating PS-Targeting Antibodies Significantly Enhance the Anti-Tumo...
September 27 2016 - 8:05AM
-- Complete Tumor Regression Seen in 80% of
Animals Treated with Triple Combination of PS-Targeting Antibody,
Anti-PD-1 Therapy and Anti-Lag3 Therapy vs. 0% of Animals Receiving
Double Anti-PD-1/Anti-Lag3 Treatment Combination --
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 preclinical study
data demonstrating that phosphatidylserine (PS)-targeting
antibodies similar to bavituximab are able to enhance the
anti-tumor activity of multiple checkpoint targeting agents
including anti-PD-1 and anti-LAG3 therapies in a model of triple
negative breast cancer (TNBC). Data showed that eight of the
ten (80%) animals receiving the preclinical bavituximab equivalent
(ch1N11) combined with anti-PD-1 and anti-LAG3 therapies (“Triple
Combination”) experienced complete tumor regressions, whereas there
were no animals (0/10) in the anti-PD-1 and anti-LAG3 combination
treatment arm that had a complete regression.
Additional data demonstrated that the Triple
Combination featuring ch1N11 led to a 99% reduction in total tumor
volume at the interim analysis point (Day 25) across all animals as
compared to the control arm. In addition, the Triple
Combination showed a statistically significant increase in tumor
growth inhibition (TGI) as compared to the anti-PD-1 and anti-LAG3
combination treatment (99% vs. 62%; p < 0.05). Peregrine’s
Michael J. Gray, Ph.D., the study’s lead scientist, presented the
study findings at the Second CRI-CIMT-EATI-AACR International
Cancer Immunotherapy Conference September 25-28, 2016, in New York
City.
The presented study evaluated various
combinations of ch1N11, anti-PD-1 and anti-LAG3 therapy in the
well-characterized E0771 murine model of TNBC. Other key
study findings included:
- Treatment with Triple Combination therapy
(ch1N11/anti-PD-1/anti-LAG3) led to a significant increase in tumor
infiltrating lymphocytes (TILs), particularly CD8+ T cells, as
compared with anti-PD-1 and anti-LAG3 combination
treatments.
- Treatment with Triple Combination therapy
(ch1N11/anti-PD-1/anti-LAG3) resulted in a reduction in
immunosuppressive cell types, including CD4+ cells, regulatory T
cells (Tregs) and myeloid derived suppressor cells (MDSCs).
These results show that the Triple Combination therapy is capable
of significantly altering the tumor microenvironment from highly
immunosuppressive to highly immuno-stimulatory. Other treatment
combinations evaluated in the study lacked a statistically
significant reduction in immunosuppressive cells.
“These data offer compelling evidence for the
therapeutic potential of including PS-targeted therapies in
combination with multiple checkpoint inhibitors in the treatment of
TNBC. This is highlighted by the dramatic distinction in
complete tumor regression rates seen between the Triple Combination
and anti-PD-1/anti-LAG3 treatment arms, combined with the
significant difference in tumor growth inhibition percentages
witnessed for these groups,” stated Jeff T. Hutchins, Ph.D.,
Peregrine’s vice president, preclinical research. “In addition to
its impact on tumor growth, we saw very important changes in the
tumor microenvironment with the Triple Combination treatment with a
significant reduction in cell types that contribute to immune
suppression such as CD4+ cells, Tregs and MDSCs coupled with the
expansion of tumor fighting cells such as CD8+ T cells. These
data offer mechanistic evidence that highlight the manner by which
the combination of ch1N11/anti-PD-1/anti-LAG3 may be eliciting such
anti-tumor responses.”
Bavituximab is an investigational monoclonal
antibody that targets 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. Previous studies
demonstrated PS-targeting antibodies shift the functions of immune
cells in tumors, resulting in multiple signs of immune activation
and anti-tumor responses. Peregrine evaluates the preclinical
equivalent of bavituximab, ch1N11, in animal model studies to guide
clinical development.
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 by the National Comprehensive Cancer Network
(NCCN) to support three different clinical trials of bavituximab
treatment combinations. Those 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 Memorial Sloan Kettering Cancer
Center with the goal of evaluating combinations of bavituximab with
other checkpoint inhibitors and 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 the
preclinical data from the triple combination therapy will not be
duplicated in future clinical trials and the risk that the
company’s clinical development strategy will not generate clinical
data sufficiently compelling to attract a partner to advance the
program. 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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