Preclinical Data Presented at AACR Demonstrate Synergistic Anti-Tumor Effects of Peregrine Pharmaceuticals' Phosphatidylserin...
April 21 2015 - 8:00AM
- Combination Treatment Reduces Tumor Immune
System Blockade and Enhances Tumor Specific Immune Responses -
- Studies Reveal Significant Increases in
Tumor-Infiltrating CD8+ T Cells and Immune-Activating Cytokines
while Decreasing Tumor-Promoting Macrophages and Myeloid Cells
-
Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP) today
announced the presentation of data from preclinical studies
demonstrating the combination of phosphatidylserine (PS) blockade
with anti-PD-1 or anti-CTLA-4 immune checkpoint inhibitors promoted
strong, localized and enhanced efficacy in models of melanoma and
breast cancer. These data were presented at the 106th Annual
Meeting of the American Association for Cancer Research (AACR)
being held in Philadelphia, Pennsylvania from April 18-22, 2015.
Peregrine's lead PS-blocking antibody, bavituximab, is currently
being evaluated in second-line non-small cell lung cancer (NSCLC)
in a Phase III clinical trial named Sunrise.
"The data presented this week at AACR showed in much greater
detail the collective ability of PS and PD-1 blockade to change the
immune response in melanoma and breast cancer models," said Jeff T.
Hutchins, Ph.D., vice president of preclinical research at
Peregrine. "These data showed that blocking PS resulted in a
decrease in immune-blocking cell types such as myeloid-derived
suppressor cells and M2 macrophages while increasing the number of
activated T-cells that are able to specifically recognize and kill
tumor cells which set the stage for anti-PD-1 therapy that keeps
the immune response going. The result were synergistic anti-tumor
effects in established melanoma and breast cancers. The consistency
of the data generated from pre-clinical experiments, and, more
recently, in clinical translational studies is impressive. When
taken together with the additional lung cancer translational data
presented Sunday, we are obtaining a clearer picture as to the
potential of bavituximab in different immuno-oncology combinations.
We look forward to presenting additional supporting data over the
coming months."
In a poster titled: "Antibody-mediated phosphatidylserine
blockade significantly enhances the efficacy of immune checkpoint
blockades in K1735 and B16 mouse melanoma models," researchers from
Peregrine, UT Southwestern Medical Center and the University of
California at Irvine presented data assessing the antitumor effect
of the combination of PS blockade and anti-CTLA-4 or anti-PD-1
antibodies in preclinical models of melanoma. Both combinations
showed significantly superior tumor growth inhibition over single
treatment, with many subjects achieving complete tumor regressions.
The combination treatment showed significantly greater total and
functional tumor-infiltrating CD8+ T, more IL-2- and interferon
gamma (IFNγ)-producing splenic T cells, and lower number of splenic
myeloid derived suppressor cells myeloid-derived suppressor cells
(MDSCs) than did single treatment. In addition, the ratio of M2 to
M1 macrophages in the tumor was significantly lower in the
combination treatment than that in single treatment. Finally, no
toxicity was observed in any of the treatment groups following
multiple treatment doses.
In a poster titled: "Targeting of phosphatidylserine by
monoclonal antibodies enhances the activity of immune checkpoint
inhibitors in breast tumors," Peregrine researchers presented data
demonstrating that PS blockade enhances the anti-tumor activity of
combination therapies including anti-PD-1 antibodies in an immune
competent model of breast cancer. Tumor growth inhibition
correlates with statistically significant increases in the
infiltration of CD8+ T cells and a reduction of myeloid-derived
suppressor cells (MDSCs). The combination of these mechanisms
promotes strong and localized anti-tumor responses without the
side-effects of systemic immune activation.
Copies of these presentations can be found on the front page of
Peregrine's website at www.peregrineinc.com.
About Bavituximab: A Targeted Investigational Immunotherapy
Scientific research has shown that tumors evade immune detection
due partly to the expression of phosphatidylserine, or PS, a highly
immunosuppressive molecule. Peregrine's immuno-oncology development
program has developed bavituximab, an investigational monoclonal
antibody that targets and binds to PS, blocking its
immunosuppressive effects while activating tumor fighting immune
cells, thus enabling the immune system with the ability to better
recognize and fight cancer. Bavituximab's immune-stimulatory
mechanism-of-action data is the subject of a manuscript published
in the October 2013 issue of the American Association for Cancer
Research (AACR) peer-reviewed journal, Cancer Immunology Research.
Bavituximab is currently being evaluated in several solid tumor
indications, including non-small cell lung cancer (the SUNRISE
Phase III trial), breast cancer, liver cancer, rectal cancer and
advanced melanoma. In January 2014, bavituximab received Fast Track
designation by the U.S. Food and Drug Administration (FDA) for the
potential second-line treatment of patients with non-small cell
lung cancer.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company
with a pipeline of novel drug candidates in clinical trials for the
treatment and diagnosis of cancer. The company's lead immunotherapy
candidate, bavituximab, is in Phase III development for the
treatment of second-line non-small lung cancer (the "SUNRISE
trial") along with several investigator-sponsored trials evaluating
other treatment combinations and additional oncology indications.
The company is also advancing a molecular imaging agent,
124I-PGN650, in an exploratory clinical trial for the imaging of
multiple solid tumor types. Peregrine also has in-house cGMP
manufacturing capabilities through its wholly-owned subsidiary Avid
Bioservices, Inc. (www.avidbio.com), which provides development and
biomanufacturing services for both Peregrine and third-party
customers. 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 data from pre-clinical studies may not
correlate with the results from human clinical studies. It is
important to note that 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,
2014 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.
CONTACT: Christopher Keenan
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
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