Data Presented at AACR Support Potential of Peregrine's
PS-Targeting Immunotherapy Bavituximab to Enhance Anti-Tumor and
Immune-Stimulating Effects of Anti-CTLA-4 and Anti-PD-1 Treatments
in Models of Melanoma and Colon Cancer
Combination Treatment With Upstream PS Checkpoint Inhibitor and
Downstream CTLA-4 or PD-1 Inhibitors Provides Superior Protection
Against Tumor Re-Challenge; Data Presented Show Significant
Increases in Functional Tumor Specific T Cells and Increases in
Inflammatory Cytokines Following PS and PD1 Inhibitor Combination
Therapy
TUSTIN, CA--(Marketwired - Apr 9, 2014) - Peregrine
Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), today
announced data from studies validating the immune-stimulatory
mechanism of action of bavituximab and demonstrating that the
combination of a preclinical phosphatidylserine (PS)-targeting
antibody with the immune checkpoint inhibitors anti-CTLA-4 or
anti-PD-1 antibodies yielded superior anti-tumor immune responses
in animal models of melanoma and colon cancer compared to
anti-CTLA-4 and PD-1 antibodies alone. These data were presented
yesterday and today as a late-breaking poster presentation and a
poster presentation, respectively at the 105th Annual Meeting of
the American Association for Cancer Research (AACR) being held in
San Diego, California from April 5-9, 2014. Bavituximab is an
investigational immunotherapy currently being evaluated in
second-line, non-small cell lung cancer (NSCLC) as part of the
SUNRISE pivotal Phase III clinical trial.
"Data from these combination studies are compelling as they
provide further evidence that support the immune-stimulatory
effects of bavituximab in reducing the prevalence of key
immunosuppressive checkpoints in the tumor environment, reducing
tumor-suppressive factors, reducing immune suppressor cells and
providing increased tumor-specific immunity," said Jeff T.
Hutchins, Ph.D., vice president of preclinical research at
Peregrine. "These data also show that when combined with downstream
immune checkpoint inhibitors such as anti-CTLA-4 and anti-PD-1, PS
targeting mediates an improved protective tumor-specific immunity
following tumor rechallenge. While these new downstream checkpoint
inhibitors have been shown to strengthen the tumor-killing activity
of T-cells and thus extend survival in some patients, there remains
a need to increase the number of responders that mount anti-tumor
T-cell responses in order to maximize the effects of these
downstream checkpoint inhibitors. We believe a PS-targeting
antibody, such as bavituximab, plays a key role in reducing tumor
suppression and driving a more inclusive immune-mediated response.
Insights from these data will influence our future clinical
development plans including the soon to be opened
investigator-sponsored trial assessing the potential of bavituximab
and an anti-CTLA-4 antibody in patients with advanced
melanoma."
In a poster titled: "Targeting of Phosphatidylserine by
Monoclonal Antibodies Enhances Activity of Immune Checkpoint
Inhibitors in Tumors," scientists from Peregrine Pharmaceuticals,
led by Bruce Freimark, Ph.D., director of pre-clinical research
oncology, reported that animals treated with the PS-targeting
antibody ch1N11, the preclinical equivalent to bavituximab, in
combination with anti-CTLA-4 or anti-PD-1 in melanoma and colon
cancer tumor models demonstrated greater delayed tumor growth and
suppression than anti-CTLA-4 or anti-PD-1 alone. Results also
showed that the combination with anti-CTLA-4 reduced M2 macrophages
in the melanoma tumor model, an important cell type responsible for
facilitating tumor growth and proliferation. In addition, in
the preclinical melanoma model, the combination of ch1N11 with
anti-CTLA-4 or anti-PD-1 antibody developed protective
tumor-specific immunity to tumor re-challenge than either the
anti-CTLA-4 or anti-PD-1 antibody alone. Lastly, results
showed that the combination treatment of ch1N11 and anti-PD-1 led
to a proportional increase in tumor infiltrating cytotoxic T-cells,
while decreasing PD-L1 expression on tumor derived CD45 cells such
as tumor, endothelial and stromal cells as compared to anti-PD-1
alone.
"We now have compelling evidence from these preclinical studies
in multiple tumor models that PS-targeting antibodies mediate a
fundamental immune-stimulatory shift in the tumor environment,
facilitating increased antigen presenting cells as well as
tumor-specific cytotoxic T-cells," said Peregrine's Dr. Freimark.
"With the use of immunohistochemical staining, we have seen that
tumors from animals treated with ch1N11 in combination with
anti-PD-1 antibody showed faster and more complete T-cell and
macrophage tumor infiltration rates, which correlate with decreased
tumor cells, than anti-PD-1 alone. We look forward to further
exploring the potential of the bavituximab with other immune
checkpoint inhibitors."
In a poster titled: "Phosphatidylserine-Targeting Antibody
Synergizes with anti-PD-1 Antibody to Inhibit Tumor Growth in K1735
Mouse Melanoma Model," researchers from the University of Texas
Southwestern Medical Center summarized their findings that
PS-targeting antibodies block PS-mediated tumor immunosuppression
while reactivating tumor immunity at multiple levels. Specifically,
results showed that a PS-targeting antibody repolarized
tumor-associated macrophages (TAM) from an M2 to a M1-phenotype,
decreased the presence of myeloid-derived suppressor cells (MDSC),
promoted dendritic cell maturation into cells having the phenotype
of functional antigen presenting cells and elicited antitumor T
cell immunity. In addition, statistically signifcant differences
were seen in T-cell mediating markers IL-2 and gamma-interferon
with the ch-1N11 and PD-1 combination. Researchers concluded that
the combination of bavituximab with the anti-PD-1 checkpoint
blockade should synergistically induce potent long-lasting
antitumor immunity.
Abstract Details: Abstract Number 4978 Presentation Title:
Targeting of phosphatidylserine by monoclonal antibodies enhances
activity of immune checkpoint inhibitors in tumors Presentation
Time: Wednesday, April 9, 2014, 8:00 AM -12:00 PM Author Block:
Jian Gong, Van Nguyen, Shen Yin, Rich Archer, Jeff Hutchins, Bruce
Freimark. Peregrine Pharmaceuticals, Inc., Tustin, California
Late-Breaking Abstract Number: LB-262 Presentation Title:
Phosphatidylserine-targeting antibody synergizes with anti-PD-1
antibody to inhibit tumor growth in K1735 mouse melanoma model
Presentation Time: Tuesday, April 8, 2014, 1:00 PM - 5:00 PM Author
Block: Xianming Huang, Dan Ye, Rolf Brekken, Yi Yin. UT
Southwestern Medical Center, Dallas, Texas
Copies of these posters are available on the front page of
Peregrine's website.
About Bavituximab: A Targeted Investigational Immunotherapy
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting
monoclonal antibody that represents a new approach to treating
cancer. PS is a highly immunosuppressive molecule usually located
inside the membrane of healthy cells, but "flips" and becomes
exposed on the outside of cells that line tumor blood vessels,
creating a specific target for anti-cancer treatments. PS-targeting
antibodies target and bind to PS and block this immunosuppressive
signal, thereby enabling the immune system to recognize and fight
the tumor. These data detailing the immune-stimulatory mechanism of
action of PS-targeting antibodies, such as the company's lead drug
candidate bavituximab, are 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, breast cancer,
liver cancer and rectal cancer with a trial in advanced melanoma
anticipated to initiate in the near future.
About SUNRISE Trial: SUNRISE is a pivotal Phase III, randomized,
placebo-controlled, double-blind, multinational clinical trial
evaluating the efficacy and safety of bavituximab (bav i tux' i
mab), a novel investigational immunotherapy, plus docetaxel versus
placebo plus docetaxel as a second-line treatment for patients with
Stage IIIb/IV non-squamous non-small cell lung cancer (NSCLC). For
more information about the SUNRISE trial, please visit:
www.SunriseTrial.com
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 is developing multiple clinical programs in
cancer with its lead immunotherapy candidate bavituximab while
seeking a partner to further advance its novel brain cancer agent
Cotara®. 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. Additional information about Peregrine can be found at
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 results from human clinical studies
involving combinations of bavituximab with approved or
investigational immune checkpoint inhibitors may not correlate with
the data from the preclinical 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 SEC including, but not limited to, our
annual report on Form 10-K for the fiscal year ended April 30, 2013
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.
Christopher Keenan or Jay Carlson Peregrine Pharmaceuticals
(800) 987-8256 info@peregrineinc.com
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