Preclinical Data Presented at American Association for Cancer Research (AACR) Annual Meeting Demonstrate Enhanced Therapeutic...
April 20 2016 - 8:05AM
- Statistically Significant Improvement in
Overall Survival for Combination as Compared to Anti-PD-1 Therapy
Alone in TNBC Models; Combination Also Protects Against
Re-Challenge With TNBC Tumor Cells -
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a
biopharmaceutical company focused on developing therapeutics to
stimulate the body's immune system to fight cancer, today announced
the presentation of preclinical study data demonstrating enhanced
anti-tumor activity and immune activation for a combination of the
preclinical bavituximab equivalent (ch1N11) and anti-PD-1 therapy
in models of breast cancer including triple negative breast cancer
(TNBC). Additionally, new analysis conducted using the
nCounter® PanCancer Immune Profiling Panel from NanoString
Technologies® further validated previously reported findings
showing that the combination treatment induced a shift in the tumor
microenvironment from immunosuppressive to immune active.
This was evidenced by a distinct change in immune cell phenotypes,
as well as an increase in immune activating cytokines and decrease
in immunosuppressive cytokines. These study results, which
were presented at the 2016 American Association for Cancer Research
(AACR) Annual Meeting, provide further support for Peregrine’s
strategy of evaluating bavituximab in combination with a range of
novel immuno-oncology (I-O) agents for the treatment of various
cancers.
“These presented study results, particularly the
significant increase in overall survival and immunity to tumor
re-challenge seen with the treatment combination as compared to
anti-PD-1 therapy alone, continue to strengthen our collection of
translational and preclinical data supporting the potential for
bavituximab to enhance the therapeutic impact of I-O agents in the
treatment of cancer. In doing so, these data provide further
rationale for our clinical strategy focused on studying bavituximab
in combination with I-O agents targeting the PD-1/PD-L1 pathway in
a range of cancers,” stated Jeff T. Hutchins, Ph.D., Peregrine’s
vice president, preclinical research. “With a wealth of supportive
research in hand, we look forward to the continued advancement of
our clinical collaborations with AstraZeneca, the National
Comprehensive Cancer Network and Memorial Sloan Kettering Cancer
Center, to further evaluate the therapeutic potential of
bavituximab with novel I-O agent combinations.”
Bavituximab is an investigational immunotherapy
designed to assist the body's immune system by targeting and
modulating the activity of phosphatidylserine (PS), a highly
immune-suppressive signaling molecule expressed broadly on the
surface of cells in the tumor microenvironment. Peregrine’s
PS signaling pathway inhibitor candidates, including bavituximab,
reverse the immunosuppressive environment that many tumors
establish in order to proliferate, while also activating immune
cells that target and fight cancer. The preclinical
equivalent of bavituximab, ch1N11, is used in animal model studies
as a guide for clinical development.
As part of the study that was presented at AACR,
researchers evaluated the combination of ch1N11 and anti-PD-1
therapy versus anti-PD-1 stand-alone therapy in two
well-characterized murine models of TNBC (EMT-6 and E0771).
Study data showed that the combination therapy significantly
enhanced overall survival (p=0.0155) and was capable of mediating
complete tumor regressions in a greater number of subjects compared
to single agent treatments (60% vs. 20%). Data also
demonstrated that animals receiving combination treatment had
significant increases in tumor associated indicators of immune
system activation, including CD45+, CD8+ and CD3+ T-cells.
Importantly, the combination treatment led to a prolonged
anti-tumor immune response which protected the animals that
achieved a complete tumor regression against a re-challenge with
the same E0771 TNBC model tumor cells. This sustained anti-tumor
response demonstrates the ability of the combination treatment to
trigger immune system memory and support adaptive immune responses
against reemerging disease in this TNBC model. All study animals
experienced no signs of adverse effects or weight loss following
repeated doses of all therapeutic agents.
About Bavituximab: A Targeted
Investigational ImmunotherapyBavituximab 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.
About Peregrine Pharmaceuticals,
Inc.Peregrine Pharmaceuticals, Inc. is a biopharmaceutical
company developing therapeutics to stimulate the body's immune
system to fight cancer. The company is focused on evaluating
its lead immunotherapy candidate, bavituximab, in combination with
a range of novel immuno-oncology (I-O) agents for the treatment of
various cancers. One specific component of this I-O
combination strategy includes a planned clinical trial of
bavituximab in combination with durvalumab, AstraZeneca’s
investigational anti-PD-L1 immune checkpoint inhibitor, under a
clinical collaboration.
In addition to its drug development programs,
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 the
data from the preclinical study will not be duplicated in future
clinical studies. 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,
2015 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.
Jay Carlson
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
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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