Peregrine Pharmaceuticals Announces Presentation of Preclinical Study Results Highlighting Potential of PS-Targeting Antibodi...
April 03 2017 - 8:05AM
-- Latest Findings from Ongoing Collaboration
with Memorial Sloan Kettering (MSK) Support Potential Applications
for Combining CAR T and Anti-PS in Treatment of Solid Tumors --
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 positive new data
from the company’s ongoing collaboration with researchers from
Memorial Sloan Kettering Cancer Center (MSK). Presented
preclinical study results highlighted the potential of the
company’s phosphatidylserine (PS)-targeting antibodies to
enhance the anti-tumor activity of adoptive T cell transfer therapy
without triggering any off-target toxicities. Data were
presented this morning by MSK researchers 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.
For this study, a team of MSK researchers led by
cancer immunotherapy thought-leaders, Taha Merghoub, Ph.D. and Jedd
D. Wolchok, M.D., Ph.D., evaluated and compared the anti-tumor
activity and off-target toxicities of adoptive T cell transfer
therapy in combination with either PS-targeting antibodies or
anti-OX40 antibodies in mice with advanced melanomas. Whereas
PS-targeting and anti-OX40 demonstrated comparable tumor regression
when administered in combination with transferred adoptive T cells,
only the PS-targeting combination achieved these results without
any off-target toxicities. By contrast, the anti-OX40
treatment combination triggered off-target inflammatory destruction
of healthy tissues.
“While adoptive T cell transfer remains one of
the most exciting new approaches to treating cancer, to date the
toxicity associated with the treatment has limited its
potential. We are encouraged that these study results showed
that the combination of anti-PS and adoptive T cell treatment led
to enhanced anti-tumor effect without any evidence of additional
off-target side effects,” said Taha Merghoub, Ph.D., co-director of
the Ludwig Collaborative Laboratory at MSK. “We believe that
these findings may support potential applications for this
combination in solid tumors in the future.”
Additional study results demonstrated that the
PS-targeting antibodies decreased tumor-induced immunosuppression
as evidenced by a decrease in immunosuppressive regulatory T cells
(Tregs) and M2 macrophages. This finding is consistent with
Peregrine’s belief that bavituximab may modulate the
immunosuppressive tumor microenvironment and enhance the activity
of immunotherapy agents.
“These study results provide further support for
our belief that anti-PS agents such as bavituximab can play an
important role as part of combination cancer treatments. This
is directly tied to the agents’ ability to modulate the tumor
microenvironment to combat the immunosuppression that limits the
activity of CAR T and immunotherapies,” said Joseph Shan, vice
president of clinical and regulatory affairs at Peregrine.
“Importantly, we are now also seeing evidence that this targeted
modulation of the tumor microenvironment by anti-PS allows for
enhanced activity of these other treatments without triggering any
off-target toxicities. This is opposed to other conventional
immunotherapies such as anti-OX40 with systemic mechanisms of
action. We believe this advantageous tolerability profile will be a
key benefit in positioning anti-PS agents for inclusion in optimal
combination cancer regimens.”
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 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
results from the pre-clinical studies are not replicated in human
clinical trials and the risk that the company may not have or raise
adequate financial resources from debt and/or equity financings
and/or Avid's manufacturing operations to fund the further
development of bavituximab. 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:
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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