-- Promising Results of MSK Study Evaluating
Combinations of PS-Targeting Treatment, Anti-PD-1 and Radiation in
Mouse B16 Melanoma Model Presented at SITC 2016 --
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 data from
multiple new preclinical studies of the company’s
phosphatidylserine (PS)-targeting antibodies. Study results
highlight that PS-targeting antibodies similar to bavituximab
synergize with checkpoint inhibitors and radiation to improve
anti-tumor activity in various animal tumor models. Importantly,
the improved anti-tumor activity seen in these studies was even
greater when PS-targeting therapy was a part of triple combination
treatment including anti-PD-1 and another therapy. Data were
presented by Peregrine scientists, as well as researchers from
Memorial Sloan Kettering Cancer Center (MSK), at the Society for
Immunotherapy of Cancer (SITC) 2016 Annual Meeting, which was held
November 9-13, 2016 in National Harbor, MD.
Initial results from Peregrine’s ongoing
collaboration with MSK researchers were featured in a poster
presented by Sadna Budhu, Ph.D., at SITC 2016. A team of MSK
researchers led by cancer immunotherapy thought-leaders, Taha
Merghoub, Ph.D. and Jedd D. Wolchok, M.D., Ph.D., evaluated the
effects of combining PS-targeting, anti-PD-1 and radiation
therapies in the mouse B16 melanoma model. Study data showed
that PS-targeting antibodies synergize with both anti-PD-1 and
radiation therapy to improve anti-cancer activity.
PS-targeting treatment in combination with radiation, as well as
triple combination of PS-targeting treatment, anti-PD-1 and
radiation, led to a reduction in tumor burden. Median
survival for the triple combination treatment still had not been
reached at the end of the 80-day observation period with other arms
in the study showing median survival that ranged from 24-70
days.
Researchers also evaluated the impact of the
PS-targeting and radiation combination treatment on the level and
type of immune activity. These results demonstrated that the
combination led to a change in the tumor microenvironment, shifting
it from immunosuppressive in which tumors are protected to immune
active in which tumors are more susceptible to treatment.
Analysis of local immune responses in the tumors of the treated
animals showed that the combination treatment increased the number
of tumor associated macrophages and shifted the macrophage
polarization from the immunosuppressive M2 type to the immune
active M1 type. When systemic immune responses were analyzed
following triple combination of PS-targeting treatment, anti-PD-1
and radiation, researchers also saw evidence of increased immune
activity. This was illustrated by key indicators of immune
activity, including increases in CD8+ T-cell activation, effector
cytokine production and differentiation into effector memory
cells.
“Based on these study results, we believe that
the targeting of PS is having meaningful activity within the tumor
microenvironment in the B16 melanoma model,” stated Dr.
Wolchok. “It appears that this activity creates a more immune
active environment in which other treatments, including radiation,
are able to have a greater anti-tumor impact.”
“We have noted that the combination of
PS-targeting treatment and radiation, as well as triple combination
of PS-targeting treatment, radiation and anti-PD-1, resulted in
clear advantages in anti-tumor activity in the mouse B16 melanoma
model,” said Taha Merghoub, Ph.D., co-director of the Ludwig
Collaborative Laboratory at MSK. “We believe that these
findings suggest the potential benefit of combining these agents to
improve the outcomes of patients with cancer. With this in
mind, we think this research may play an important role in
designing future clinical trials of PS-targeting agents in melanoma
and other cancers.”
A second study, conducted by Peregrine,
evaluated the effects of combining PS-targeting, anti-PD-1 and
anti-LAG3 therapies in the E0771 triple negative breast cancer
(TNBC) model. Initial findings from this study were
previously reported and demonstrated that eight of the ten (80%)
animals receiving the PS-targeting, anti-PD-1 and anti-LAG3
treatment 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. New
data presented for the first time at SITC demonstrated that the
triple combination established a specific and prolonged anti-tumor
immune response which protected those eight 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 triple combination
treatment to trigger immune system memory and support adaptive
immune responses against reemerging disease in the E0771 TNBC
model.
Further highlighting the immune impact of the
PS-targeting/anti-PD-1/anti-LAG3 treatment combination were initial
results of a new analysis from this study using the nCounter®
PanCancer Immune Profiling Panel from NanoString
Technologies®. Data from the analysis demonstrated that the
triple combination induced a greater shift in the tumor
microenvironment from immunosuppressive to immune active as
compared to all other treatment groups. This was evidenced by
greater increases in the activity of several critical immune
activating pathways, including presentation and processing of
antigens and signaling and activation of T-cells, for the triple
combination as compared to all other treatments.
“It is very encouraging to see the consistent
increase in anti-tumor activity triggered by triple combination
treatments that combine PS-targeting agents and anti-PD-1 with
other cancer treatments. By demonstrating this activity
across multiple studies in multiple tumor models, we are continuing
to build scientific support for the therapeutic potential of adding
PS-targeting therapies in combination with other cancer treatments,
including checkpoint inhibitors such as anti-PD-1,” said Jeff T.
Hutchins, Ph.D., Peregrine’s vice president, preclinical
research. “As cancer research continues to explore the
potential of combination treatments that marry complementary
mechanisms, we are pleased to see that our efforts continue to
generate data supporting the role that PS-targeting agents such as
bavituximab may play in this area.”
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 continues to support and
guide clinical development through the evaluation of the
preclinical equivalent of bavituximab, ch1N11, in animal model
studies.
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 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
data from these preclinical studies 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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