AstraZeneca and Peregrine Pharmaceuticals Expand Ongoing Immuno-Oncology Collaboration to Include Phase II Lung Cancer Combin...
October 15 2015 - 8:05AM
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
that it has expanded its ongoing cancer immunotherapy clinical
collaboration with AstraZeneca to include a second, later-stage
trial. The companies will now also evaluate the immunotherapy
combination of Peregrine’s phosphatidylserine (PS)-targeted
immune-activator, bavituximab, and AstraZeneca’s anti-PD-L1 immune
checkpoint inhibitor, durvalumab (MEDI4736), in a global Phase II
study in patients with previously treated squamous or non-squamous
non-small cell lung cancer (NSCLC). The randomized Phase II
trial will be conducted by Peregrine.
As part of the Phase II bavituximab and
durvalumab combination trial, patients will be evaluated
retrospectively for the correlation between their PD-L1 levels and
clinical outcomes. This new study builds on the non-exclusive
collaboration initiated between the companies in August 2015 to
conduct a Phase I/Ib basket clinical trial evaluating the
combination of bavituximab and durvalumab with chemotherapy in
multiple solid tumors.
Bavituximab and durvalumab are investigational
immunotherapies with different mechanisms that assist the body's
immune system in fighting cancer. Bavituximab targets and modulates
the activity of phosphatidylserine, a highly immune-suppressive
molecule expressed broadly on the surface of cells in the tumor
microenvironment. In pre-clinical and translational clinical
studies, the treatment increases activated T-cells in tumors and
fights cancer by reversing the immunosuppressive environment that
many tumors establish in order to proliferate. Durvalumab is
a monoclonal antibody directed against programmed cell death ligand
1 (PD-L1). Signals from PD-L1 help tumors avoid detection by
the immune system. Preclinical data have demonstrated that
combining the enhanced T-cell mediated anti-tumor activity of
bavituximab with checkpoint inhibitors, like PD-L1 antibodies,
prolong the ability of tumor-specific T-cells to continue attacking
the tumor.
"In the short period of time that we have been
working with AstraZeneca, we have been very impressed with the
company’s commitment to innovative translational efforts that will
help us better understand the dynamics of tumor immunity and
clinical response to durvalumab and bavituximab combination in a
range of cancers," said Joseph Shan, MPH, vice president, clinical
and regulatory affairs of Peregrine. “We expect this extension of
our collaboration with AstraZeneca will allow us to run a much more
cost-effective and time-efficient trial than would have been
possible under our previously planned study using Opdivo as the
combination drug in the same lung cancer population. This
Phase II study offers several key advantages including a supply of
durvalumab that will enable us to conduct a global trial that can
enroll patients more rapidly. In addition, the expanded
collaboration provides for a more cohesive clinical program
utilizing the same PD-L1 and other biomarker analysis across both
the new Phase II trial and the already planned Phase I/Ib study
combining durvalumab and bavituximab in multiple indications.”
About Bavituximab: A Targeted
Investigational Immunotherapy
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. Bavituximab, the lead compound in Peregrine's
immuno-oncology development program, blocks PS to remove this
immunosuppressive signal and sends an alternate immune activating
signal. Targeting PS with bavituximab has been shown to shift
the functions of immune cells in tumors, resulting in robust
anti-tumor immune responses.
About durvalumab (MEDI4736)
Durvalumab is an investigational human monoclonal antibody
directed against programmed cell death ligand 1 (PD-L1). Signals
from PD-L1 help tumors avoid detection by the immune system.
Durvalumab blocks these signals, countering the tumor's
immune-evading tactics. Durvalumab is being developed, alongside
other immunotherapies, to empower the patient's immune system and
attack the cancer.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company
with a pipeline of novel drug candidates in clinical trials focused
on the treatment 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.
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.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of cardiovascular, metabolic, respiratory, inflammation,
autoimmune, oncology, infection and neuroscience diseases.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information please visit: www.astrazeneca.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
AstraZeneca decides not to provide its drug for a specific study,
the risk that the combination of bavituximab with PD-L1 and PD-1
based therapies will not increase the responsiveness of such PD-L1
and /or PD-1 therapies, the risk that the company may experience
delays in initiating the Phase II trial and the risk that data from
the initial clinical trial or the Phase II clinical trial does not
support further development of this treatment combination. 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,
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.
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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