Data Presented at AACR Demonstrate Peregrine Pharmaceuticals' Bavituximab Induces Immune Activation in PD-L1 Negative NSCLC T...
April 20 2015 - 8:00AM
- Bavituximab Alone and in Combination with
Docetaxel Elicit a Tumor-Specific Immune Response in PD-L1 Negative
Tumors Extracted from NSCLC Patients -
- Immune Modulating Results Consistent with
Previously Conducted Translational Studies in Liver Cancer -
- Presented Data Further Support Clinical Studies
Evaluating the Effectiveness of Bavituximab Immunotherapy
Combinations in Patients with PD-L1 Negative Tumors -
Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP) today
announced the presentation of data from clinical translational
studies of the company's phosphatidylserine (PS)-targeting
immunotherapy bavituximab. Initial data from a pilot study of
clinical translational ex vivo cultures show that bavituximab, both
alone and with docetaxel, elicits evidence of a tumor-specific
immune response in patients with human adenocarcinoma of the lung
and that bavituximab exhibits an impact on tumors with negative
PD-L1 expression. These data were presented yesterday, Sunday,
April 19th, in a poster presentation at the 106th Annual Meeting of
the American Association for Cancer Research (AACR) being held in
Philadelphia, Pennsylvania from April 18-22, 2015. Bavituximab is
currently being evaluated in second-line non-small cell lung cancer
(NSCLC) as part of the SUNRISE pivotal Phase III clinical
trial.
"Our translational findings of a cytokine profile that reflects
an immune response following either bavituximab single-agent or
combination treatment are encouraging. Furthermore, these
preliminary translational data show that tumors with negative PD-L1
expression and low levels of PD-1 expression on CD8+ tumor
infiltrating T cells showed immune response to bavituximab
treatment ex vivo," said Sigrid M. Volko, Ph.D., CLP the lead
investigator on the study and President and Chief Executive Officer
of Nilogen Oncosystems. "It is an exciting time for the field of
immunotherapy and the data we have been generating support that
bavituximab has the potential to activate a tumor specific immune
response in patients with PD-L1 negative tumors that generally do
not respond as well to PD-1 or PD-L1 inhibitors."
In a poster titled: "Bavituximab modulates tumor
microenvironment and activates CD8+ tumor infiltrating lymphocytes
in a patient-derived 3D ex vivo system of lung cancer," researchers
from Moffitt Cancer Center, Nilogen Oncosystems and Peregrine
present initial data from a pilot translation study analyzing tumor
tissue from six lung cancer patients to evaluate the
immunomodulatory effects of bavituximab in a human ex vivo model of
NSCLC. Researchers generated 3D tumor microspheres from tumor
tissues produced at the time of surgical resection. These
microspheres were treated ex vivo for 36 hours with bavituximab,
bavituximab and docetaxel, or controls in the presence of
Interleukin-2 (IL-2), a cytokine that regulates the activities of
white blood cells that are responsible for immunity. Data show that
bavituximab as a single agent or in combination with docetaxel
induces lymphocyte activation in tumors as demonstrated by a
significant increase in interferon-gamma (IFNγ), TNF-alpha, and
GM-CSF secretion when compared to tumors treated with IL-2 control.
Researchers also concluded that the immune response to treatment
with bavituximab correlates with negative PD-L1 expression in the
resected tumor tissue and low PD-1 expression on CD8+ tumor
infiltrates thus serving as a potential prognostic biomarker of
positive response to bavituximab treatment.
"These data are exciting as the immune responses seen in this
translational lung cancer study mirror what we saw in translational
data from a liver cancer clinical trial and is perfectly aligned
with what has been seen preclinically to date. It was also
encouraging to see how well these data further support our ongoing
Phase III SUNRISE trial in that the combination of bavituximab and
docetaxel induces immune activity," said Joseph Shan, MPH, vice
president of clinical and regulatory affairs at Peregrine. "These
data are playing a key role in advancing the clinical portion of an
Immuno-Oncology Development Program which has been built upon a
growing body of favorable data supporting the potential combination
of bavituximab and checkpoint inhibitors. Specifically, these data
show that activating the immune system in this negative PD-L1
patient population provides a strong rational for combining
bavituximab with inhibitors of the PD-1/PD-L1 pathway. We look
forward to detailing our plans for additional immuno-oncology
combination clinical trials in the near future."
Liver Cancer Translational Data
In November, clinical translational data from the company's
Immuno-Oncology Development Program were presented assessing
changes in immune response pre- and post-treatment in six patients
participating in a Phase II IST evaluating bavituximab in
combination with sorafenib in advanced hepatocellular carcinoma.
Data from this translational sub-study of patients, show that half
of the patients had an increase in tumor fighting immune cells
following one cycle of treatment, similar to what has been shown
for PS-targeting antibodies in multiple preclinical cancer models.
In addition, the increase in immune response was associated with
patients that remained on study treatment for longer time periods,
consistent with an immunotherapeutic mechanism and suggest the
possibility of a clinically meaningful anti-tumor immune response.
Immune responding patients also had increased infiltration of CD8
T-cells in the tumor microenvironment which correlated with a
prolonged time to disease progression. In addition, these immune
responders expressed lower levels of PD-1, an established marker of
T cell activation and disease outcome, prior to the initiation of
therapy, followed by a measurable rise.
A link to this presentation is located on the front page of
Peregrine's website at www.peregrineinc.com.
About Bavituximab: A Targeted Investigational Immunotherapy
Scientific research has shown that tumors evade immune detection
due partly to the expression of phosphatidylserine, or PS, a highly
immunosuppressive molecule. Peregrine's immuno-oncology development
program has developed bavituximab, an investigational monoclonal
antibody that targets and binds to PS, blocking its
immunosuppressive effects while activating tumor fighting immune
cells, thus enabling the immune system with the ability to better
recognize and fight cancer. Bavituximab's immune-stimulatory
mechanism-of-action data is the subject of a manuscript published
in the October 2013 issue of the American Association for Cancer
Research's (AACR) peer-reviewed journal, Cancer Immunology
Research. Bavituximab is currently being evaluated in several solid
tumor indications, including non-small cell lung cancer (the
SUNRISE Phase III trial), breast cancer, rectal cancer and advanced
melanoma. In January 2014, bavituximab received Fast Track
designation by the U.S. Food and Drug Administration (FDA) as a
potential second-line treatment in patients with non-small cell
lung cancer.
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'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.
The company is also advancing a molecular imaging agent,
124I-PGN650, in an exploratory clinical trial for the imaging of
multiple solid tumor types. 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 data from human clinical studies may not
correlate with data from translational and pre-clinical studies may
not correlate with the results from human clinical 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
Securities and Exchange Commission including, but not limited to,
our annual report on Form 10-K for the fiscal year ended April 30,
2014 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.
CONTACT: Christopher Keenan
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
Avid Bioservices (NASDAQ:CDMO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Avid Bioservices (NASDAQ:CDMO)
Historical Stock Chart
From Sep 2023 to Sep 2024