-- Phase II Study in NSCLC in Collaboration with
AstraZeneca Evaluating Bavituximab Plus Durvalumab to Expand Lung
Cancer Program in Q1 2016 --
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 provided
a clinical development update for bavituximab, the company’s
investigational phosphatidylserine (PS)-targeting
immunotherapy. In the first quarter of 2016, Peregrine plans
to initiate two new Phase II clinical trials in breast and lung
cancer in combination with current standard of care treatments
including both chemotherapy and immuno-oncology agents. In
addition, the company has entered into a collaboration with the
National Comprehensive Cancer Network (NCCN) to evaluate
bavituximab in other tumor types and combinations.
Additionally, the company is nearing completion of enrollment
of an ongoing Phase III trial in non-small cell lung cancer (NSCLC)
named SUNRISE.
The planned trials include a Phase II NSCLC trial in combination
with AstraZeneca’s investigational anti-PD-L1 immune checkpoint
inhibitor, durvalumab (MEDI4736), and a Phase II trial in early
stage triple negative breast cancer (TNBC). These are in
addition to the recently initiated Phase II/III study in
combination with chemotherapy in human epidermal growth factor
receptor 2 (HER2)-negative metastatic breast cancer (MBC). The
company expects that initial data from these trials may be
available in late 2016 or early 2017. Additionally, the
company looks forward to the initiation of additional trials of
bavituximab combinations through its ongoing collaborations with
AstraZeneca and NCCN.
“As we wrap up enrollment in the SUNRISE trial,
we recognize that we are at an ideal juncture to continue expanding
the potential of bavituximab with standard of care and
immunotherapy combinations in multiple solid tumor types.
Combined with the SUNRISE trial, the new studies we have planned
can help solidify the potential of bavituximab in NSCLC while
significantly expanding the market opportunity in breast cancer,”
said Steven W. King, president and chief executive officer of
Peregrine. “Driving our strategy is the goal of further
demonstrating that bavituximab can provide therapeutic benefit to
available cancer treatments, regardless of whether those are
traditional therapies such as chemotherapy and radiation, or the
emerging novel class of immuno-oncology agents. In today’s
update, it is evident that we are moving aggressively to compile a
significant body of clinical evidence to support bavituximab’s
utility in multiple cancers and across a range of treatment
regimens. By doing so, we hope to optimally position
bavituximab for success.”
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 targeted inhibitor, bavituximab, is thought to reverse the
immunosuppressive environment that many tumors establish in order
to proliferate and spread, while also fighting cancer by activating
immune cells that target and fight cancer.
Updated details on Peregrine’s expanded
bavituximab clinical development program include:
Bavituximab in NSCLC:
Phase III SUNRISE Trial
Peregrine’s Phase III SUNRISE
(Stimulating ImmUne
RespoNse thRough
BavItuximab in a PhaSE III
Lung Cancer Study) trial is evaluating the use of bavituximab and
docetaxel in patients with previously treated locally advanced or
metastatic non-squamous NSCLC. Peregrine expects that the
first interim analysis (33% of targeted number of deaths) will be
conducted in early 2016 and the second interim analysis (50% of
targeted number of deaths) in mid-2016. The final analysis,
which will trigger the unblinding of the study data, is currently
projected to occur at the end of 2016.
Phase II NSCLC Trial in Combination with
AstraZeneca’s Durvalumab
Peregrine expects to initiate a global Phase II
study of bavituximab in combination with AstraZeneca’s durvalumab,
an anti-PD-L1 immune checkpoint inhibitor, in patients with
previously treated squamous or non-squamous NSCLC during the first
quarter of 2016. The goal of this trial is to generate data
on the combination of bavituximab and durvalumab to inform the
potential advancement of this treatment regimen into later stage
clinical trial. The study’s primary endpoints are overall
response rate (ORR) and safety. The trial is also designed to
retrospectively evaluate patients for the correlation between their
PD-L1 levels and clinical outcomes, providing further critical data
to guide future development.
The randomized, open-label trial will evaluate
approximately 200 patients at sites in the U.S. and Europe.
The company has filed a study protocol to its existing
investigational new drug (IND) application for bavituximab in the
U.S. and is currently working to open clinical trial sites.
Bavituximab in Breast
Cancer:
Phase II/III HER2-Negative MBC Trial in
Combination with Chemotherapy
In December 2015, Peregrine initiated an
open-label, randomized Phase II/III study comparing the efficacy
and safety outcomes for taxane monotherapy (paclitaxel or docetaxel
at investigator discretion) versus taxane therapy in combination
with bavituximab in HER2-negative MBC patients. The goal of
the Phase II portion of this study is to generate mature data on
the combination of bavituximab and chemotherapy in MBC to guide the
design and execution of the trial’s Phase III component. The
primary efficacy endpoint of the Phase II study is ORR, with
secondary endpoints including progression free survival (PFS),
overall survival (OS), duration of response and safety. The
Phase II portion of the study will enroll approximately 150
patients at sites in the U.S. and Europe.
Phase II Trial in Early Stage TNBC in
Combination with Chemotherapy
Peregrine is planning to initiate a Phase II
trial of bavituximab in combination with neoadjuvant chemotherapy
in early stage TNBC. The primary endpoint of this study is to
determine the pathologic complete response rate (pCR), an accepted
surrogate endpoint in early stage TNBC. The concept for this
neoadjuvant setting trial, which will be conducted at a few select
U.S. sites, originated from Peregrine’s ongoing collaboration with
Memorial Sloan Kettering Cancer Center (MSKCC). The company
has filed a study protocol to its existing bavituximab IND
application in the U.S. and is currently working to open clinical
trial sites, including one that will be led by David B. Page, M.D.,
at the Providence Cancer Center in Oregon.
Bavituximab in Other Solid Tumor
Indications:
Phase I/Ib Trial in Multiple Solid Tumors in
Combination with AstraZeneca’s Durvalumab and Chemotherapy
As part of the company’s collaboration with
AstraZeneca, Peregrine plans to initiate a Phase I/Ib study of
bavituximab in combination with durvalumab and chemotherapy in
multiple solid tumors in 2016. The Phase I part of the trial
is designed to confirm the tolerability of the combination of
bavituximab and durvalumab and establish a recommended dose regimen
for the Phase Ib part of the trial, which will assess the safety
and activity of the combination of bavituximab, durvalumab and
chemotherapy.
Multiple Clinical and Translational Studies in
Collaboration with NCCN
Peregrine recently announced a new research
collaboration with NCCN to expand the company’s ongoing clinical
research and development of bavituximab for the treatment of a
range of tumors. NCCN, a not-for-profit alliance of 26 of the
world's leading cancer centers devoted to patient care, research,
and education, is dedicated to improving the quality,
effectiveness, and efficiency of cancer care so that patients can
live better lives. Multiple investigator-initiated clinical
and correlative studies with bavituximab in multiple cancers will
be initiated at NCCN Member Institutions and their affiliate
community hospitals through a $2 million research grant to NCCN’s
Oncology Research Program (ORP). NCCN will be responsible for
oversight and monitoring of the clinical studies through the
research grant. The company expects results from this
collaboration to further support the ongoing development of
bavituximab as a key component of various combination cancer
treatments.
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 blocks PS
and, in turn, is believed to remove this immunosuppressive signal
and send an alternate immune activating signal. PS targeting
antibodies have been shown to shift the functions of immune cells
in tumors, resulting in robust anti-tumor immune responses.
About Peregrine Pharmaceuticals,
Inc.Peregrine Pharmaceuticals, Inc. is a biopharmaceutical
company focused on developing therapeutics to stimulate the body's
immune system to fight cancer. Bavituximab, the company's
lead immunotherapy candidate, is in late-stage clinical development
for the treatment of both lung cancer and breast cancer. The
company will also evaluate the combination of bavituximab and
durvalumab, AstraZeneca’s investigational anti-PD-L1 immune
checkpoint inhibitor, in a range of cancer types 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
company may experience delays in initiating planned clinical
trials, the risk that enrollment of patients in the company’s
clinical trials may experience delays, the risk that the results
from the Phase III SUNRISE trial may not support a future Biologics
License Application (BLA) submission, the risk that interim
analyses and data readouts from the clinical trials may not occur
within the time frames anticipated, the risk that the company may
not have or raise adequate financial resources to complete all of
its contemplated clinical trials, and the risk that data from one
or more of the Phase II and early stage clinical trials, including
ISTs, may not support further development of the combination and/or
indication studied. 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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