Peregrine Pharmaceuticals Presents Preliminary Correlative Analysis of PD-L1 Expression from SUNRISE Trial at ASCO 2017
05 June 2017 - 10:05PM
-- Negative PD-L1 Expression was Associated with
a Significantly Longer Median Overall Survival Compared to Positive
PD-L1 Expression in Patients Receiving Docetaxel Plus Bavituximab
--
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a
biopharmaceutical company committed to improving patient lives by
advancing its proprietary R&D pipeline and manufacturing high
quality products for biotechnology and pharmaceutical companies,
today announced the presentation of promising new data from its
Phase III SUNRISE trial of bavituximab in patients with previously
treated locally advanced or metastatic non-squamous non-small cell
lung cancer (NSCLC). Presented results demonstrated that patients
in the study’s bavituximab treatment arm who had low baseline PD-L1
expression levels had a statistically significant improvement in
median overall survival (mOS) as compared to patients in the same
treatment arm who had higher baseline levels of PD-L1. Data
were presented by Peregrine scientists at the Annual Meeting of the
American Society of Clinical Oncology (ASCO), being held June 2 -
6, 2017 in Chicago.
Data presented demonstrated that patients in the
study’s docetaxel plus bavituximab (D+B) treatment arm with a
pre-treatment PD-L1 expression level on tumor cells of <1% (TC0)
had a mOS of 12.1 months compared to a mOS of 6.1 months for
patients with PD-L1 expression ≥1% (TC1/2/3) (HR = 0.42
p=0.007). There was no difference in mOS based on PD-L1
expression levels observed in the study’s docetaxel plus placebo
(D+P) control arm (10.7 months for TC0 vs. 11.1 months for TC1/2/3;
HR = 0.87; p=0.609).
“We believe that these latest observations from
the SUNRISE trial further support the hypothesis that bavituximab,
through its immune modulating mechanism, may have more effect on
tumors without pre-existent immunity. These ‘cold’ tumors
suppress normal anti-tumor immune response and are categorized by
very low to no PD-L1 expression on tumor cells,” said Joseph Shan,
vice president of clinical and regulatory affairs at Peregrine.
“These latest findings, along with other recently announced
clinical and preclinical data from our PS-targeting program, inform
our clinical development strategy going forward and provide
additional rationale for combining bavituximab with checkpoint
inhibitors.”
As part of the SUNRISE clinical study protocol,
researchers requested but did not require that patients provide a
tumor tissue sample at the time of diagnosis. In total,
tissue samples were collected from 129 of the trial’s 597 patients
and were assessed retrospectively for baseline PD-L1 expression
levels on tumor cells. Of the 129 tissue samples collected,
122 were evaluable for PD-L1 expression on tumor cells (54 in D+B
arm and 68 in D+P control arm). Of the evaluable samples in the D+B
arm, 69% demonstrated PD-L1 expression levels <1%, as compared
to 59% in the D+P arm.
Bavituximab is an
investigational immune-modulatory monoclonal antibody
that targets phosphatidylserine (PS). PS inhibits the ability
of immune cells to recognize and fight tumors. Bavituximab is
believed to reverse PS-mediated immunosuppression by
blocking the engagement of PS with its receptors as well as by
sending an alternate immune activating signal. PS-targeting
antibodies have been shown to shift the functions of immune cells
in tumors, resulting in multiple signs of immune activation and
anti-tumor immune responses.
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 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 (MSK) with the goal of evaluating combinations of PS
targeting antibodies with checkpoint inhibitors and other immune
stimulatory agents. Peregrine’s intent behind this strategy
is to focus its research and development spending to further
validate bavituximab's combination potential as the company seeks
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 data
from future bavituximab clinical trials may not show a
statistically significant increase in median overall survival for
bavituximab treated patients with PD-L1 expression levels of
<1%. 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
Avid Bioservices (NASDAQ:CDMO)
Historical Stock Chart
From Apr 2024 to May 2024
Avid Bioservices (NASDAQ:CDMO)
Historical Stock Chart
From May 2023 to May 2024