Peregrine Licenses Novel Exosome-Based Cancer Detection and Monitoring Technology from UT Southwestern Medical Center
14 July 2016 - 10:05PM
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a
biopharmaceutical company committed to improving patient lives by
delivering high quality biological products through its contract
development and manufacturing organization (CDMO) services and by
advancing its novel R&D pipeline, today announced that the
company has entered into an exclusive licensing agreement with
University of Texas (UT) Southwestern Medical Center for a novel
exosome technology that has potential application as a simple blood
test to detect or monitor cancer. The company intends to
develop a novel cancer test utilizing internal expertise and then
pursue revenue-generating partnering opportunities at an early
stage of development.
Tumor exosomes represent small pieces of tumor
cells that are released into the blood as tumors grow. Tumor
derived exosomes have phosphatidylserine (PS) on their surface as a
detectable marker. It is believed that even small tumors
begin to release PS-positive exosomes and thus the ability to
detect these exosomes in the blood may be an indicator of the
presence of a tumor.
The licensing agreement is the result of the
long-standing sponsored research agreement between Peregrine and UT
Southwestern focused on PS, a highly immunosuppressive signaling
molecule. The new technology licensed by Peregrine relates to
assays that are able to detect small amounts of PS-exosomes in a
patient blood sample as a way to potentially detect cancer at a
very early stage of development. Preliminary studies have
demonstrated that the levels of PS-positive exosomes present in the
blood of cancer patients are higher than levels found in the blood
of healthy volunteers. Furthermore, study findings also
suggest that there is a correlation between the level of
PS-positive exosomes detected in the blood of cancer patients and
disease burden.
“We are excited to enter into this licensing
agreement with our long-term collaborators at UT
Southwestern. This technology offers a promising product
development opportunity and aligns directly with the company’s
expertise with our proprietary PS-targeting platform and our
longstanding CDMO capabilities around the development,
qualification, and validation of in vitro analytical assays.
As such, there are significant opportunities to use this technology
as both a complementary tool in bavituximab’s ongoing development,
as well as more broadly as the basis for novel cancer detection and
monitoring tests that can be the focus of partnering efforts,” said
Jeff T. Hutchins, Ph.D., Peregrine’s vice president, preclinical
research. “It is important to note that this development
program will require minimal capital investment and has the
potential to create significant value over the next 18 months,
including potential partnering opportunities. As a result, we
feel that today’s licensing deal provides yet another important
driver in our ongoing efforts to achieve profitability.”
Together, the Peregrine and Avid Bioservices
teams have the existing infrastructure, staff and expertise to
develop, optimize and validate a functional assay capable of
detecting PS-positive exosomes from a blood sample. Given the
company’s extensive experience in developing assays of this type,
Peregrine does not anticipate the need to add personnel or any
specialized equipment for this project. The company intends
to establish clinical proof-of-concept for the test and expects to
initiate partnering discussions for the program in 2017.
“One of the most exciting aspects of this
technology is the potential synergy that it offers with our ongoing
bavituximab clinical development program. Through our ongoing
work with bavituximab, we have gained significant understanding of
PS-mediated immunosuppression in cancer,” said Joseph Shan, MPH,
vice president, clinical and regulatory affairs of Peregrine.
“The availability of a PS-specific biomarker which can be
implemented in our planned future bavituximab clinical trials
aligns nicely with our refocused bavituximab development strategy
aimed at generating the most meaningful data possible from small,
early stage clinical trials to support partnering efforts.”
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
company may not develop, or may experience delays in developing, a
commercializable and/or regulatory approvable test derived from the
licensed technology, the risk that the company experiences
difficulties in developing a test that is able to distinguish
between PS-positive exosomes from blood samples of cancer patients
and PS-positive exosomes from patients with other diseases or
illnesses that express PS-positive exosomes, the risk that the
Company is unable to generate partnering interest in the cancer
test, and the risk that the company is unable to secure patent
protection or other intellectual property protection for the cancer
test based on the licensed technology. 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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