Avid Bioservices Inc (CDMO)

[cjgaddy]

7-14-16/PR: Peregrine Licenses Exosome-Based Cancer Detection/Monitoring from UTSW.
...See May'14 J.Immunol.Methods article (below) by Alan Schroit/Philip Thorpe, "A Novel 'Salting-Out' Procedure For The Isolation Of Tumor-Derived Exosomes”.
...Also, see U.S./Intl. Patent App's 20150241431/WO2015131153, filed 2-27-15 at bottom of this post (”Methods & Compositions For Isolating Exosomes”)…

7-14-16: Peregrine Licenses Novel Exosome-Based Cancer Detection and Monitoring Technology from UT Southwestern Medical Center
--New Technology Efficiently Builds on the Company's Existing Phosphatidylserine (PS) Targeting Platform and Assay Development Capabilities
--Stand Alone Program That Offers Significant Value Creation Potential and Early Partnering Opportunities
--New Technology to Also be Evaluated in Conjunction with Ongoing Bavituximab Clinical Development Program
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=979554

TUSTIN, July 14, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/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 VP, 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, VP, Clinical & 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. ( http://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 http://www.peregrineinc.com .
Safe Harbor *snip*
Contacts: Jay Carlson Peregrine Pharmaceuticals, Inc. [phone] [e-mail]
Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 [e-mail]
Tim Brons (Media) Vida Strategic Partners 415-675-7402 [e-mail]

= = = = = = = = http://www.ncbi.nlm.nih.gov/pubmed/24735771
J Immunol Methods, May 2014 Epub 4-13-14.
“A Novel 'Salting-Out' Procedure For The Isolation Of Tumor-Derived Exosomes”
Brownlee Z, Lynn KD, Thorpe PE, Schroit AJ [PhD, PPHM SAB http://tinyurl.com/hnvps2l ]
Simmons Comprehensive CC, Dept of Immunology, UTSW-MC/Dallas
ABSTRACT:
The last decade has seen an exponential growth in the number of exosome-related publications. Although many of these studies have used exosomes from biological fluids (blood, and ascites or pleural effusions) the vast majority employed vesicles isolated from large volumes of tissue culture supernatants. While several techniques are available for their isolation, all require a significant reduction in volume to obtain sufficient concentrations for study. One approach is to concentrate the medium before proceeding with their isolation, however, these procedures are very time consuming and require specialized laboratory equipment. Here we provide a new and effective method for the isolation of tumor-derived exosomes based on "charge neutralization" with acetate. We show that titration of tissue culture supernatants with 0.1M acetate to pH4.75 results in immediate precipitation of virtually all the exosomes. The precipitated exosomes can be washed to remove residual media and are readily "resolubilized" upon resuspension in acetate-free buffer at neutral pH. This simple cost effective method significantly increases the yield of exosomes from an unlimited quantity of culture supernatants. Exosomes isolated by this technique are indistinguishable from exosomes recovered by direct ultracentrifugation.

= = = = =
U.S. Patent App# 20150241431 - Filed 2-27-15, Pub. 8-27-15
”Methods & Compositions For Isolating Exosomes”
USPO: http://tinyurl.com/hlcxb7f
Applicants: BOARD OF REGENTS, THE UNIV. OF TEXAS SYSTEM; PEREGRINE PHARMACEUTICALS, INC.
Inventors: SCHROIT, Alan, J.; THORPE, Philip, E.; Fussey; Shelley P.M.
Abstract: Disclosed are surprising new methods & compositions for isolating extracellular microvesicles such as exosomes, particularly disease-related and phosphatidylserine (PS)-positive extracellular microvesicles as exemplified by tumor- and viral-derived exosomes. The methods of the invention are rapid, efficient, cost-effective and, importantly, are suitable for use with large volumes of biological fluids and produce antigenically intact extracellular microvesicles and exosomes. The methods and compositions are based on the surprising use of acetate buffers to isolate large quantities of extracellular microvesicles, particularly tumor-derived exosomes, from solution, without damaging their morphological or functional properties or antigenicity.
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INTL. PATENT APP# WO/2015/131153, Filed 2-27-15, Pub. 3-9-15
”Methods & Compositions For Isolating Exosomes”
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2015131153