Peregrine Pharmaceuticals, Inc., a biopharmaceutical company, 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.

tumour exosomes represent small pieces of tumour cells that are released into the blood as tumours grow. tumour derived exosomes have phosphatidylserine (PS) on their surface as a detectable marker. It is believed that even small tumours 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 tumour.

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."