Avid Bioservices Inc (CDMO)

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PPHM’s Exosomes Technology: UTSW-DESC & World Patent #WO/2016/201064

6-30-16: UTSW WEBSITE - “AVAILABLE TECHNOLOGIES” (#2932):

“A Blood-based Diagnostic Test for the Early Detection of Cancer” (Alan Schroit, S.Ward, A.Gazdar)
ALL: http://www.utsouthwestern.edu/about-us/administrative-offices/technology-development/industry/available-technologies.html
SCHROIT/EXOSOMES #2932: http://www.utsouthwestern.edu/edumedia/edufiles/about_us/admin_offices/technology_development/available_technologies/utsd-2932.pdf
This invention is a highly sensitive, blood-based assay system for the diagnosis of cancer. Tumors secret large quantities of cell membrane-derived exosomes into the blood stream of cancer patients. While all exosomes, whether from tumor cells or normal cells, share membrane epitopes similar to those found on the parent cell membrane, only tumor cell-derived exosomes express the membrane phospholipid, phosphatidylserine (PS), in the outer leaflet of the particle membrane. Based on data clearly showing that PS exposure is a unique signature of tumor-derived exosomes, the investigators developed a discovery platform for the screening & detection of tumor-derived exosomal PS signatures in patient blood. This novel tool provides:
1) A diagnostic marker that could dramatically improve the early detection of cancer.
2) Predicts whether a tumor is benign or malignant.
3) Could provide a predictive marker for response to therapy. Importantly, early detection of indolent neoplastic disease could significantly improve patient survival.
Currently, there are very few blood tests for cancer. These include alpha-fetoprotein for hepatocellular cancer, CA125 for ovarian cancer, and prostate specific antigen for prostate cancer. Although, high levels of these proteins might indicate the presence of neoplastic disease, none are diagnostic. Because our system detects a shared universal marker of neoplastic disease, it provides a viable method for detecting cancer of any type, in any organ.

6-9-16/WORLD-PATENT: Pub# WO/2016/201064, Filed 6-9-16, pub. 12-15-16 (A.Schroit, S.Ward, A.Gazdar)
Title: “Diagnostic Test For Early Stage Cancer”
URL (patentscope.wipo.int): http://tinyurl.com/gqvwkga
ABSTRACT:
“Disclosed are methods of identifying tumor-derived exosomes as an early cancer diagnostic, as well as for staging, assessing progression, and assessing therapy of cancer.”
Inventors: Alan J. Schroit [UTSW, PPHM SAB]; Adi Gazdar [UTSW]; E. Sally Ward [Texas A&M]
Applicant: Board of Regents, The Univ. of Texas System, Peregrine Pharmaceuticals, Inc.
EXCERPT from SUMMARY:
“Detecting may comprise contacting the sample of step (b) with an exosome binding agent that may be the same or other phosphatidylserine binding agent than the one used in step (b), or a non-phosphatidylserine binding agent. Given that only PS-positive tumor exosomes are captured and available at this stage (after step b), the detecting agent may be an agent that binds to all exosomes regardless of their source… In general, normal tumor-free individuals have undetectable levels of PS-exosomes in an unconcentrated sample. In contrast, patients with tumors will typically exhibit values above 100 pg/50 \xh of sample in an unconcentrated sample. Thus, values greater than 50 pg/50 ui, plasma (or serum) are indicative of a malignancy. The method may further comprise obtaining said sample from the subject prior to step (a). The method may further comprise diagnosing the subject from which the sample was obtained as having cancer. The method may further comprise staging the cancer or classifying the cancer type in the subject from which the sample was obtained. The method may further comprise performing steps (a)-(c) a 2nd time, and comparing the results from the 1st & 2nd times, thereby assessing cancer progression or regression. The method may further comprise performing steps (a)-(c) a 2nd time, wherein the subject has received a cancer therapy after the 1st performance of steps (a)-(c) and before the 2nd performance of steps (a)-(c), and comparing the results from the 1st & 2nd times, thereby assessing the efficacy of cancer therapy. The method may further comprise treating the subject with a cancer therapy… In addition to PS, exosomes exhibit a number of unique & non-unique markers. Some of the exosome-specific markers include biomarkers that can help distinguish the nature of the type of cancer from which the exosome originated. Some exemplary exosome biomarkers can be found above in Table 1. Global exosome biomarkers that can be detected with appropriately labeled agents include cd9, cd63, cd81, ALIX, HSP70, TSG101, duramycin, and heparin.”


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PPHM's EXOSOME-BASED CANCER DETECTION & MONITORING TECHNOLOGY ("Liquid Biopsy")
...Excellent Exosome (aka microparticles, microvesicles) info: http://www.exosome-rna.com
2-9-17: Press Release on 1-22-17 OncoTarget Article: http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=1011223
1-22-17: OncoTarget article on PS-Exosomes: PPHM SAB’r Dr. Alan Schroit (UTSW): Proof-of-Concept data http://tinyurl.com/jg2k8pt
...Data (blinded plasma from 34 O.C. pts & 10 healthy subjects) supports the “high diagnostic power” of PS+ Exosomes in Ovarian Malignancies. “The data (Fig.4) show that quantification of PS-exosomes in blood distinguishes, with 100% accuracy, healthy tumor-free individuals from patients with ovarian malignancies.”
7-14-16: Peregrine Licenses Exosome-based technology from UTSW (Inventors: Alan Schroit/Philip Thorpe) http://tinyurl.com/zszd4fj
...“relates to assays that are able to detect small amts of PS+ Exosomes in a patient's blood sample as a way to detect cancer at a very early stage of development.”