Avid Bioservices Inc (CDMO)

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2-9-15 PR: Dr.Freimark’s Oral-Pres. at Keystone Tumor-Immunology Meeting, Banff/CN… (Bavi MOA - Poster #1056 & Slideshow Images)

Newly Presented Data Shows That Peregrine Pharmaceuticals' PS-Targeting Antibodies Significantly Enhance Anti-Tumor Activity of Immune Checkpoint Inhibitors PD-1 and CTLA-4 in Models of Breast Cancer and Melanoma
• PS-Targeting Antibodies Block Tumor Suppression of Immune System Allowing Development of Robust Immune Responses Resulting in Statistically Significant Improvement in Anti-Tumor Activity
• Specific Effects Seen in Decreased Levels of MDSCs and Other Immunosuppressive Lymphocytes and Increases in Tumor Fighting Immune Cells
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=895363

TUSTIN, 2/09/15: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP) today announced preclinical data presentations showing that the PS-targeting antibody equivalent to bavituximab combined with an anti-PD-1 antibody displayed statistically significant improvement in tumor fighting immune cells, activation signals and cytokines in a model of melanoma compared to anti-PD-1 alone. Moreover, cells that suppress the immune system from recognizing tumors, such as myeloid-derived suppressor cells (MDSCs), were reduced by more than 40% in the combination with the PS-targeting antibody versus anti-PD-1 alone. These data, further validating the immune-stimulatory mechanism of bavituximab, are outlined in an oral and poster presentation by Bruce Freimark, Ph.D., Director, Preclinical Oncology Research at Peregrine, to be made at the Keystone Tumor Immunology: Multidisciplinary Science Driving Combination Therapy meeting being held February 8-13, 2015 in Banff, Alberta, Canada [ http://www.keystonesymposia.org/15J7 ]. Peregrine's lead PS-targeting antibody, bavituximab, is currently being evaluated in second-line non-small cell lung cancer (NSCLC) as part of the SUNRISE pivotal Phase III clinical trial [ 5-31-14/ASCO: http://tinyurl.com/nv4jloo ].

"These data build on our growing body of encouraging combination data and strengthen our clinical development plans as we evaluate the direction of combination therapy trials utilizing bavituximab and other checkpoint inhibitors" said Jeff T. Hutchins, Ph.D., Vice President Of Preclinical Research at Peregrine. "Our goals are to modify a tumor environment that allows more patients to respond to conventional and immune therapy. As the tumor environment switches from immuno-suppressive to immuno-stimulatory with bavituximab treatment, we believe the addition of other checkpoint inhibitors, like anti-PD-1, may increase the number of patients responding to therapy."

In the presentations titled: "Antibody-Mediated Blockade of Phosphatidylserine Enhances the Anti-Tumor Activity of Immune Checkpoint Inhibitors by Affecting Myeloid-Derived Suppressor Cells (MDSC) and Lymphocyte Populations in the Tumor Microenvironment", Dr. Freimark and his research group, along with colleagues from the University of Texas Southwestern Medical Center led by Xianming Huang, Ph.D., demonstrate that in immunocompetent preclinical models of breast cancer and melanoma, the combination of PS-targeting antibodies and anti-CTLA-4 and anti-PD1 antibodies demonstrate statistically significant anti-tumor responses than either anti-CTLA-4 or anti-PD-1 antibody alone. New data presented show statistically significant changes in levels of tumor infiltrating lymphocytes (TILs), a type of white blood cell implicated in killing tumor cells, in the PS-targeting and anti-PD-1 combination group over single treatment alone in a melanoma model. Specifically, data show increases in a number of markers used to determine immune activation, including CD3 and CD8 cells expressing PD-1, Lag-3 and CD137 (4-1BB). Furthermore, data show that CD8 T cells in the tumor had increased production of IFN-gamma and TNF-a, both known to assist in promoting immune activation and Granzyme-B which is involved in direct tumor killing.

ABOUT KEYSTONE SYMPOSIA
Keystone Symposia serve as a catalyst for the advancement of biomedical and life sciences by connecting scientists within and across disciplines at conferences and workshops held at venues that create an environment conducive to information exchange, generation of new ideas and acceleration of applications that benefit society. Links to these presentations can be found on the front page of Peregrine's website at http://www.peregrineinc.com .
=> [ http://www.peregrineinc.com/images/stories/pdfs/bf_keystone_2015.pdf
http://www.peregrineinc.com/images/stories/pdfs/bf_slides_keystone.pdf ] *See Poster & Slide Pics Below*

About Bavituximab: A Targeted Investigational Immunotherapy
Scientific research has shown that tumors evade immune detection due partly to the expression of phosphatidylserine, or PS, a highly immunosuppressive molecule. Peregrine's immuno-oncology development program has developed bavituximab, an investigational monoclonal antibody that targets and binds to PS, blocking its immunosuppressive effects while activating tumor fighting immune cells, thus enabling the immune system with the ability to better recognize and fight cancer. Bavituximab's immune-stimulatory mechanism-of-action data is the subject of a manuscript published in the October 2013 issue [ Online 8-19-13: http://tinyurl.com/mhjftka ] of the American Association for Cancer Research (AACR) peer-reviewed journal, Cancer Immunology Research. Bavituximab is currently being evaluated in several solid tumor indications, including non-small cell lung cancer (the SUNRISE Phase III trial), breast cancer, liver cancer, rectal cancer and advanced melanoma. In January 2014, bavituximab received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment in patients with second-line non-small cell lung cancer.

ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities 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. For more information, please visit http://www.peregrineinc.com .
Safe Harbor *snip*
Contact: Christopher Keenan Peregrine Pharmaceuticals, Inc. 800-987-8256 [e-mail]

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Dr. Bruce Freimark’s KEYSTONE Oral Pres. Feb9 2015 on Bavi MOA (10 slides):




















Dr. Bruce Freimark’s KEYSTONE Poster #1056 Feb9 2015 on Bavi MOA:

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SCIENCE: "Evolution has favored pathogenesis that resembles apoptosis."
Dr. Judah Folkman: <i.”This [Thorpe’s VTA research] is very promising and very elegant work... The whole goal is really 2-part, reducing the harsh side effects of cancer treatment, and reducing the chance that some cancer cells will evade treatment. That would be a big step in the next decade, and anti-vascular therapy will play a major role." (’97 & ’02 http://tinyurl.com/k5qe96g & http://tinyurl.com/n6vh9hp )
Peregrine's Bavituximab Clinical Trials website: http://PeregrineTrials.com
Bavituximab MOA & Clinical Data: http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
...Bavi Publications: http://www.peregrineinc.com/publications/publications.html
...Bavi Posters & Presentations: http://www.peregrineinc.com/publications/posters-and-presentations.html
Bavi MOA: Video (3:34) added ~3-2014 http://vimeo.com/87116642 "Bavituximab: A Novel Immunotherapy Candidate Targeting an Upstream Immune Checkpoint to Fight Cancer"
Bavi MOA: Video (1:33) on Bavi’s Immunotherapeutic MOA added to Youtube on 3-27-14 https://www.youtube.com/watch?v=Esewl35JD8s
BAVI MOA 2-9-15: PPHM/VP Dr. Bruce Freimark’s presentation at KEYSTONE "Tumor Immunology Meeting", Banff/CN – PR & Slides: http://tinyurl.com/q6cx4w6
BAVI MOA 12-12-14 San Antomio Breast Cancer Symposium, Dr. Bruce Freimark, Bavi+anti-PD-1 vs. Breast Cancer http://tinyurl.com/p5ng6vs
BAVI MOA 11-2014 SITC’14: 3 posters on preclin. Bavi+aCTLA4/aPD1 combo data (Hutchins Freimark Brekken Huang etal) http://tinyurl.com/pchzr6h
BAVI MOA 8-28-14: Italy’s Dr. Federico Cappuzzo, Bavi/NSCLC profile article (DovePress OpenAccess, 7pgs) - http://tinyurl.com/n3oa7bc
BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme
...MLV’s Dr. George Zavoico’s 8-27-14 report on Dr. Jeff Hutchins’ 8-11-14 ImVacS/Boston Bavi MOA presentation: http://tinyurl.com/l3tw63c
BAVI MOA 5-28-14: Dr. Rolf Brekken’s 47min CRI “Cancer Immunotherapy” webinar about Bavituximab as an Upstream/Global Immune Checkpoint Inhibitor – REPLAY: http://tinyurl.com/lxgftyx
. . .CRI=Cancer Research Institute (NYC – Supported by BMS): http://www.cancerresearch.org - Facebook: http://tinyurl.com/pbmhb2z , https://twitter.com/CancerResearch
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
. . .8-12-14: CRI adds Youtube links to the 5-28-14 CRI Immunotherapy webinar, incl. Dr. Brekken's talk "about Bavi and how it works against lung, liver, and other kinds of cancers" http://tinyurl.com/ps5h6h8
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
12-10-13: With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone**, Hakan Mellstedt http://tinyurl.com/mw776mk
......**A/o 9-2014, Dr. David Carbone (PPHM SAB/KOL) is President-Elect of IASLC https://www.iaslc.org/about-us/board
BAVI MOA: 12-2013 Bavi’s Immunotherapeutic MOA overviewed by UTSW’s Brekken/Huang in Pan European Networks Jrnl. http://tinyurl.com/lnb46pq
BAVI MOA 11-9-13: Annual SITC (WashDC) – 2 posters about Bavi’s Immunostimulatory MOA http://tinyurl.com/mjaweu5
...“We are actively working towards initiating a clinical trial in the coming months to further investigate the potential synergistic effects of bavituximab and an approved [anti-CTLA-4] immunotherapy in patients with Melanoma."
10-28-13 IASLC/Sydney: “Immune Checkpoints in the Tumor Environment: Novel Targets & the Clinical Promise of Combined Immunotherapies” http://tinyurl.com/mjaweu5
…Symposium speakers: Scott J. Antonia/MD-PhD(H.Lee Moffitt CC), Dmitry I. Gabrilovich/MD-PhD(Wistar Inst), Rolf A. Brekken/PhD(UTSW), David E. Gerber/MD(UTSW)
BAVI MOA: 8-19-13 Data Supporting Bavituximab’s Immunotherapy MOA Published in “Cancer Immunology Research” (AACR) - http://tinyurl.com/mhjftka (PDF)
…“PS-Targeting Antibody Induces M1 Macrophage Polarization & Promotes Myeloid-Derived Suppressor Cell Differentiation” (Thorpe etal)
BAVI MOA: 8-13-13 PPHM/VP Dr. Jeff Hutchins’ Presentation on the Downstream Immunostimulatory Effects/Moa of PS-targeting antibodies (like Bavi) at CHI’s “Immunotherapies Congress”/Boston http://tinyurl.com/m6h2tvt
BAVI MOA: 10-12-12 NMB article on how Bavi "Induces Innate & Specific Anti-tumor Responses" http://tinyurl.com/cw9odb8
BAVI MOA: 5-1-12 Dr. Phil Thorpe's 46min talk at NYAS PS-Targeting Symposium http://tinyurl.com/9792gl5
. . .Symposium title: "Phosphatidylserine (PS) Asymmetry - Therapeutic Apps. in Cancer & Infectious Disease Symposium"
. . .Replays of 5 speakers: Alan Schroit, Chris Reutlingsperger, David Ucker, Ari Helenius, Philip Thorpe

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O. 6th IST Trial: Bavi+Ipilimumab(Yervoy) vs. Adv.Melanoma (Ph1b, random, open-label, 2arms, n=24)
Protocol (UTSW): http://www.clinicaltrials.gov/ct2/show/NCT01984255 (PI: Dr. Arthur Frankel - see "Researching for Cures" http://youtu.be/0zLAxjFny5Q )
UTSW's listing: http://www.utsouthwestern.edu/research/fact/detail.html?studyid=STU%20102013-007
…Note: Ipilimumab = BMS’s “Yervoy” (anti-CTLA-4) http://www.yervoy.com
...4-23-14: Bavi+Yervoy IST trial initiated: http://tinyurl.com/km7krcm