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Re: cjgaddy post# 93976

Saturday, 08/17/2013 8:58:03 AM

Saturday, August 17, 2013 8:58:03 AM

Post# of 346000
PPHM/VP Dr. J.Hutchins’ 8-14-13 Presentation on the Immune-Stimulatory Moa of PS-targeting antibodies like Bavituximab at CHI’s “Immunotherapies Congress” conf. in Boston. See screen-shots of Dr. Hutchins’ 23-Slide presentation, followed at the bottom by slides from CEO Steve King’s 8-13-13 Wedbush Life Sciences Conf. in NYC, many of which also highlighted the immuno-therapeutic moa of Peregrine’s PS-Targeting antibodies.

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8-14-13 PR: Bavituximab's Mechanism of Action Highlighted at Immunomodulatory Therapeutic Antibodies for Cancer Conference
• Presentation Reviews Bavituximab's and Docetaxel's Compatible Immune-Stimulating Properties Further Supporting Initiation of Phase III Trial in Second-Line NSCLC by Year-End
• Proof-of-Concept Studies Combining Bavituximab With Other Immunotherapy Agents Underway
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=785223

TUSTIN, 8/14/13: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) today announced the presentation of preclinical data and ongoing drug development activities highlighting the immune-stimulatory mechanism of action of phosphatidylserine (PS)-targeting antibodies, such as the company's lead drug candidate bavituximab. Data from this presentation showed that PS-targeting antibodies block a primary upstream immune checkpoint, thus inhibiting PS from engaging its natural receptors on immune cells, resulting in multiple downstream immunostimulatory effects. Bavituximab is the company's lead PS-targeting investigational product and is currently being evaluated in several solid tumor indications with the initiation of a Phase III trial in second-line non-small cell lung cancer (NSCLC) anticipated by calendar year-end. This presentation was made today at Cambridge Healthtech Institute's Immunotherapies Congress in Boston, Massachusetts.

The presentation titled: "Engagement of Phosphatidylserine (PS) by PS-targeting Antibodies Blocks an Upstream Immunosuppressive Checkpoint in the Tumor Microenvironment; Inducing Multiple Downstream Anti-tumor Response Mechanisms" detailed the role of exposed PS as an important upstream immune checkpoint. Administration of PS-targeting antibodies was shown to mediate pro-inflammatory cellular and cytokine responses that convert immunosuppressive cells known as myeloid derived suppressor cells (MDSCs) into tumor fighting (M1) macrophages. PS-targeting antibodies also facilitated the maturation of dendritic cells capable of presenting tumor antigens to T-cells to facilitate tumor-specific cytotoxicity. These multiple anti-tumor effects were further shown to occur without the side-effects associated with systemic immune activation. This was presented by Jeff T. Hutchins, Ph.D., VP, Pre-Clinical Research of Peregrine Pharmaceuticals.

"We are pleased to be presenting this compelling data to investigators of the oncology and immunology community as these results clearly demonstrate the immune-stimulatory effects of bavituximab," said Dr. Hutchins. "These data have shown the breadth of bavituximab's potential benefits as an immunotherapy and have led to the implementation of a supplemental clinical development strategy that explores the synergies between bavituximab and other immunotherapeutic drugs. The first part of this plan began in June with the initiation of several proof-of-concept preclinical studies constructed to read out in the next couple of months in order to assist us in designing a clinical trial examining a combination of bavituximab with an approved immunotherapy. In addition, we are leveraging data from our ongoing investigator-sponsored clinical trials to garner additional insight to support our development activities. We believe that this immune-stimulatory data shows that bavituximab has the potential to be combined with multiple downstream immunotherapies, such as Anti-PD-1, Anti-PDL-1, Anti-CTLA-4, IL-2, or PAP-GMCSF, to provide increased therapeutic benefit."

In addition, Dr. Hutchins reviewed the supporting rationale for the combination use of bavituximab and the chemotherapeutic agent docetaxel. Citing the synergistic immunotherapeutic mechanisms of each of bavituximab and docetaxel, the presentation summarized the promising data generated to date that further validate this combination therapy and provide additional scientific rationale that supports advancing this program into Phase III.

"These data clarify our understanding of bavituximab, put recent clinical results into greater perspective and allow us to supplement our current drug development strategy in order to enhance bavituximab's therapeutic potential," said Joseph Shan, VP, Clinical & Regulatory Affairs of Peregrine. "As a result of the recent insights into bavituximab's mechanism of action, we are actively engaged with key opinion leaders in the field of immunology to assist us as we advance this concurrent immune-stimulatory-focused clinical program."

Slides from Dr. Hutchins' presentation today are available at http://ir.peregrineinc.com/events.cfm .
[ PDF: http://www.peregrineinc.com/images/stories/pdfs/chi_2013.pdf **SEE IMAGES BELOW**]

About Bavituximab: A Targeted Immunotherapy
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of cells that line tumor blood vessels, causing the tumor to evade immune detection. Bavituximab targets PS and activates the maturation of dendritic cells and cancer-fighting (M1) macrophages leading to the development of cytotoxic T-cells that fight solid tumors through blocking this immunosuppressive PS signal. Bavituximab is the company's lead PS-targeting investigational product and is currently being evaluated in several solid tumor indications, including non-small cell lung cancer, breast cancer, liver cancer and rectal cancer.

About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead immunotherapy candidate bavituximab and novel brain cancer agent Cotara®. 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. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
Contact: Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals (800) 987-8256 info@peregrineinc.com

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Aug 13–15 2013: “CHI’s The Immunotherapies Congress”, Boston
Co-located with the 8th Annual “ImVacS” (Immunotherapeutics & Vaccine Summit) http://www.imvacs.com
2 INAUGURAL SUB-CONFERENCES:
• Aug13-14: Emerging Cancer Immunotherapies & Vaccines
• Aug14-15: Immunomodulatory Therapeutic Antibodies for Cancer <=PPHM’s Dr. Hutchins Presenting
CHI = Cambridge Healthtech Inst. http://www.healthtech.com
Conf. website: http://www.immunotherapiescongress.com
http://www.immunotherapiescongress.com/Immunomodulatory-Antibodies-Cancer

”Recent advances in cancer immunotherapy have turned researcher's attentions to new therapeutic strategies focused on improved specificity, control of key checkpoints in immune response, the identification of new biomarkers and novel ways of combining therapies for maximum effect. The 2-conf. Immunotherapies Congress offers an exciting opportunity to learn how these strategies are being translated into the next generation of cancer immunotherapeutic drug products.”
“Immunomodulatory Therapeutic Antibodies for Cancer” showcases the exciting wave of checkpoint blockades such as anti-PD-1 & anti-CTLA-4 now in clinical development – and explores considerations of trial design, drug safety, and biomarker discovery that will influence their application in patients.
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OVERVIEW: ”The recent approval of BMS's Yervoy (ipilumumab) and a succession of related programs advancing through clinical trials has generated increased interest in the development of antibody-based immunomodulators for cancer. Immunomodulatory Therapeutic Antibodies for Cancer will provide updates of clinical stage programs, and examine how these novel therapeutics influence trial design and the selection of clinical endpoints. Strategies for immune modulation that are most appropriate for targeting with antibodies will be considered, along with where combination regimens and new therapeutic formats can be effectively applied.”
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PEREGRINE (Dr. Hutchins) – Aug. 14 3:00pm:
Session: Immune Checkpoint Blockades
Presentation: “Engagement of Phosphatidylserine (PS) by PS-targeting Antibodies Blocks an Upstream Immunosuppressive Checkpoint in the Tumor Microenvironment; Inducing Multiple Downstream Anti-tumor Response Mechanisms”
Jeffrey T. Hutchins, PhD, VP, Preclinical Research, Peregrine Pharmaceuticals
ABSTRACT:
The hallmark of apoptosis, phosphatidylserine (PS) exposure promotes non-inflammatory phagocytosis of dying native cells. This signaling pathway appears to be exploited by tumors resulting in the suppression of both innate and adaptive tumor immune responses. Administration of PS-targeting antibodies mediates pro-inflammatory cellular and cytokine responses that reverse this immunosuppressive checkpoint without the side-effects associated with systemic immune activation. Bavituximab is a late-stage clinical PS-targeting antibody that has demonstrated promising signs of anti-tumor activity and extended survival in patients with NSCLC and breast cancer.
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Jeff T. Hutchins, VP, Preclinical Research - Dr. Hutchins was appointed VP of Preclinical Research in Sept. 2012. Prior to joining Peregrine, Jeff served for the last 5 of 11 years as VP, Pre-clinical Dev. at Inhibitex Inc, which was recently acquired by Bristol Meyers Squibb. . .
http://www.peregrineinc.com/about-us/management-team.html

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IMAGES of Dr. Jeff Hutchins 8-14-13 CHI’s “The Immunotherapies Congress” Slideshow (PDF - 23 slides):
(PPHM VP Dr. J.Hutchins presented MOA of PS-Targeting Mabs in 'Immune Checkpoint Blockades' session)
PDF Link: http://www.peregrineinc.com/images/stories/pdfs/chi_2013.pdf














































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PS-TARGETING SCIENCE: "Evolution has favored pathogenesis that resembles apoptosis."
Dr. Judah Folkman: ”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 & Cotara Technologies: http://www.peregrineinc.com/technology/overview.html
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
BAVI MOA: 5-26-11 Dr.Thorpe's keynoter at Recombinant-Mabs/Barcelona http://tinyurl.com/3klpodc & http://tinyurl.com/3m33h33
BAVI MOA: 4-2010 Thrombosis Research article (Dr.Thorpe) http://tinyurl.com/9reso7s
BAVI MOA: See http://www.peregrineinc.com/technology/bavituximab-oncology/recent-data.html
FTM's 12-2012 post giving links to 46 Cancer & Immunology journals & websites: http://tinyurl.com/agwn2o8
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SLIDES FROM CEO S.KING’S 8-13-13 WEDBUSH TALK (NYC)
=> See Slides 5-14, 17, and 25-26 on Bavi’s Immune-Stimulating MOA & Potential…

CEO Steven King’s 26 min. Presentation – Wedbush/NYC 8-13-2013
Aug13, 2013 - Wedbush Life Sciences Mgt. Access Conf., NYC
8-13-2013 WEBCAST Replay: http://ir.peregrineinc.com/events.cfm - REPLAY direct link: http://wsw.com/webcast/wedbush25/PPHM
FULL TRANSCRIPT:
http://www.earningsimpact.com/Transcript/82836/PPHM/Peregrine-Pharmaceuticals---Wedbush-2013-Life-Sciences-Management-Access-Conference






































































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Wedbush Q&A – S.King responding to the question, “When are you going to partner?”…
SK 8-13-13: “We have very active partnering discussions around our 2 lead programs. Our stated goal is to ideally have a partner for both programs, Cotara, and really with all the activities going on around Bavituximab, it’s going to be necessary. We’re in a position to run a Phase III for Bavituximab and to run that study by ourselves if a partner doesn’t come on board or if the right terms aren’t on the table. Having said that, our stated goal is to identify primarily ex-U.S. partners; we’d like to at least maintain co-promotional rights here in the U.S. and there’s some significant upside at the end of the development road here. So, you know, they all have their own tone & tenor, and we’re very actively working toward it.”
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