Avid Bioservices Inc (CDMO)

[cjgaddy]

1-6-16: Peregrine enters Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN), via a $2mm research grant to NCCN's Oncology Research Program (ORP). Will “significantly expand our clinical evaluation of bavituximab and augment Peregrine's internal IST program” at “26 of the world's leading cancer centers”.

1-6-16: Peregrine Pharmaceuticals and National Comprehensive Cancer Network (NCCN) Form Clinical Collaboration to Evaluate Novel Cancer Treatment Combinations With Bavituximab
• NCCN Alliance Includes 26 Leading Cancer Centers and World-Class Thought Leaders on Innovative Cancer Combination Therapies
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=949024

TUSTIN, Jan. 6, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced a new research collaboration with the National Comprehensive Cancer Network (NCCN) [ http://www.nccn.org ] to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors. NCCN, a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.

Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine's PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight cancer. According to Peregrine, a broad set of preclinical and translational data has been assembled that supports the ability of bavituximab to improve the therapeutic activity of a range of cancer treatments, from traditional approaches, such as chemotherapy and radiation, to novel immuno-oncology agents such as checkpoint inhibitors.

"This collaboration with NCCN will allow us to significantly expand our clinical evaluation of bavituximab and augment Peregrine's internal investigator sponsored trial (IST) program," said Steven W. King, President and CEO of Peregrine. "Importantly, NCCN shares our strong research interest in evaluating unique bavituximab combination therapies for the treatment of cancer, and the group's oversight of the program will allow for the conducting of many more studies than would have been otherwise possible."

"NCCN is very pleased to collaborate with Peregrine Pharmaceuticals on their first-in-class novel targeted monoclonal antibody, bavituximab," said Robert C. Young, MD, Interim Vice President, ORP, NCCN. "We look forward to a productive interaction in both clinical and pre-clinical studies undertaken at the NCCN Member Institutions."

Peregrine expects results from this collaboration to further support the ongoing development of bavituximab as a key component of various combination cancer treatments. Bavituximab is currently being evaluated in combination with docetaxel (chemotherapy) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in the ongoing Phase III SUNRISE trial. In addition, as part of its recently formed collaboration with AstraZeneca, Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in patients with previously treated squamous or non-squamous NSCLC. The company will also be evaluating bavituximab with chemotherapy combinations in HER2-negative breast cancer.

About Bavituximab: A Targeted Investigational Immunotherapy
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab blocks PS, which is believed to remove this immunosuppressive signal and send an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in robust anti-tumor immune responses.

About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials focused on the treatment of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of previously treated non-small cell lung cancer (the "SUNRISE trial") along with several ongoing and planned company-sponsored trials evaluating other treatment combinations and additional oncology indications. 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 .

About the National Comprehensive Cancer Network [ http://www.nccn.org ]
The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 26 of the nation's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.

The NCCN Member Institutions are: Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.

Clinicians, visit http://NCCN.org . Patients and caregivers, visit http://NCCN.org/patients .
Safe Harbor *snip*
• Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 [e-mail]
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 [e-mail]
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 [e-mail]

= = = = = = = = =NCCN's 1-6-16 PR:
1-6-16: NCCN Awarded $2 Million in Research Funding from Peregrine Pharmaceuticals to Study Bavituximab in Various Cancers
• The NCCN Oncology Research Program (ORP) was awarded a $2-million grant from Peregrine Pharmaceuticals, Inc. to facilitate studies of bavituximab in various cancers.
http://www.nccn.org/about/news/newsinfo.aspx?NewsID=565

FORT WASHINGTON, PA —The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) has been awarded a $2-million grant from Peregrine Pharmaceuticals, Inc. to study bavituximab, a first-in-class treatment approach for various cancers.

“NCCN is very pleased to collaborate with Peregrine Pharmaceuticals on their first-in-class novel targeted monoclonal antibody, bavituximab,” said Robert C. Young, MD, Interim Vice President, ORP, NCCN. “We look forward to a productive interaction in both clinical and pre-clinical studies undertaken at the NCCN Member Institutions.”

“This collaboration with NCCN will allow us to significantly expand our clinical evaluation of bavituximab and augment Peregrine’s internal investigator sponsored trial (IST) program,” said Steven W. King, President and CEO, Peregrine. “Importantly, NCCN shares our strong research interest in evaluating unique bavituximab combination therapies for the treatment of cancer, and the group’s oversight of the program will allow for the conducting of many more studies than would have been otherwise possible.”

Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine’s PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight canceri. According to Peregrine, a broad set of pre-clinical and translational data has been assembled that supports the ability of bavituximab to improve the therapeutic activity of a range of cancer treatments, from traditional approaches, such as chemotherapy and radiation, to novel immuno-oncology agents such as checkpoint inhibitors.

The first phase of the program will involve the establishment of an NCCN Bavituximab Request for Proposals Development Team to evaluate existing data and to discuss and define the data and type of studies necessary to further characterize the safety and clinical effectiveness of bavituximab.

The NCCN ORP draws on the expertise of the investigators of the NCCN Member Institutions and NCCN Affiliate Research Consortium (ARC) to facilitate all phases of clinical research. This research is made possible by collaborations with pharmaceutical and biotechnology companies in order to advance therapeutic options for patients with cancer.

The NCCN ORP will utilize the grant from Peregrine Pharmaceuticals to support investigator-initiated clinical and correlative studies at NCCN Member Institutions and their affiliate community hospitals for bavituximab. To date, this successful research model has received approximately $58 million in research grants and supported more than 132 studies that have produced a number of publications in peer-reviewed journals.

To learn more about the NCCN ORP and ongoing clinical trials, visit http://NCCN.org/ORP .
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