Avid Bioservices Inc (CDMO)

[entdoc]

PPHM has FULLY Humanized Bavi in the wings. Also, PPHM has a better Avastin MAB in human trials in Russia. PPHM Cotara MAb HAS demonstrated superior survival to SOC in worst brain cancer, glioblastoma multiforme. We'll be visiting several PPHM pipeline items lest you think Bavi is PPHM sole winner:
Classic CJGaddy post; April 22, 2009
“Data Presented at AACR Annual Meeting Show Anti-Tumor Activity of Peregrine's Fully Human Anti-PS Antibody [PGN635, aka 1N11] in Prostate Cancer Model.
• Preclinical Results Further Validate Significant Anti-Tumor Potential of Fully Human Anti-PS Antibodies and Expand the Company's PS-Targeting Platform
• Treatment with Mouse Equivalent to the Human Antibody Inhibited Tumor Growth in a Prostate Cancer Model by More than 90%”
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=378985

DENVER & TUSTIN, April 22, 2009: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and serious virus infections, today announced that preclinical data presented during the AACR 100th Annual Meeting 2009 shows that one of its fully human phosphatidylserine (PS)-targeting antibodies demonstrated encouraging signs of efficacy in a preclinical model of prostate cancer. These positive new data validate the anti-tumor potential of this human anti-PS antibody, which is similar to Peregrine's lead clinical stage antibody bavituximab and extends Peregrine's anti-PS antibody pipeline. Bavituximab is in Phase II clinical trials for the treatment of advanced breast cancer and non-small cell lung cancer.

Peregrine's PS-targeting antibodies bind to the cellular membrane component PS that is usually located inside cells, but which becomes exposed on the external surface of the cells that line the blood vessels of tumors (the tumor vascular endothelium), creating a specific target for anti-cancer treatments. By binding to PS, the antibodies are believed to help mobilize the body's immune system to destroy the tumor and the tumor blood vessels.

In today's presentation, researchers from UT Southwestern Medical Center in Dallas and Affitech A/S reported that similar to bavituximab, the human antibody PGN635 [aka 1N11] targets and binds specifically to the tumor vascular endothelium(1). Treatment with androgen deprivation therapy or docetaxel substantially increased the percentage of tumor blood vessels with PGN635 binding.

The researchers also reported that in a mouse model of prostate cancer, treatment with a mouse-equivalent antibody of PGN635 significantly retarded the growth of tumors by more than 90%. These positive results reinforce the findings of previous preclinical studies with Peregrine's anti-PS antibodies that showed promising anti-tumor activity in combination regimens in models of prostate cancer.

"As our understanding of PS-targeting antibodies continues to increase, the availability of anti-PS antibodies that vary in their mode of binding or in their specific immunomodulatory activity broadens the potential clinical applications of our anti-PS technology platform," said Steven W. King, president and CEO of Peregrine. "Our collaboration with Affitech to generate fully human anti-PS antibodies has produced a number of antibodies with varying characteristics. We look forward to continuing to pursue both internal efforts and external collaborations to further explore the clinical potential of these promising development candidates."

The fully human PS-targeting antibody in this study was developed through Peregrine's collaboration with Affitech A/S. The studies were supported in part by a grant and a post-doctoral fellowship from the U.S. Department of Defense.

Peregrine's lead PS-targeting antibody bavituximab is currently in 2 separate Phase II combination therapy trials for the treatment of advanced breast cancer, one in combination with docetaxel and the other in combination with carboplatin & paclitaxel. A third Phase II trial in combination with carboplatin & paclitaxel is currently ongoing for the treatment of non-small cell lung cancer. A Phase I bavituximab monotherapy trial in advanced solid cancers is also continuing.

(1) Yi Yin, Anita Kavlie, Philip E. Thorpe. UTSW-MC/Dallas, Affitech AS, Oslo, Norway.
“Fully human anti-phosphatidylserine antibody inhibits the growth of prostate cancer in mice”
In: Proceedings of the 100th Annual Meeting of the American Association for Cancer Research; 2009 Apr 18-22; Denver, CO. Philadelphia
AACR; 2009. Abstract nr 5463

ABOUT PEREGRINE PHARMACEUTICALS
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and serious virus infections. The company is pursuing 3 separate clinical programs in cancer and hepatitis C virus infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.

Safe Harbor *snip*

Contacts: GendeLLindheim BioCom Partners
Investors: 800-987-8256, [e-mail]
Media: Barbara Lindheim, 212-918-4650
*end*

= = = = = = = = = AACR’09 4-20-09:
#5463: Fully-Human Anti-PS 1N11=PGN635 “Inhibits the Growth of Prostate Cancer in Mice”

AACR 2009 Abstract #5463 4-22-09 8am-12pm http://tinyurl.com/cqv9az
Poster Session: Antibody Technologies
”Fully Human Anti-Phosphatidylserine Antibody [1N11=PGN635] Inhibits the Growth of Prostate Cancer in Mice”
Yi Yin, Anita Kavlie [Senior Scientist, Affitech], Philip E. Thorpe
UTSW-MC/Dallas, Affitech AS, Oslo, Norway
ABSTRACT: Phosphatidylserine (PS), a phospholipid normally residing in the inside leaflet of the plasma membrane, becomes exposed on tumor vascular endothelial cells in response to oxidative stresses in the tumor microenvironment. Anti-PS antibodies have been developed. Binding of anti-PS antibodies on the tumor endothelial cells recruits immune cells to destroy tumor vasculature. The antibodies also enhance anti-tumor immunity by blocking the immunosuppressive action of PS. A chimeric anti-PS antibody, bavituximab, is being used in combination with chemotherapy to treat patients with metastatic breast cancer in Phase II trials. We developed the fully human anti-PS antibody 1N11 [aka PGN635 = Fully-Human Bavituximab]. Being fully human, 1N11 is less likely to evoke an anti-antibody response in clinic. The antibody was tested for cross reactivity profiles by ELISA, and its ability to localize to tumor vessels by immunofluoresence staining. 1N11 binds to PS through beta-2-glycoprotein 1 (B2GP1) in the same manner as bavituximab. It recognizes human and mouse B2GP1 with equal affinity, whereas bavituximab is selective for human B2GP1. 1N11 localized specifically to tumor vascular endothelium after injection into severe combined immunodeficient mice bearing LNCaP and PC3 tumors. Treatment with castration increased the percentage of tumor vessels with 1N11 binding from 20% to 80% in mice bearing LNCaP xenografts. Treatment with docetaxel increased the localization of 1N11 on tumor vessels from 30 to 65% in mice bearing PC3 xenografts. To evaluate therapeutic efficacy of 1N11, we created a mouse IgG2a chimeric version, called mch1N11, to ensure compatibility with mouse effector cells and complement. Treatment with mch1N11 retarded the growth of orthotopic PC3 tumors by more than 90% as judged by bioluminescent imaging. Toxicity to the mice was not observed. These results provide the rationale for using 1N11 alone, or in combination with androgen deprivation therapy or chemotherapy to treat prostate cancer patients.

= = = = = = = BACKGROUND ON 1N11=PGN635=FH-BAVI:
10-23-08 Affitech’s Dr. Anita Kavlie presents 1N11/PGN635(FH-Bavi) & R84/PGN311(2C3) at ANTIBODIES-EUR’08: http://tinyurl.com/4w9qba
4-15-08: AACR2008 #4079, Bavi/PGN635(fully-human) Induces ADCC http://tinyurl.com/6ql5nf
…Steven King, ”by blocking PS and its anti-inflammatory signals, our anti-PS antibodies unleash powerful pro-inflammatory effects that enhance their anti-cancer effectiveness.”
...5-6-08 Affitech's followup PR on PGN635: http://tinyurl.com/3h26wk

= = = = = = = = = = =
###THREE DOD GRANTS TO THORPE/MASON (UTSW) FOR BAVI/AC PRE-CLINICAL STUDIES:

4-25-06 3rd DOD Grant W81XWH-06-1-0475: $460k, Mason, Bavi+Rad vs. Breast Cancer http://tinyurl.com/v9hye
Dr. Mason: "Since bavituximab's unique target is expressed on blood vessels in tumors but not in normal tissues, it may have both safety & efficacy advantages compared to other antibodies. We are eager to assess the utility of a bavituximab radioimmunoconjugate for the identification and treatment of metastatic breast disease." CEO S.King, "Data from this project could open the door for use of Bavituximab as an agent to identity, measure and ultimately destroy the metastases that kill most cancer patients."
...Dr. Mason’s 6-2008 Bavi+Rad poster at DOD ‘Era of Hope’ Meeting (1-pg PDF): http://tinyurl.com/5e9r37
...3-1-08 Thorpe/Mason C.C.R. (AACR) article on Arsenic-labeled Bavi for Imaging: http://tinyurl.com/32jbfl
...Dr. Mason’s 4-2007 Ann.Rept #1 (18pg PDF) for DOD Grant3: http://tinyurl.com/2jz3rp
...Dr. Mason’s 8-2006 poster at SMI-2006, “Optical Imaging of Exposed PS” (1-pg PDF): http://tinyurl.com/ys2afj
...Dr. Ralph Mason's 2-2006 Lecture Video w/6 mins. on Bavi: http://tinyurl.com/yqxngq

1-18-06 2nd DOD Grant W81XWH-06-1-0149: $585k, Mason, Bavi+Chemo vs. Prostate Cancer http://tinyurl.com/y683vn
Dr. Mason: "This new prostate cancer grant, which brings together the expertise of several disciplines at UT-SW, will employ advanced techniques such as MRI tumor oximetry to measure dynamic changes in the tumors. We expect that the findings of these studies will be directly applicable to the design of Tarvacin clin. trials for prostate cancer."
...Dr. Mason’s 12-2007 Ann.Rept #2 (23pg PDF) for DOD Grant2: http://tinyurl.com/3j9y6u
...Dr. Mason’s 1-2007 Ann.Rept #1 (16pg PDF) for DOD Grant2: http://tinyurl.com/2jz3rp
...Dr. Mason’s 9-2007 poster (PDF) at DOD/IMPACT Conf: http://tinyurl.com/2mql39 & http://tinyurl.com/2jalhs

11-3-05 1st DOD Grant PC050301: $583k, Thorpe, Bavi+Chemo vs. Prostate Cancer http://tinyurl.com/wcwl7
Dr. Thorpe: "This DOD grant will enable us to further investigate current evidence that Bavi in combo with chemo strongly inhibits tumor growth in pre-clin. models of prostate cancer. Receipt of this peer-reviewed DOD grant signals the growing scientific interest & acceptance of the potential therapeutic value of our VTAs"