Avid Bioservices Inc (CDMO): PR 8-25-05: PPHM Licenses Anti-PSMA VTA...

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Thursday, 08/25/2005 12:58:25 PM

Thursday, August 25, 2005 12:58:25 PM

PR 8-25-05: PPHM Licenses Anti-PSMA VTA to MEDX

“Peregrine Pharmaceuticals Enters Into Licensing Agreement With Medarex to Develop Vascular Targeting Agents - Agreement Represents the Third Licensing Collaboration Under Peregrine's VTA Platform Technology”
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=749491
TUSTIN, CA, Aug 25 2005: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a biopharmaceutical company with a broad portfolio of products under development directed towards the treatment of cancer, viruses and other diseases, announced today that it has entered into a license agreement with Medarex, Inc. (Nasdaq: MEDX). Under the agreement, the company licensed to Medarex certain intellectual property rights under its broad Vascular Targeting Agent technology platform. This license allows Medarex to develop and commercialize their anti-PSMA monoclonal antibody conjugated to therapeutic agents and use the resulting conjugate for the treatment of a wide range of solid tumors.

Under the terms of the agreement, Peregrine Pharmaceuticals will receive an upfront payment and annual maintenance fees and may receive future payments based on the achievement of clinical milestones and a royalty on net sales if a product developed under the agreement is approved under the FDA. Further financial details were not disclosed.

"Peregrine's broad VTA intellectual property portfolio creates a number of opportunities for partnering and licensing as indicated by this licensing agreement and those completed earlier. These types of deals should add considerable value to the company as our partners move their VTA development programs forward," stated David Sherris, Ph.D., Peregrine's Head of Business Development. "We look forward to continuing discussions and entering into additional partnering arrangements with companies working in the vascular targeting area."

About Vascular Targeting Agents (VTAs):
The VTA technology is based on the concept that virtually all detectable tumors rely on a vascular network to obtain oxygen and nutrients. Peregrine's Vascular Targeting Agent technology platform is comprised of broad intellectual property rights covering products that selectively bind to components of tumor vasculature and deliver a therapeutic payload that causes damage to the tumor vasculature resulting in an avalanche of tumor cell death. VTAs utilize monoclonal antibodies and other targeting agents that recognize markers found on tumor blood vessels but not on normal blood vessels. VTAs could be very potent anti-tumor agents because they create two amplified processes that have a devastating effect on the tumor. The first process is the initiation of the coagulation cascade, which is a self-sustaining chain reaction in which a huge number of blood clotting molecules are generated, ultimately leading to complete occlusion of the tumor blood vessels within a matter of minutes. A second process occurs at the structural level where the blockage of a single capillary can lead to the destruction of thousands of tumor cells. As a result, small quantities of VTAs localized in the tumor's vascular system may cause an avalanche of tumor cell death. VTAs have the potential to be effective against a wide variety of solid tumors since: 1) the solid tumors studied to date in excess of two millimeters in size form a vascular network to enable the tumor to continue to grow, and 2) tumor vasculature markers are believed to be consistent across various tumor types.

About Peregrine Pharmaceuticals:
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a broad portfolio of products under development directed towards the treatment of cancer, viruses and other diseases. The company has opened patient enrollment in two separate clinical trials using Tarvacin for the treatment of solid cancers and for the treatment of Hepatitis C virus infection. In addition, Peregrine Pharmaceuticals is in the process of initiating patient enrollment in a Cotara clinical trial for the treatment of brain cancer. Peregrine Pharmaceuticals is also developing Vascular Targeting Agents, Anti-Angiogenesis, and Vasopermeation Enhancement Agents for the treatment of cancer and other diseases.

Peregrine Pharmaceuticals also has in-house expertise to develop and manufacture antibodies and recombinant proteins through its wholly-owned subsidiary, Avid Bioservices, Inc., (http://www.avidbio.com). Avid is engaged in providing contract manufacturing services and development of biologics for biopharmaceutical and biotechnology companies, including Peregrine.

Copies of PR’s / FWD-Looking .. . *snip*
Investor Inquiries:
Krista Mallory, Dir. of Investor Relations, 714-508-6000, info@peregrineinc.com
Media Inquiries:
Rachel Martin, Edelman Rachel.Martin@edelman.com
323-202-1031 / 323-893-9047

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Background on Anti-PSMA (mab E6):

Thorpe article in Sep2004 THE PROSTATE JOURNAL on Mab E6 (PSMA). Interesting "Funded By" section - The NIH pops up again.

Research Article:
“The Prostate” - 2004 Sep 15, 2004 – Vol. 61, Issue 1 , Pgs 1-11
Published Online: Mar5 2004 Received: Nov4 2003 Accepted: Dec23 2003

“Anti-tumor effects and lack of side effects in mice of an immunotoxin directed against human and mouse prostate-specific membrane antigen”
By: Xianming Huang, Mary Bennett, Philip E. Thorpe
Simmons Comprehensive Cancer Center, UT-SW Medical Center, Dallas; Dept. of Pharmacology, UT-SW Medical Center, Dallas
Dr. Philip E. Thorpe and Xianming Huang are consultants for Peregrine Pharmaceuticals

Funded by:
NIH; Grant Number: 1RO1CA74951-01, 5RO1CA54168-05
Peregrine Pharmaceuticals, Inc.
Gillson-Longenbaugh Foundation
Texas Advanced Technology Program

BACKGROUND: Prostate-specific membrane antigen (PSMA) is a transmembrane protein that is largely restricted to prostatic epithelial cells in humans and is strongly upregulated on prostatic carcinoma cells. It is also expressed on the endothelium of tumor vasculature in humans, but not on the vasculature of normal tissues. Expression of low levels of PSMA has also been found on non-vascular cells in several normal tissues, most prominently on the brain and kidney in humans. PSMA is an excellent candidate for targeting prostate cancer or targeting tumor vasculature of various solid tumors. The high potential clinical benefit of these agents has prompted the search for an animal model in which to assess the efficacy and safety of anti-PSMA monoclonal antibody (mAb)-based therapies.

METHODS: A rat monoclonal antibody, E6 that recognizes both mouse and human PSMA was generated using conventional hybridoma techniques. The antibody was characterized by enzyme-linked immunosorbent assay (ELISA), Western blot, and immunohistochemistry. An immunotoxin composed of E6, antibody and deglycosylated ricin A-chain (dgA) was prepared chemically. The anti-tumor effects of the immunotoxin were determined in vitro and in mice bearing subcutaneous LnCaP human prostate tumors, which express PSMA on the tumor cell surface.

RESULTS: E6 recognizes the extracellular domain of both human and mouse PSMA in ELISA, immunoblot and by immunohistochemistry. E6 strongly stained the vascular endothelium of tumors from humans but not from mice. E6 stained proximal tubules in mouse and human kidneys, and neurons in the mouse and human hippocampus but, unlike the human, did not detectably stain epithelial cells in mouse prostate or small intestine. An E6-dgA immunoconjugate strongly inhibited the growth of LnCaP tumor xenografts without causing apparent toxicity to the mice. Histological observation indicated that the anti-tumor effects were mediated through direct cytotoxic effects on the tumor cells.

CONCLUSIONS: We have generated and characterized a rat mAb (E6) that reacts specifically with both human and mouse PSMA and have demonstrated that an immunotoxin constructed from E6 is safe and effective against human prostatic carcinoma cells growing subcutaneously in nude mice.
PMID: 15287089 [PubMed - in process]
http://www3.interscience.wiley.com/cgi-bin/abstract/107632499/ABSTRACT
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_...