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U.S. Patent and Trademark Office Issues Patent for Live Listeria HER2/neu Immunotherapy


Friday, September 10, 2010

North Brunswick, NJ -- The U.S. Patent and Trademark Office has issued to Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes(Listeria) immunotherapy company, patent number 7,784,729 titled “Methods and Compositions for Immunotherapy of Cancer,” based upon patent application 10/949,667.

This patent extends the company’s proprietary technology to include fusion proteins using the company’s proprietary truncated listeriolysin O (tLLO) in combination with the proprietary HER2/neu fragments previously approved by the USPTO, as either genomically modified or plasmid based Listeria vaccines for the treatment of breast and other cancers. This broadens Advaxis’ patent position and extends it in time with additional compositions of matter, uses and methods.

“Our patent strategy involves many interlocking elements,” said Advaxis EVP of Science and Operations Dr. John Rothman. “This patent work performed by Dr. Yvonne Paterson and Dr. Reshma Singh, who has recently joined the company, provides an entirely new way of utilizing effective portions of the antigen HER2/neu and is the basis for the vaccine we are currently preparing for clinical trials next year.”

About The Science

Advaxis has advanced the use of live, attenuated Listeria as a cancer vector in Advaxis laboratories by using these HER2/neu fragments to create a chimeric form of a HER2/neu cancer immunotherapeutic (ADXS31-164). This new form of HER2/neu contains only those fragments of the antigen that are the most immuno-reactive portions of the molecule excluding the less antigenic portions of the molecule.

The collaboration between Advaxis and the University of Pennsylvania (UPenn) was published earlier this year (Shahabi, et al 2010. Cancer Gene Therapy, epub. 8/20 ahead of print and Seavey, et al 2009 Clin Cancer Res; 15(3): 924-32). In this work, it was shown that a live, attenuated Listeria vaccine using LLO fused to Advaxis’ chimeric human HER2 antigen (chHer2) was able to significantly extend survival in transgenic animals bioengineered to be born with the HER2 antigen and thus develop tumors spontaneously. By using a chimeric antigen with 17 distinct antigenic targets (epitopes) in a single vaccine, the authors reported that escape mutations, which would allow tumors to escape immune attack did not occur. Over 20% of the transgenic animals treated with ADXS31-164 did not develop tumors across a 52-week observation period. All of the control animals had expired by week 33. Significant increases in survival were demonstrated in different models due to therapeutic effects upon brain cancers and pulmonary metastases.

This is the first report of a therapy being able to prevent the generation of spontaneous tumors in HER2 transgenic animals for a year.

About Advaxis’ Proprietary Technology

Advaxis technology is based upon the ability of antigen-adjuvant fusion proteins to stimulate a therapeutic immune response against cancer and infectious disease; especially when synthesized and secreted by live, attenuated Listeria. The company’s intellectual property portfolio consists of over 70 issued patents and pending applications that protect compositions of matter, methods of manufacture and methods of use of various strains of live Listeria created for human use. The portfolio also includes compositions, methods and uses of different families of antigen-adjuvant fusion proteins made and secreted by live Listeria or administered independent of Listeria. These include fusion proteins based upon LLO, ActA and other PEST containing proteins. The number of proprietary Listeria strains and fusion protein families enables Advaxis to construct a large number of different vaccines to treat cancer or infectious disease based upon the antigen(s) used and the disease to be treated. The commercial utility of this portfolio is supported by the successful defense of our intellectual property in patent litigation, and by a growing body of positive clinical and preclinical results.

About Advaxis, Inc.

Advaxis is a biotechnology company developing proprietary, live, attenuated Listeria monocytogenes (Listeria) vaccines that deliver engineered tumor antigens, which stimulate multiple, simultaneous immunological mechanisms to fight cancer. Today, the Company has nine (9) distinct, cancer-fighting constructs in various stages of development, directly and through strategic collaborations with such recognized sites of excellence as the City of Hope, the Roswell Park Cancer Institute, the National Cancer Institute, the University of Pittsburgh, Cancer Research – UK and the Department of Homeland Security. Advaxis’ technology was developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania and chairperson of Advaxis’ scientific advisory board.

Forward-Looking Statements

Certain statements contained in this press release are forward-looking statements that involve risks and uncertainties. The statements contained herein that are not purely historical are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements deal with the Company’s current plans, intentions, beliefs and expectations and statements of future economic performance. Forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results in future periods to differ materially from what is currently anticipated. Factors that could cause or contribute to such differences include those discussed from time to time in reports filed by the Company with the Securities and Exchange Commission. The Company cannot guarantee its future results, levels of activity, performance or achievements.



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