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September 23, 2009
New Family of Antigen-Adjuvant Fusion Proteins: Patent No. 7,588,930
NORTH BRUNSWICK, N.J.-- September 23, 2009 -- Please replace the release dated Sept. 21, 2009 with the following corrected version due to multiple revisions.
The corrected release reads:
ADVAXIS GRANTED NEW COMPOSITIONS AND METHODS PATENT
New Family of Antigen-Adjuvant Fusion Proteins: Patent No. 7,588,930
The United States Patent and Trademark Office (USPTO) has granted and issued Advaxis, Inc. (OTCBB: ADXS - News), the live, attenuated Listeria monocytogenes (Lm) vaccine company, patent 7,588,930 “Compositions and Methods for Enhancing Immunogenicity of Antigens.” This patent expands the Company’s intellectual property portfolio to cover another family of adjuvant proteins based upon the Lm protein Act-A.
Advaxis’ platform technology utilizes live, attenuated Lm to stimulate the immune system to attack cancer and infectious disease. Part of the technology uses highly immunogenic Lm proteins as adjuvants, which is done by bioengineering the bacterium to secrete the target antigen fused to a fragment of an Lm adjuvant protein in a single molecule. Advaxis owns 23 issued patents issued within its licenses portfolio and 22 pending patent applications. There are an additional 27 pending patent applications that the Company is currently negotiating the rights to with the University of Pennsylvania, the owner of these patents. There is no assurance that the parties will enter into this agreement, and that the Company will gain the rights to these additional 27 patents.
Currently, Advaxis is initiating clinical trials with a strain of Lm that secretes Listeriolysin-O (LLO) fused to the tumor-causing antigen HPV-16 E7. Both LLO and Act-A generate strong innate immune responses. LLO enables the Lm bacterium to escape digestion and infect antigen presenting cells; whereby, the cells then “tell” the immune system what to attack. Act-A enables Lm to become motile and infect adjacent cells. Since both of these proteins facilitate infection our bodies have evolved strong immune responses against them. By using these highly immunogenic protein fragments, the vaccines have a much greater therapeutic effect. Advaxis has engaged Numoda Corporation, the Company's contract research organization, to initiate the preliminary work necessary to begin two clinical trials: one in advanced cervix cancer in India and one in cervical intraepithelial neoplasia (CIN) in the United States. We anticipate that if we are successful in obtaining the required funding, we can begin the recruitment for these trials in late October or November 2009.
The addition of this new family of antigen-adjuvant proteins, based upon Act-A, enables the development of new vaccines with additional properties not previously possible. For example, Advaxis has filed a patent on a new strain of Lm vaccine that delivers two simultaneous and independent antigen-adjuvant proteins at the same time. And, Advaxis recently announced the receipt of a $210,000 grant from the National Institutes of Health to support this research.
About the Company
Based in North Brunswick, New Jersey, Advaxis is developing proprietary Listeria monocytogenes (Lm) cancer vaccines based on technology developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania and chairperson of Advaxis’ scientific advisory board. Advaxis is developing attenuated live Lm vaccines that deliver engineered tumor antigens, which stimulate multiple simultaneous immunological mechanisms to fight cancer.
In a recent Advaxis Phase I clinical trial, a live Lm vaccine directed against the tumor-associated antigen HPV-16-E7 was safely administered to fifteen (15) women with advanced metastatic cancer of the cervix. Although this first trial of an Lm vaccine in humans was not designed or powered to prove efficacy, Advaxis believes an efficacy signal was observed that will be further explored in two (2) planned Phase II trials in the US and India in cervical cancer and its predecessor condition, cervical intraepithelial neoplasia (CIN). Advaxis now has nine (9) distinct cancer fighting constructs in various stages of development, both directly and with academic collaborators. For further information on the Company, please visit: www.advaxis.com.
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.