Advaxis and UC San Francisco to Evaluate Cancer Immunotherapy Constructs in Prostate Cancer

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PRINCETON, N.J., March 17, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing the next generation of cancer immunotherapies, announced that it has signed an agreement with the University of California, San Francisco (UCSF), under which Lawrence Fong, M.D., Professor in the Department of Medicine and principal investigator of the studies at UCSF, will evaluate several new immunotherapy constructs, in addition to ADXS-PSA, each built on the Advaxis proprietary technology. Data generated from this agreement will demonstrate the combination of the unique Advaxis immunotherapy platform, which generates both tumor fighting T cells and reduces tumor protection inside the tumor microenvironment, with targets that have already been shown to be important in effective immunotherapies for prostate cancer.

ADXS-PSA is an immunotherapy that is designed to target the PSA antigen associated with prostate cancer. By incorporating PSA into the Advaxis live, attenuated vector, Advaxis intends to deliver the PSA antigen, fused to the powerful immunostimulant LLO, directly inside antigen presenting cells that are capable of driving a cellular immune response to PSA expressing cells. The Advaxis approach is also designed to inhibit the Treg and MDSC cells that contribute to immunologic tolerance of prostate cancer.

Dr. Lawrence Fong is a medical oncologist in San Francisco, California and is affiliated with UCSF Medical Center. Dr. Fong's laboratory is dedicated to understanding the interaction between the immune system and cancer. Dr. Fong and his team have identified several tumor targets associated with clinical responses in immunotherapy studies for prostate cancer and will collaborate with Advaxis scientists to adapt these targets to the Advaxis immunotherapy platform. The constructs may also have activity against other cancers, which could be explored as the prostate cancer program develops further.

Dr. Fong commented, "This is an exciting opportunity to work with novel immunotherapies and enhance our understanding of the interaction between the immune system and prostate cancer. We look forward to studying this treatment in combination with some of UCSF's proprietary tumor antigens."

"ADXS-PSA is Advaxis's first generation prostate cancer immunotherapy construct which we plan to advance to Phase 1 clinical trials in the first half of 2014," commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. "We are pleased to be working with Dr. Fong at UCSF to lay the groundwork for a second generation of effective immunotherapies for prostate and, potentially, other cancers. This collaboration will further advance our prostate cancer program and demonstrates our commitment to developing immunotherapies for the 1 in 7 men in the U.S. who will be diagnosed with prostate cancer."

According to the American Cancer Society, about 233,000 new cases of prostate cancer were diagnosed in 2013 and about 29,480 men will die from the disease. Prostate cancer is the second leading cause of cancer death in American men, behind only lung cancer.

About the Laboratory of Lawrence Fong, M.D.

Dr. Lawrence Fong is a medical oncologist in San Francisco, California and is affiliated with UCSF Medical Center. Dr. Fong's laboratory is dedicated to understanding the interaction between the immune system and cancer. Characterizing and quantifying the immune response to antigens in different disease states will be crucial to developing potential vaccine and immunotherapeutic strategies. Currently, the research program is divided into three distinct but related areas of interest. These include studying dendritic cell biology, exploring approaches to break tolerance against self-antigens, and characterizing effector and memory T cells following tumor immunotherapy.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing the next generation of cancer immunotherapies. Advaxis's immunotherapies are based on a novel platform technology using live, attenuated bacteria to stimulate the immune system to selectively target cancer cells while reducing tumor defenses.

ADXS-HPV, Advaxis's lead immunotherapy for the treatment of HPV-associated cancers, has demonstrated improved survival and objective tumor responses in a Phase 2 trial in 110 patients with recurrent cervical cancer. Advaxis is now planning the registrational program for ADXS-HPV. ADXS-HPV is also being evaluated in other HPV-associated cancers including a Phase 2 in advanced cervical cancer, a Phase 1/2 in head and neck cancer, and a Phase 1/2 in anal cancer. ADXS-HPV has orphan drug status for both anal and head and neck cancers. As part of its global commercialization strategy to enter into regional licensing deals with other market dominant biopharmaceutical companies in territories where there is a high prevalence of HPV-associated cancers, Advaxis has granted exclusive licenses for the development and commercialization of ADXS-HPV in Asia and India.

ADXS-cHER2 is an immunotherapy for the treatment of HER2-overexpressing cancers (such as breast, gastric, esophageal, and other cancers in humans and for osteosarcoma in canines). Advaxis' lead animal-health immunotherapy, ADXS-cHER2, has demonstrated encouraging survival data in a Phase 1 trial in canine osteosarcoma. These data provide the rationale to advance this same immunotherapy into a Phase 1 clinical trial in patients with HER2-overexpressing cancers such as breast, gastric, esophageal, and others. The Company is preparing an IND submission for ADXS-cHER2 in the treatment of HER2 overexpressing cancers in 2014.

Advaxis has created more than 20 distinct immunotherapies based on its platform, either directly or through strategic collaborations with recognized cancer centers of excellence. We have clinical research collaborations with the University of Pennsylvania, Brown University, the Georgia Regents University Cancer Center, the Icahn School of Medicine at Mount Sinai, and others.

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Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis' ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis' proprietary immunotherapy, ADXS-HPV; whether Advaxis immunotherapies can redirect the powerful immune response all human beings have to the bacterium to cancers. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis' SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2013, which is available at Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

UC Disclaimer

The information stated above was prepared by Advaxis, Inc. and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of Advaxis, or any of its products, by The Regents of the University of California, its officers, agents and employees.

CONTACT: Advaxis Contact: Lisa Caperelli Senior Director of Investor Relations and Corporate Communications Advaxis, Inc. 215.206.1822 Media Contact: Tiberend Strategic Advisors, Inc. Andrew Mielach 212.375.2694