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Data Published by Researchers at the National Cancer Institute Further Identifies How Advaxis's Lm-LLO Immunotherapy Eradicates Tumors

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PRINCETON, N.J., June 4, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing cancer immunotherapies, announced the publication of preclinical research with its lead candidate, ADXS-HPV for the treatment of HPV-associated cancers in the journal, Cancer Immunology Research. In this publication, researchers at the National Cancer Institute (NCI) reported on the biologic mechanisms behind the unique ability of ADXS-HPV to decrease the immunosuppressive activity of Tregs in the tumor microenvironment that result in increased anti-tumor activity. This research demonstrates the critical role of the tLLO peptide fusion and the strong adjuvant effect of tLLO as contributing to the increase in activated T-cells and the relative decrease in the number of Tregs in tumors, thereby increasing anti-tumor activity.

The research was conducted by Dr. Zhisong Chen, Dr. Samir Khleif and their research team at the Vaccine Branch, center for Cancer Research, NCI, NIH. The research was supported by the Intramural Research Program of the Center for Cancer Research, NCI, NIH and funded in part by Advaxis through a collaborative research and development agreement. The publication, entitled, "Episomal expression of a truncated listeriolysin O (LLO) in LmddA-LLO-E7 vaccine enhances anti-tumor efficacy by preferentially inducing CD4+FoxP3- T cell and CD8+ T cell expansion," by Drs. Chen, Ozbun, Chong, Wallecha, Berzofsky, and Khleif, reported the complete regression of tumors in about 40% of mice after two vaccinations with ADXS-HPV. Furthermore, with the exception of one, these mice survived at least six months without relapse.

"This preclinical study conducted by researchers at the NCI further demonstrates how our proprietary Listeria-based cancer immunotherapy platform works, altering the microenvironment within the tumor to shrink, and in some cases, completely eliminating the tumor," said Daniel J. O'Connor, Advaxis Chief Executive Officer. "Advaxis's proprietary fusion with tLLO and the adjuvant effect of LLO in ADXS-HPV induced the strongest tumor regression."

In this preclinical study, Advaxis's Lm-based immunotherapies decreased the proportion of Tregs cells in tumors by causing preferential expansion of CD4+FoxP3- (activated) T cells and CD8+ Foxp3- (activated) T cells first in the blood and lymphoid tissue of the mice, and subsequently infiltrating the tumors and improving the ratio of activated T cells to Tregs inside the tumor microenvironment hereby enabling HPV targeted killer Tcells to eliminate the tumor. This activity was reported to be due to a mechanism dependent on and directly mediated by LLO, which was confirmed using a recombinant Lm where LLO was replaced with cytolysin Perfringolysin O (PFO) allowing exit of this strain from the phagolysosome.

"These results mark progress in our understanding of the potential mechanism behind the unique clinical activity of ADXS-HPV that has been associated with CRs, PRs and apparent prolonged survival as a single agent in recurrent cervical cancer in clinical trials," commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. "The results are better than those achieved in earlier studies with different (non-Advaxis) Lm-based immunotherapies. They suggest that tLLO serves as a promising adjuvant and that its incorporation into ADXS-HPV is a critical contributor to the changes in the tumor microenvironment that favor immune killing of the tumor cells."

ADXS-HPV is in clinical trials for three HPV-associated cancers: cervical cancer, head and neck cancer and anal cancer. Advaxis reported final Phase 2 data in recurrent cervical cancer at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting and plans to move forward with a registration program in recurrent cervical cancer.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary platform intended to redirect the immune system to kill cancer. The Advaxis technology, using bioengineered live attenuated bacteria, is the only known cancer immunotherapy shown in preclinical studies to neutralize Tregs and MSDCs, that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan drug status for each of these three indications. The Company plans to initiate a registrational clinical program for cervical cancer in 2014 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis's second immunotherapy candidate is ADXS-PSA which is being developed to address prostate cancer. Advaxis is planning to file an IND with the FDA and initiate a Phase 1 clinical study with ADXS-PSA in 2014. Advaxis is also developing ADXS-cHER2, to target the HER2 receptor, which is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, and gastric cancer. Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, a model for human bone cancer. Advaxis is pursuing a clinical program in pediatric osteosarcoma and has licensed ADXS-cHER2 and three other immunotherapy constructs to a major animal-health company. Advaxis is planning to file an IND for ADXS-cHER2 in HER2 overexpressing cancers.

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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 higher doses and multiple treatment cycles of ADXS-HPV can further improve clinical outcomes and quality of life; Advaxis moving forward with a registration program in recurrent cervical cancer; the collaborative efforts of Advaxis' licensing partners; the initiation or a registration clinical trial program for cervical cancer in 2014; Advaxis' development of ADXS-cHER2 for both human and animal health and its pursuit of a clinical program in pediatric osteosarcoma. 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 http://www.sec.gov. 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.

CONTACT: Advaxis Contact: Lisa Caperelli Senior Director of Investor Relations and Corporate Communications Advaxis, Inc. caperelli@advaxis.com 215.206.1822 Media Contact: Tiberend Strategic Advisors, Inc. Amy S. Wheeler awheeler@tiberend.com 646.362.5750

Source:Advaxis