Advaxis's Listeria-based Lm-LLO Immunotherapy Featured in Nature Biotechnology

PRINCETON, N.J., Dec. 11, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that its Lm-LLO immunotherapy technology is featured in an article in the December 2014 issue of Nature Biotechnology. Entitled "Listeria vaccines join the checkpoint frenzy," the article explores the potential of the Listeria bacterium as a vector to enhance an anti-tumor response given its ability to induce powerful innate and adaptive immune responses.

Nature Biotechnology is the leading peer-reviewed scientific journal in the field of biotechnology. The monthly journal publishes peer-reviewed research results, as well as expository articles on the commercial business sector of the biotechnology field.

Advaxis is featured in the article as one of the leading companies pursuing Listeria-based cancer immunotherapies. Advaxis's Lm-LLO immunotherapy technology is recognized as being unique in the field of immunotherapy drug development in that it uses a live, attenuated bacterial platform genetically engineered to attack cancer tumors and minimize toxicity.

In the article, Laurence Wood, Ph.D., assistant professor in the Department of Immunotherapeutics and Biotechnology at the Texas Tech University Health Sciences Center in Abilene, stated that, "Interest from big pharma is a huge deal. Down the road, there will likely be even greater interest in getting bacterial-based cancer vaccines through clinical trials, alone or in combination with other drugs."

"One major advantage of Listeria is that it readily gets into and thrives in the cytosol of antigen-presenting cells," adds Dr. Wood in the article. "It is early days, but the revived interest could be warranted. That Listeria based vaccines have shown improved or similar efficacy to standard of care with far fewer adverse events is incredibly promising."

Further, the article highlights the observation that Advaxis's Lm-LLO platform is designed in a manner that potentially produces an immune response at a lower dose and makes it easier to combine with other immunotherapy technologies, such as checkpoint inhibitors.

David J. Mauro, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Advaxis, commented, "The potential of Listeria-based cancer immunotherapies is gaining increasing interest within the oncology field as a promising route to developing a host therapies, and, as evidenced by this article in Nature Biotechnology, Advaxis's Lm-LLO platform and rapidly advancing pipeline of compounds are viewed as clear leaders within the industry. Additionally, as the article notes, the advantages that our Lm-LLO technology offers as a combination therapy makes it attractive to potential development partners with checkpoint inhibitor technologies. This attribute was key to the two development agreements that we initiated with MedImmune and Merck, both of which we look forward to advancing to the clinic in early 2015."

The Nature Biotechnology article can be accessed via the following URL: A subscription to the magazine or one-time purchase fee is required.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm-LLO platform technology. The Lm-LLO technology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm-LLO 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 designation for each of these three indications. The Company plans to initiate a registrational clinical program for cervical cancer in 2015 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for a Phase 1/2 immunotherapy study to evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis's ADXS-HPV as a treatment for patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.

Advaxis's second Lm-LLO immunotherapy candidate in clinical testing will be ADXS-PSA, which is being developed to address prostate cancer. Advaxis entered into a clinical trial collaboration agreement with Merck & Co., Inc. ("Merck"), known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab). The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.

Advaxis is also developing Lm-LLO immunotherapy ADXS-cHER2, to target the Her2 receptor overexpressing cancers. Her2 is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. ADXS-cHER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis is planning to file an IND for ADXS-cHER2 in Her2 overexpressing cancers and to conduct a clinical program in pediatric osteosarcoma. Advaxis has licensed ADXS-cHER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.

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Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis's 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's 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.

KEYTRUDA is a registered trademark of Merck & Co., Inc.

Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
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Amy S. Wheeler