PRINCETON, N.J., July 28, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc.(Nasdaq:ADXS), a biotechnology company developing the next generation of cancer immunotherapies, announced that it has received a notice of allowance from the Japan Patent Office for a patent application related to the Advaxis proprietary Lm-LLO cancer immunotherapy platform technology. Once issued, this patent will provide protection in Japan until 2029.
The claims under the patent cover composition of matter and methods of use for combining Advaxis's proprietary immunogenic, recombinant tLLO fused to full and partial antigens of particular interest to target cancers such as cervical, ovarian, melanoma, lung, and head and neck. The antigens covered under the claims include HPV-related and prostate cancer antigens, which are expressed in cervical and prostate cancer. Several of these claims are already patented in the United States. This patent along with the other issued patents in Japan, provides stronger protection for current and future uses of Advaxis immunotherapies.
"The extension of our patent protection to cover composition of matter and methods for our cancer immunotherapies in Japan, demonstrates our commitment to broadly protect our proprietary Lm-LLO technology," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "This additional patent is important to the future development of our technology as we look to expand our assets into other geographic areas and demonstrates our strong momentum in developing our Lm-LLO platform for multiple cancer indications. Once issued, we will have six patents in Japan."
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 Lm-LLO technology, using bioengineered live attenuated Listeria monocytogenes 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 designation 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 is planning to evaluate the combination of ADXS-HPV with an anti-PD-L1 immune checkpoint inhibitor in HPV-associated cancers.
Advaxis's second immunotherapy candidate in clinical testing will be 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 overexpressing cancers. Her2 is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. 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 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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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' 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. firstname.lastname@example.org 215.206.1822 Media Contact: Tiberend Strategic Advisors, Inc. Amy S. Wheeler email@example.com 646.362.5750
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