PRINCETON, N.J., June 23, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, has received notice of allowance from the United States Patent and Trademark Office (USPTO) on two patents covering the composition and methods of use for ADXS-cHER2 (Patent Numbers 12/945,386 and 13/210,696). Advaxis is developing ADXS-cHER2 to target the Her2 receptor, which is overexpressed in certain solid-tumor cancers, including bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. Advaxis plans to initiate a Phase 1 trial with ADXS-cHER2 in pediatric osteosarcoma, for which it received Orphan Drug Designation, and is pursuing early development clinical collaborations for breast, esophageal and gastric cancers.
The first patent covers composition for ADXS-cHER2, as well as methods of composition use for preventing or eliciting an immune response against, or treating, tumors that express Her2/neu in humans. This patent also covers ADXS-cHER2 use within the tumor, specifically: increasing the ratio of CD8 T cells to regulatory T cells (Tregs) and decreasing the frequency of Tregs and myeloid-derived suppressor cells (MDSCs). Additionally, the patent covers ADXS-cHER2 use for preventing an escape mutation in the treatment of Her2/neu over-expressing tumors in a subject.
The second patent covers methods of ADXS-cHER2 use for preventing, eliciting an immune response against, or treating Her-2/neu-expressing tumors, such as osteosarcoma, in non-human animals, particularly pet dogs. The allowed method claims also cover ADXS-cHER2 use for preventing an escape mutation in the treatment of Her2/neu over-expressing tumors in non-human animals, particularly dogs.
"These two patents cover the ways in which our ADXS-cHER2 immunotherapy product candidate increases anti-cancer immune response in the tumor microenvironment in both humans and animals," said Daniel J. O'Connor, President and CEO of Advaxis. "Allowance of these patents further expands an already robust IP portfolio for our ADXS-cHER2 asset as we move forward with the clinical trial program."
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 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, 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, 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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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 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's licensing partners; the initiation or a registration clinical trial program for cervical cancer in 2014; Advaxis's 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'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 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.