Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 9,084,747 with composition of matter claims covering ADXS-HER2. The patent expands Advaxis’s intellectual property portfolio in claiming numerous compositions for the company’s Lm Technology(TM) immunotherapy candidate designed to target HER2 expressing cancers. The patent also covers methods of using the same compositions for eliciting an immune response against, preventing the onset of, preventing the formation of, impeding a growth of, preventing an escape mutation in the treatment of, or treating a HER2 expressing tumor.
The patent will expire on September 19, 2032, and also covers ADXS-HER2 use for decreasing the frequency of intra-tumoral T regulatory cells, for decreasing the frequency of myeloid derived suppressor cells, or for increasing intratumoral ratio of CD8+/ T regulatory cells.
“We see significant potential for our investigational agents in HER2 expressing cancers,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “This patent rounds out our portfolio, allowing us to maintain the development of ADXS-HER2 and commence enrollment of the first human trial as planned by year end.”
Currently, Advaxis has 29 granted patents and 37 pending applications in the United States, in addition to having 54 granted foreign patents and 60 pending foreign applications.
About HER2 Expressing Cancers
Human epidermal growth factor receptor 2 (HER2) is expressed in a percentage of solid tumors such as breast, gastric, bladder, brain, pancreatic, ovarian and pediatric bone cancer (osteosarcoma). The American Cancer Society estimates that in 2015 in the United States alone there will be 231,840 new cases of invasive breast cancer; 24,590 new cases of gastric cancer; 74,000 new cases of bladder cancer; 22,850 new cases of brain/spinal cancer; 48,960 new cases of pancreatic cancer; 21,290 new cases of ovarian cancer; and 207 new cases of pediatric osteosarcoma. HER2 expression is associated with more aggressive disease, increased risk of relapse and decreased overall survival, and is an important target for immunotherapy.
ADXS-HER2 is an Lm Technology(TM) immunotherapy product candidate being developed by Advaxis for the targeted treatment of HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma in May 2014. Advaxis is developing ADXS-HER2 for both human and animal-health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology(TM). The Lm 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 LmTechnology 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 U.S. Food and Drug Administration (FDA) has granted Advaxis orphan drug designation for each of these three indications. For additional information on Advaxis, visit www.advaxis.com and connect onTwitter, LinkedIn, Facebook, YouTube and Google+.
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; and the safety and efficacy of Advaxis’s proprietary immunotherapy, ADXS-HPV. 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, 2014, 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.
Greg Mayes, Executive Vice President and COO
609.452.9813 ext. 102
JPA Health Communications