ADXS-PSA Patent Covers a Recombinant Listeria Strain Encoded with Recombinant Fusion Peptide of KLK3 Peptide Linked to Non-KLK3 Peptide
ADXS-HER2 Patent Covers Method of Use in Treating HER2/Neu Expressing Tumors, Particularly Osteosarcoma, in Non-Human Animals and Companion Dogs
PRINCETON, N.J., April 28, 2015 (GLOBE NEWSWIRE) — Advaxis, Inc. (ADXS), a cancer immunotherapy company, today announced that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 9,012,141 with composition of matter claims covering the Advaxis product candidate, ADXS-PSA, and U.S. Patent No. 9,017,660 with methods of use claims covering the Advaxis product candidate, ADXS-HER2.
The first patent, which will expire on November 26, 2028, covers constructs related to ADXS-PSA, Advaxis’s Lm-LLO immunotherapy candidate being developed to address prostate cancer. Specifically, the patent provides composition of matter protection for a recombinant Listeriastrain encoded with recombinant fusion peptide of KLK3 peptide linked to non-KLK3 peptide.
The second patent, which will expire on January 14, 2031, covers methods of use for ADXS-HER2, Advaxis’s Lm-LLO immunotherapy candidate designed to target HER2 receptor expressing cancers. The patent provides method of use protection in treating HER2/Neu expressing tumors, particularly osteosarcoma, in non-human animals and companion dogs.
Daniel J. O’Connor, President and Chief Executive Officer of Advaxis, stated, “We are very pleased to have been granted these patents by the USPTO as it affirms the novelty of ADXS-PSA and ADXS-HER2. Additionally, these patents further strengthen our intellectual property estate governing our proprietary Lm cancer immunotherapies, a technology which the scientific founder of our company pioneered and around which Advaxis holds broad patent protection.”
Currently Advaxis has 29 granted patents and 35 pending applications in the United States, in addition to having 54 granted foreign patents and 55 pending foreign applications.
Advaxis’s owned or exclusively licensed patent applications and patents provide broad and specific coverage of Advaxis’s products ADXS-HPV, ADXS-PSA, and ADXS-HER2 and methods of use governing multiple treatment indications where Advaxis has active development programs. Additionally, the patent protection extends to combination therapies involving Advaxis’s technologies and those technologies under which Advaxis had entered collaboration agreements (MedImmune and Merck) and where Advaxis has advanced research (ADXS-HER2 + radiation therapy).
Moreover, Advaxis’s owned or exclusively licensed patent applications and patents extend coverage for additional Lm immunotherapies, including recombinant attenuated Listeria monocytogenes expressing fusion proteins, stand-alone fusion proteins, nucleic acid vectors encoding fusion proteins, as well as multivalent, bivalent and dual delivery (of antigens) Listeria. These patents cover the modulation of tumor microenvironment cells, the treatment of diseases including cancer and infectious and parasitic diseases, and the modulation and reconstitution of immune responses. The patents and applications cover Listeria-based immunotherapies alone or as part of a combination therapy.
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(R) (pembrolizumab). The ongoing clinical trial is designed to 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-HER2 to target the HER2 receptor expressing cancers. HER2 is expressed in certain solid-tumor cancers, including osteosarcoma, breast cancer, esophageal, and gastric cancer. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. 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.
For more information about our cancer immunotherapies please visit www.advaxis.com.
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.
KEYTRUDA is a registered trademark of Merck & Co., Inc.