The grant was administered through the FDA’s Orphan Products Grants Program, created more than 30 years ago by the Orphan Drug Act to promote the development of products for rare diseases. It is a competitive program that receives approximately 100 applications per year, from which typically 10 to 15 applications are selected for funding each fiscal year.
“Applications to the Orphan Products Grants Program undergo rigorous review for scientific and technical merit by a panel of experts to compete for funding,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “We are encouraged to see axalimogene filolisbac recognized as viable by being awarded a grant for its clinical research that could ultimately contribute to market approval.”
The Phase 2 study will be led by Andrew G. Sikora, M.D., Associate Professor of Otolaryngology at BCM and co-director of the Head and Neck Cancer Program in the NCI Comprehensive-Designated Dan L. Duncan Cancer Center at Baylor, and is supported by key investigators Brett Miles, M.D. and Marshall Posner, M.D. at the Icahn School of Medicine at Mount Sinai. The study is designed to evaluate the efficacy of axalimogene filolisbac as neoadjuvant treatment prior to robot-assisted surgery in patients with HPV-associated oropharyngeal cancer.
“We hope to improve outcomes in HPV-associated head and neck cancer by exploring axalimogene filolisbac in this indication, where existing treatment options are associated with risk of long-term morbidity,” said Dr. Sikora. “If successful, this trial could pave the way for immunotherapy to become a standard treatment for HPV-associated cancers.”
HPV-Associated Oropharynx (Throat) Cancer
Human papillomavirus (HPV) is an important cause of cancers worldwide, including cancers of the oropharynx (throat), cervical cancer, and other cancers. HPV-related throat cancer is currently the fastest-growing type of head and neck cancer, with an incidence of approximately 15,500 new cases of HPV-associated oropharynx cancer in the U.S. per year.
About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology(TM) immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s LmTechnology(TM).
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 LmTechnology(TM), using bioengineered live attenuated Listeria monocytogenes (Lm) 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 Technology(TM) immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential 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 axalimogene filolisbac orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn,Facebook, YouTube and Google+.
This media statement 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, axalimogene filolisbac. 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.