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US FDA's OOPD awards grant for phase 2 study of axalimogene filolisbac in HPV-associated head & neck cancer

Princeton, New Jersey
Wednesday, September 16, 2015, 16:30 Hrs  [IST]

Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, announced that the US Food and Drug Administration's (FDA) Office of Orphan Products Development (OOPD) awarded a grant totaling $1.1 million over three years to Baylor College of Medicine in support of an ongoing phase 2 trial of Advaxis's lead Lm Technology immunotherapy, axalimogene filolisbac (ADXS-HPV), in HPV-associated oropharynx (throat) cancer, a type of head and neck cancer.

The grant was administered through the FDA's Orphan Products Grants Programme, created more than 30 years ago by the Orphan Drug Act to promote the development of products for rare diseases. It is a competitive programme 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 Programme 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 recognised 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 Programme 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."

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 US per year.

Axalimogene filolisbac is Advaxis's lead Lm Technology 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 tumour responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company's Lm Technology.


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