Advaxis, Inc., a leader in developing the next generation of cancer immunotherapies, has dosed its first patient in a phase I/II “window of opportunity” study being conducted by the Icahn School of Medicine at Mount Sinai. Patients diagnosed with HPV-associated head and neck cancer will receive ADXS-HPV immunotherapy during the “window” of time between initial diagnosis and minimally invasive transoral robotic surgery (TORS) to remove their tumours.

HPV-associated head and neck cancer is the most rapidly growing form of head and neck cancer, and is caused by the same virus that causes cervical cancer.

“This study will characterize the potential of ADXS-HPV to stimulate the patient’s own immune system to fight cancer prior to receiving TORS,” commented Dr Robert Petit, chief scientific officer of Advaxis. “The short and long-term side effects of surgery followed by chemotherapy and radiation can be disfiguring and interfere with the patient’s ability to swallow and eat. We have partnered with experts at one of the top head and neck cancer treatment centers in the world who share our goal of making more effective and less toxic treatments available for patients with this terrible disease. It is our shared hope that adding the power of our newly emerging immunotherapy to technological advances like TORS may significantly improve the treatment options and long-term outcomes for head and neck cancer patients and survivors.”

This investigator-initiated clinical study is designed to enroll 25 patients with human papillomavirus (HPV)-positive stage II-IV squamous cell carcinoma of the oropharynx who are scheduled to undergo TORS. TORS is an FDA-approved technology developed at Mount Sinai for patients with head and neck cancer and is considered to be the standard of care therapy in appropriate patients. Fifteen patients will receive ADXS-HPV treatment followed by TORS and ten patients will serve as the control group and receive only TORS. The primary objective of this study is to assess the safety, efficacy, and immunogenicity of ADXS-HPV in this patient population prior to undergoing surgery. The Mount Sinai immunology core lab will fully characterize the immunologic effects of ADXS-HPV treatment on both the patient and his or her tumors. If successful, ADXS-HPV could potentially be used before surgery or other cytotoxic treatments to reduce the dose of cytotoxic therapies, decrease toxicities, and enhance long-term disease control.

ADXS-HPV is Advaxis’ lead immunotherapy product candidate for the treatment of HPV-associated cancers. It is currently under investigation in three HPV-associated cancers: cervical cancer, head and neck cancer, and anal cancer. In cervical cancer, a recently completed phase II study of ADXS-HPV demonstrated improved survival and a manageable safety profile alone or in combination with chemotherapy. Clinical trials in head and neck cancer and in anal cancer are ongoing. Advaxis has received Orphan Drug Designation from the US Food and Drug Administration for ADXS-HPV for HPV-associated head and neck cancer and for anal cancer.

Advaxis is a clinical-stage biotechnology company developing the next generation of cancer immunotherapies.