Advaxis Begins HPV-Cancer Trial

Advaxis and the Icahn School of Medicine at Mount Sinai (ISMMS) will begin a Phase I/II study of ADXS-HPV in 25 patients with Human Papilloma Virus (HPV)-positive head and neck cancer. This trial will be the first study to evaluate the effects of ADXS-HPV in patients when they are initially diagnosed with HPV-associated head and neck cancer, prior to receiving any chemotherapy or radiation. This study will be an important first step toward understanding ADXS-HPV’s potential to treat this type of cancer before chemotherapy and/or radiation and its potential to reduce the need for these treatments.

ADXS-HPV is Advaxis’ lead immunotherapy product candidate for the treatment of HPV-associated cancers and has achieved proof-of-concept, demonstrating clinical activity and a manageable safety profile in patients with recurrent cervical cancer in a recently completed Phase II study. Advaxis received Orphan Drug Designation from the FDA for ADXS-HPV for HPV-associated head and neck cancer in early November.

This non-randomized investigator-initiated study has been designed to evaluate the safety and immunogenicity of ADXS-HPV in patients with HPV-positive stage II-IV squamous cell carcinoma of the oropharynx (OPCSC). In this study, 15 patients will receive ADXS-HPV treatment followed by ablative transoral robotic surgery (TORS), and 10 patients will serve as the control group and receive only TORS. TORS is FDA-approved for head and neck cancer and is considered to be the standard of care therapy for OPCSC in appropriate patients.