Researchers at Baylor College of Medicine have received at $1.1 million grant from the U.S. Food and Drug Administration to advance clinical studies of an experimental immunotherapy for human papillomavirus, or HPV, related throat cancer.

“HPV is a significant cause of cancers worldwide, including cancers of the throat, cervix and other types,” said Dr. Andrew Sikora, leader of the head and neck cancer program in the NCI-Comprehensive Designated Dan L Duncan Cancer Center and an associate professor of otolaryngology at Baylor, who will serve as the principal investigator on the grant. “HPV-related throat cancer is currently the fastest-growing type of head and neck cancer.”

Vaccines and other immunotherapies targeting HPV are designed to direct the patient’s immune response against HPV proteins, thus killing the HPV-infected cancer cells, he said.

“One innovative approach to immunotherapy is engineering a bacteria called Listeria monocytogenes – which naturally induces a potent immune response – to deliver tumor antigens directly to the patient’s immune cells,” said Sikora, also a Carolyn Weiss Law Translational Research Scholar at Baylor.

The treatment, called axalimogene filolisbac (ADXS11-001) and developed by Advaxis, is a Listeria-based HPV vaccine that works by stimulating an immune response to HPV in patients with HPV-associated throat cancers.

Sikora will collaborate with Advaxis and the Icahn School of Medicine at Mount Sinai in New York City.

The grant was given by the FDA’s Orphan Products Grants Program, which supports clinical development of new treatments for rare diseases or conditions where no current treatment exists or superior treatments are needed.

Currently, HPV-related throat cancer is treated with surgery, radiotherapy and/or chemotherapy. Immunotherapy is a new and promising approach to HPV-related cancers.

Other collaborators on the grant include Drs. Brett Miles, Eric Genden and Marshall Posner from Mount Sinai.