US-based clinical-stage biotechnology firm Advaxis has dosed the first patient with ADXS-HPV immunotherapy in a Phase I/II ‘window of opportunity’ trial for the treatment of patients diagnosed with HPV-associated head and neck cancer.

Icahn School of Medicine at Mount Sinai is carrying out the trial, under which patients will be given ADXS-HPV immunotherapy during the ‘window’ of time between initial diagnosis and minimally invasive transoral robotic surgery (TORS) to remove their tumours.

ADXS-HPV is the company’s lead immunotherapy product candidate for the treatment of HPV-associated cancers and is currently under investigation in three HPV-associated cancers: cervical cancer, head and neck cancer, and anal cancer.

Advaxis chief scientific officer Robert Petit said the trial will characterise the potential of ADXS-HPV to stimulate the patient’s own immune system to fight cancer prior to receiving TORS.

"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," Petit said.

"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.

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"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."

A total of 25 patients with human papillomavirus (HPV) positive stage II-IV squamous cell carcinoma of the oropharynx who will undergo TORS will be enrolled in the investigator-initiated clinical trial.

"The primary objective of the trial is to evaluate the safety, efficacy, and immunogenicity of ADXS-HPV in this patient population before undergoing surgery."

The company said that TORS is an FDA-approved technology developed at Mount Sinai for patients with head and neck cancer and is also considered to be the standard of care therapy in suitable patients.

In the trial 15 patients will receive ADXS-HPV treatment followed by TORS, while the remaining ten patients will serve as the control group and receive only TORS.

The primary objective of the trial is to evaluate the safety, efficacy, and immunogenicity of ADXS-HPV in this patient population before undergoing surgery.

During the trial, the Mount Sinai immunology core lab will fully characterise the immunologic effects of ADXS-HPV treatment on both the patient and his or her tumours and 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.

Image: Human papillomavirus (HPV) is a DNA virus from the papillomavirus family that is capable of infecting humans. Photo: courtesy of