Advaxis gets FDA clearance to begin Phase I/II trial of combination cancer therapy

The trial will be conducted with ADXS11-001 alone or in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736

The combination drug is indicated to treat advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.

MedImmune is the global biologics research and development arm of British drugmaker AstraZeneca.

Advaxis president and chief executive officer Daniel O’Connor said: "We are pleased to have received FDA acceptance for both of our IND applications to evaluate two of our investigational Lm-LLO immunotherapies in combination with two novel checkpoint inhibitors.

"Since entering into the clinical trial collaboration with MedImmune in July, we have progressed rapidly from initial agreement to IND, and we now expect to initiate the ADXS-HPV plus MEDI4736 study by early 2015."

The company is expected to initiate patient enrollment in the trial in early 2015. The Phase I part of the trial will be a dose-confirmation study of ADXS-HPV and MEDI4736 combination therapy.

The trial’s Phase II portion is designed to evaluate the safety and develop an estimate of clinical activity for the combination and monotherapy treatments, including tumor responses and progression-free survival (PFS) by immune-related response evaluation criteria (irRECIST).

During the trial, patients will be randomized into three arms: ADXS11-001 monotherapy, MEDI4736 monotherapy, or ADXS-HPV in combination with MEDI4736.

Both ADXS-HPV and MEDI4736 are members of a new class of cancer treatments called immunotherapies, which are designed to improve the body’s own defenses to combat cancer.