AstraZeneca announced that its global biologics research and development arm, MedImmune, has entered into clinical trial collaboration with a US-based biotechnology company, Advaxis, Inc., which is developing cancer immunotherapies.

The Phase I and phase II immunotherapy study will assess the efficacy and safety of MEDI4736, MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor in combination with ADXS-HPV, Advaxis’ lead cancer immunotherapy vaccine, as a treatment for patients with refractory, recurrent or advanced human papillomavirus (HPV)-associated cervical cancer and HPV-associated neck and head cancer.

Both ADXS-HPV and MEDI4736 are cancer immunotherapies, which is a new class of treatments that use the body’s own immune system to help fight cancer. ADXS-HPV enhances the ability of immune cells to combat tumour while MEDI4736 is designed to counter the tumour’s immune-dodging tactics by blocking a signal that helps tumours avoid detection. Preclinical evidence suggests that the combination of ADXS-HPV with a checkpoint inhibitor, like MEDI4736, that can enhance overall anti-tumour response.

MedImmune’s Executive Vice President, Dr. Bahija Jalla said that their collaboration with Advaxis is further evidence of MedImmune’s commitment to explore innovative combination approaches as they progress their immuno-oncology portfolio. They believe there could be an important clinical benefit from the combination of MEDI4736 with Advaxis’s antigen-specific cancer vaccine.

Advaxis and MedImmune under the terms of the agreement will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the neck and head. The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase II section will evaluate the safety and efficacy of the combination. The study will both be funded as well as conducted by Advaxis. Results from the study will be used to ascertain whether further clinical development of this combination is warranted.

MedImmune has a non-exclusive relationship with respect to HPV-driven tumour types under the terms of the deal. MedImmune has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.

Advaxis’ Chief Executive Officer, Daniel J. O’Connor said that they are excited to be partnering with MedImmune and evaluating MEDI4736 in combination with their immunotherapy. This is the first time a PD-L1 checkpoint inhibitor will be used with a new class of immunotherapies. As numerous companies contest for a competitive advantage in the future PD-L1 market, the ability of their immunotherapy platform to attack multiple tumour targets makes it an attractive combination therapy.

MedImmune and AstraZeneca have recently initiated other immuno-oncology combination trials, including collaboration with biopharmaceutical company Incyte to study MEDI4736 with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360.