AstraZeneca’s biologics research and development arm MedImmune has entered into a clinical trial collaboration with Advaxis, a US-based biotechnology firm that develops cancer immunotherapies.
As part of the collaboration, the Phase I/II immunotherapy trial will assess the safety and efficacy of MedImmune’s MEDI4736 in combination with Advaxis’ ADXS-HPV to treat patients with advanced, recurrent or refractory human papillomavirus (HPV) associated cervical cancer and HPV-associated head and neck cancer.
MEDI4736 is an investigational anti-PD-L1 immune checkpoint inhibitor designed to counter the tumour’s immune-evading tactics by blocking a signal that helps tumours avoid detection. ADXS-HPV is a lead cancer immunotherapy vaccine, which improves the ability of immune cells to fight the tumour.
MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body’s own immune system to help combat cancer.
The preclinical studies have showed that overall anti-tumour response can be improved with the combination of ADXS-HPV with a checkpoint inhibitor, such as MEDI4736.
MedImmune executive vice-president Bahija Jallal said: "Our collaboration with Advaxis is further evidence of MedImmune’s commitment to explore novel combination approaches as we progress our immuno-oncology portfolio.
"We believe there could be an important clinical benefit from the combination of MEDI4736 with Advaxis’s antigen-specific cancer vaccine."
The deal will also see the two firms evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck.
The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, while the Phase II portion will evaluate the safety and efficacy of the combination.
The trial will be funded and carried out by Advaxis, while its results will be used to determine whether further clinical development of the combination is warranted.
MedImmune has a non-exclusive relationship with respect to HPV-driven tumour types and it also has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.
Advaxis chief executive officer Daniel O’Connor said: "This is the first time a PD-L1 checkpoint inhibitor will be used with a new class of immunotherapies. As multiple companies vie for a competitive advantage in the future PD-L1 market, the ability of our immunotherapy platform to attack multiple tumour targets makes it an attractive combination therapy."
The two firms have recently started other immuno-oncology combination trials, including collaboration with biopharmaceutical company Incyte, to evaluate MEDI4736 with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360.