Advaxis, a biotechnology company that develops cancer immunotherapies, has entered a clinical trial collaboration with MedImmune, the biologics research and development arm of AstraZeneca.
The phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis' cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and head and neck cancer, according to the companies.
Both MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body's immune system to fight cancer. MEDI4736 is designed to counter the tumor's immune-evading tactics by blocking a signal that helps tumors avoid detection, while ADXS-HPV enhances the ability of immune cells to combat the tumor. Preclinical evidence suggests that the combination of ADXS-HPV with a checkpoint inhibitor, such as MEDI4736, can enhance overall antitumor response.
Under the terms of the agreement, MedImmune and Advaxis will 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, and the phase II portion will assess the safety and efficacy of the combination. The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted.
Also under the terms of the deal, MedImmune has a nonexclusive relationship with respect to HPV-driven tumor types. MedImmune has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.
