- Advaxis (ADXS -3.8%) and AstraZeneca's (AZN -1.3%) MedImmune announce the initiation of a Phase 1/2 clinical trial evaluating Advaxis' axalimogene filolisbac (ADXS-HPV) in combination with MedImmune's durvalumab (MEDI4736) for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
- The two-part open label study will evaluate the safety and efficacy of axalimogene filolisbac as monotherapy and in combination with durvalumab in ~66 subjects. Phase 1 will establish the maximum tolerated dose while Phase 2 will randomize patients to receive axalimogene filolisbac as monotherapy, durvalumab as monotherapy or the combination. The primary endpoints include objective response rate and progression-free survival. The estimated study completion date is December 2019.
- Axalimogene filolisbac is an immunotherapy based on the Advaxis Lm Technology, which uses live attenuated bioengineered Listeria bacteria to deliver a fusion protein inside cancer cells which then stimulates the immune system to attack the cancer.
- Durvalumab is a monoclonal antibody that binds to PD-L1 (programmed death- ligand 1), a transmembrane protein on cancer cells. PD-L1 suppresses the immune system by binding to the PD-1 receptor found on the surface of activated immune cells. Binding to PD-1 down-regulates the immune system by preventing the activation of T cells.