Peregrine Pharmaceuticals, Inc., a biopharmaceutical company, has expanded its ongoing cancer immunotherapy clinical collaboration with AstraZeneca, a global, innovation-driven biopharmaceutical business, to include a second, later-stage trial. The companies will now also evaluate the immunotherapy combination of Peregrine’s phosphatidylserine (PS)-targeted immune-activator, bavituximab, and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in a global phase II study in patients with previously treated squamous or non-squamous non-small cell lung cancer (NSCLC).
The randomized phase II trial will be conducted by Peregrine. As part of the phase II bavituximab and durvalumab combination trial, patients will be evaluated retrospectively for the correlation between their PD-L1 levels and clinical outcomes. This new study builds on the non-exclusive collaboration initiated between the companies in August 2015 to conduct a Phase I/Ib basket clinical trial evaluating the combination of bavituximab and durvalumab with chemotherapy in multiple solid tumours.
Bavituximab and durvalumab are investigational immunotherapies with different mechanisms that assist the body’s immune system in fighting cancer. Bavituximab targets and modulates the activity of phosphatidylserine, a highly immune-suppressive molecule expressed broadly on the surface of cells in the tumor microenvironment. In pre-clinical and translational clinical studies, the treatment increases activated T-cells in tumors and fights cancer by reversing the immunosuppressive environment that many tumors establish in order to proliferate. Durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. Preclinical data have demonstrated that combining the enhanced T-cell mediated anti-tumor activity of bavituximab with checkpoint inhibitors, like PD-L1 antibodies, prolong the ability of tumor-specific T-cells to continue attacking the tumor.
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumours. Bavituximab, the lead compound in Peregrine’s immuno-oncology development program, blocks PS to remove this immunosuppressive signal and sends an alternate immune activating signal. Targeting PS with bavituximab has been shown to shift the functions of immune cells in tumors, resulting in robust anti-tumor immune responses.
Durvalumab is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. Durvalumab blocks these signals, countering the tumor’s immune-evading tactics. Durvalumab is being developed, alongside other immunotherapies, to empower the patient’s immune system and attack the cancer.