AstraZeneca and Peregrine Pharmaceuticals said today they will collaborate on a cancer immunotherapy clinical trial designed to assess Peregrine’s bavituximab in combination with AstraZeneca's durvalumab (formerly MEDI4736). The value of the nonexclusive collaboration was not disclosed.
The planned Phase I/Ib trial will evaluate the safety and efficacy of bavituximab and durvalumab with chemotherapy in multiple solid tumors, AstraZeneca and Peregrine said.
The Phase I portion of the trial is expected to establish a recommended dose regimen for the combination. The Phase Ib portion of the trial is intended to assess the safety and efficacy of the investigational combination. Peregrine will conduct the initial trial.
Bavituximab—the lead compound in Peregrine's immuno-oncology development program—is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody. Bavituximab is designed to block phosphatidylserine (PS) signals that inhibit the ability of immune cells to recognize and fight tumors, and send an alternate immune activating signal that increases activated T cells in those tumors.
Bavituximab is under study in the Phase III SUNRISE trial as a treatment of second-line non-small lung cancer, which compares the compound plus chemotherapy docetaxel against placebo plus docetaxel in patients with second-line non-small cell lung cancer (NSCLC), as well as in several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The compound has been granted Fast Track designation by the FDA for the potential treatment of second-line NSCLC.
Durvalumab, a Phase III human monoclonal antibody, is an immune checkpoint inhibitor against programmed cell death ligand 1 (PD-L1). The compound is designed to fight cancer by blocking signals from PD-L1 that help tumors avoid detection by the immune system.
According to Peregrine, preclinical data has shown that combining bavituximab with PD-L1 antibodies and other checkpoint inhibitors prolong the ability of tumor-specific T-cells to continue attacking the tumor.
“Data generated to date have shown significant potential for combining bavituximab with agents targeting the PD-1/PDL-1 pathway and we're excited to further explore this approach in studies with AstraZeneca's durvalumab,” Peregrine president and CEO Steven W. King said in a statement.
Added Robert Iannone, AstraZeneca’s head of immuno-oncology, global medicines development: “Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers.”