Biopharmaceutical company Peregrine Pharmaceuticals, Inc., dedicated to the development of immuno-oncology therapeutics, recently announced its decision to expand its current partnership with AstraZeneca to cover a second clinical trial designed to study the benefits of combining Peregrine’s bavituximab, a phosphatidylserine (PS)-targeted immune-activator, and AstraZeneca’s durvalumab (MEDI4736), an anti-PD-L1 immune checkpoint inhibitor. The international, randomized Phase II trial will involve patients with non-squamous non-small cell lung cancer (NSCLC) who had previously undergone other treatments. Peregrine will be conducting the new study.
Bavituximab works by targeting and modulating phosphatidylserine, a potent immunosuppressive molecule found in large amounts on the surface of cancer cells. Previously completed studies with bavituximab demonstrated its ability to increase activated T-cell activity on tumors, effectively disabling these cells’ immunosuppressive microenvironment. In preclinical studies, this mode of action proved highly beneficial when combined with a checkpoint inhibitor and monoclonal antibody such as durvalumab, which helps boost T-cell activity on the tumor.
The trial will evaluate NSCLC patients retrospectively for the relationship between their PD-L1 levels and clinical outcomes, effectively building on the two parties’ non-exclusive partnership, which was signed in August 2015 for a Phase I/Ib basket trial that studied the effects of a combined treatment of bavituximab and durvalumab together with chemotherapy.
“In the short period of time that we have been working with AstraZeneca, we have been very impressed with the company’s commitment to innovative translational efforts that will help us better understand the dynamics of tumor immunity and clinical response to durvalumab and bavituximab combination in a range of cancers,” said Joseph Shan, MPH, vice president, clinical and regulatory affairs of Peregrine. “We expect this extension of our collaboration with AstraZeneca will allow us to run a much more cost-effective and time-efficient trial than would have been possible under our previously planned study using Opdivo as the combination drug in the same lung cancer population. This Phase II study offers several key advantages including a supply of durvalumab that will enable us to conduct a global trial that can enroll patients more rapidly. In addition, the expanded collaboration provides for a more cohesive clinical program utilizing the same PD-L1 and other biomarker analysis across both the new Phase II trial and the already planned Phase I/Ib study combining durvalumab and bavituximab in multiple indications.”