Peregrine Pharmaceuticals recently announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a phase III registration trial design of the company’s lead clinical immunotherapeutic candidate bavituximab in second-line non–small cell lung cancer (NSCLC). The trial design was supported by promising data from a phase IIb trial in patients treated with bavituximab plus docetaxel.
The phase III clinical trial will be a randomized, double-blind, placebo-controlled trial evaluating bavituximab plus docetaxel vs docetaxel alone, enrolling approximately 600 patients at sites worldwide. The trial will enroll stage IIIB/IV nonsquamous NSCLC patients who have had disease progression after standard front-line treatment. The primary endpoint of the trial will be overall survival.
This agreement on a phase III trial design with the FDA is a critical milestone for the bavituximab program, said Steven King, President and Chief Executive Officer of Peregrine. “We will now focus on starting the phase III trial while continuing ongoing partnering discussions. With immunotherapies at the forefront of new approaches to treating cancer, we are well positioned with bavituximab’s novel immune activation mechanism to help advance this rapidly evolving field.”
Bavituximab is a first-in-class phosphatidylserine-targeting monoclonal antibody that represents a new approach to treating cancer. Phosphatidylserine is a highly immunosuppressive phospholipid component, usually located inside the membrane of healthy cells. However, when a cell undergoes apoptosis, the phosphatidylserine molecule “flips” and becomes exposed on the outside of cells that line tumor blood vessels, causing the tumor to evade immune detection. Bavituximab targets phosphatidylserine and blocks this immunosuppressive signal, resulting in the maturation of dendritic cells and cancer-fighting (M1) macrophages, leading to the development of cytotoxic T cells that fight solid tumors.
Bavituximab is the lead drug candidate from the company’s phosphatidylserine-targeting technology platform and is currently being evaluated in several solid tumor indications, including non–small cell lung cancer, breast cancer, liver cancer, and rectal cancer. ■