Patients with high risk squamous cell cancer of the oral cavity (SCCOC) have a nearly 70% recurrence rate within 3 years despite surgery, chemoradiotherapy, followed by a clean CT scan. Treatment options at that point are quite limited. Biropepimut-S (GL-0817) is currently in a double-blind, placebo-controlled clinical trial in seven countries to prevent recurrence of high risk SCCOC. Biropepimut-S is a highly engineered peptide immunomodulator.

Gliknik expects to complete enrollment of this trial in April 2019. Patients will then be followed for 2 years to determine whether biropepimut-S with adjuvants GM-CSF and Poly ICLC can reduce the tumor recurrence rate in these patients. More information on this trial is available at clinicaltrials.gov.

Biropepimut-S is a highly engineered peptide immunomodulator targeted against important epitopes within the cancer protein MAGE-A3.

Designed in response to previous challenges with clinical immunomodulator studies, biropepimut-S has a number of advanced features that are not available in any competitive product and that enhance antigen presentation. These features and a carefully designed trial for a population with low initial tumor burden make this an important clinical trial for these patients.

Biropepimut-S was invented after scientific founder Scott Strome, MD and his research partner at the Mayo Clinic, Lieping Chen MD, PhD, discovered the utility of antibodies against checkpoint inhibitor PD-L1 in preventing tumor-induced suppression of the normal immune system. Dr. Strome worked with Esteban Celis, MD, PhD to create immunomodulatory cancer therapeutic vaccines with novel properties based on lessons learned from cancer vaccines that had been clinically tested. The thinking was that checkpoint inhibitors would be more effective when paired with effective antigen presentation.

Biropepimut-S is directed against well characterized MAGE-A3 antigen epitopes that are expressed in many cases of head and neck cancer, multiple myeloma, lung cancer and other tumor types. It was designed to enter the cell more effectively than predecessor compounds, travel intact through the cell without being degraded, be cleaved to intact antigen epitopes better than predecessor compounds, and generate responses in cytotoxic (or “killer”) T cells, T-helper cells, and in B-cells producing antibody responses. These peptide-specific immune responses were indeed observed when GL-0817 was assessed in two phase 1 clinical trials in patients with advanced head and neck cancer and in a phase 2 combination trial with multiple therapies in multiple myeloma.