Biropepimut-S (GL-0817) 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.

Gliknik is currently enrolling 80 patients in a 45-site, phase 2, double-blind, placebo-controlled clinical trial in the U.S. and six other countries (Hungary, Spain, Serbia, Poland, Germany and Ukraine), 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.

 

MAGE-A3 is expressed in many cases of head and neck cancer, multiple myeloma, lung cancer and other tumor types. Designed in response to previous challenges with clinical immunomodulator studies, GL-0817 has a number of advanced features that are not available in any competitive product. 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.

Patients with high risk oral cavity cancer have a high rate of recurrence despite attempted curative surgery and post-operative chemotherapy and radiotherapy, with risk based on certain pathology results at the time of resection. In fact, even after receiving these state-of-the-art therapies and having no detectable tumor, about 70% of high risk oral cavity cancer patients recur within three years. Unfortunately, treatment options at that point are quite limited.