The study of AST-008 in combination with pembrolizumab, in Phase 1b/2, initiated its first dose to patient on February 25, 2019, by Exicure, Inc., a pioneer in gene regulatory and immunotherapeutic drugs.
The drug AST-008 is being analyzed for curing patients with superficial injectable tumors in advanced or metastatic solid tumor conditions including Merkel cell carcinoma, head and neck squamous cell carcinoma, cutaneous squamous cell carcinoma and melanoma. Exicure has opened the enrollment for the trial for patients with the disease listed above on the website clinicaltrials.gov NCT03684785.
The main objective for this trial was to access the correct dosage, safety, tolerability of AST-008, both when the drug is taken alone and in combination with pembrolizumab. Once the researchers achieve success with the Phase 1b/2 dosage, they would determine the correct dosage that could be used in the next Phase 2 stage.
Previously, Exicure achieved success with AST-008, which is a toll-like receptor nine (TLR9) agonist oligonucleotide, in its Phase 1 trial that was conducted on healthy volunteers. In Phase 1 trial AST successfully activated the desired immune cells and cytokines predictive for an anti-tumor effect in healthy volunteers. When used individually the drug demonstrated antitumor potential and synergized with anti-PD-1 antibodies in multiple preclinical tumor models.
Dr. David Giljohann, CEO of Exicure, said: “We believe that combining our immune system agonist drug with checkpoint inhibitors is an important strategy for leveraging the patient’s own immune system to fight cancer. We are excited to bring this approach into cancers like Merkel cell carcinoma, where patients have limited success using currently available treatments.”
In the next stage, Phase 2 study, Exicure will determine the affectivity of AST-008 in combination with pembrolizumab in patients who received anti-PD-1 or anti-PD-L1 antibody therapy but could not respond to it.