AST-VAC1 was previously tested in a multi-center, open-label, Phase 2 clinical trial in patients with intermediate and high risk AML. Primary objectives and endpoints were the feasibility of manufacture of AST-VAC1, along with the safety and tolerability of the vaccine in patients with AML in complete remission at screening. Long term follow up of Phase 2 clinical results [link to ASCO presentation] demonstrated that 57% of patients over 60 years of age receiving AST-VAC1 were still in complete remission at 52 months. This compares very favorably to historical data from multiple sources indicating 4 year relapse-free survival rates of 10-20% in this population.
The AST-VAC1 treatment is well tolerated with safety established through both phase 1 and phase 2 trials. The phase 1 study of metastatic prostate cancer patients found no major treatment related toxicities or any autoimmune pathology. In the phase 2 trial of AML patients, there was only one significant adverse event deemed possibly related to treatment.
We are currently performing process development of our AST-VAC1 manufacturing process in preparation for a confirmatory Phase 2b study designed to reproduce these results in a larger, randomized trial.