A recent article in the journal Nature reports that Phase 1 GAPVAC-101 First-In-Human trial is one of the first clinical trials with a goal of designing and manufacturing actively personalized vaccines (APVACs). This new type of immunotherapy involves treating patients according to the characteristics of their immune system and tumors.
A New Approach
The definition of personalized medicine, as set forth by the National Cancer Institute, is “a form of medicine that uses information about a person’s genes, proteins and environment to prevent, diagnose and treat disease.” While treating a patient with cancer, specific information about a tumor aids in the diagnosis, treatment and/or prognosis.
The majority of therapies approach tumors by using the same method for many other tumors. However, each tumor generally differs from others. Using similar therapies without accounting for these differences will diminish the efficacy of the treatments.
There are many terms used for personalized medicine such as precision medicine, personal genomics or associated diagnostics. These individualized treatments may involve targeting certain cancer cell types or testing tumor markers for diagnostic purposes.
About the Phase I GAPVAC-101 Study
The researchers designed the study to target glioblastoma, an aggressive form of brain cancer that does not respond to conventional therapies. Its five-year survival rate is 6%.
The idea for GAPVAC was conceived years ago, but the designers were told that it wouldn’t be possible to implement. The fact that they were able to overcome the complexities of conducting such a unique clinical trial is extraordinary.
The Glioma Actively Personalized Vaccine Consortium (GAPVAC) project is the first trial to design and manufacture APVACs. The project involves a series of innovations featuring medication for each patient that is manufactured on-demand.
The 15 glioblastoma patients who volunteered for the trial were newly diagnosed and treated with two therapeutic vaccines sequentially. The initial vaccine (APVAC1) was focused on non-mutated antigens (antigens are substances that can stimulate an immune response). The second vaccine (APVAC2) was aimed at newly formed antigens (called neo-antigens).
The researchers focused on the tumors’ mutations, molecular composition, and whether the patient showed an immune response.
About the Results
The vaccines were individualized through various aspects of the patient’s tumors and they successfully evoked immune system responses. The researchers were able to demonstrate that it’s feasible to move forward with personalized medicine.
However, one major drawback is the length of time that it takes to manufacture the drugs. The time, measured from diagnosing the tumor to application of the drug, can be anywhere from three to six months depending on the mode of therapy and targets. The researchers agree that this aspect of the process must be improved.
Still, researchers believe in personalized immunotherapy holds great promise, and will eventually become a reliable treatment for cancer patients.