Advanced Clinical Trials

The process of bringing a therapeutic to the market is a linear one, beginning with a Discovery and pre-clinical phases, progressing through Clinical Tests, and ending with Manufacturing. The MIMIC™ system by itself has an active role in the discovery and pre-clinical testing phases, helping to test new types of vaccine candidates with greater predictive power. We envision more for MIMIC™ technology, however, such as a role in adaptive clinical trials for determining inclusion or exclusion of clinic subjects.

With the Lymphoid Tissue Equivalent (LTE), we can extract the immunocytes and biomolecules it produces such as cytotoxic T cells, cytokines as well as antibodies and perform functional assays on them to see the efficacy of the various proteins and immunocytes that were created in the LTE. We can examine if they are efficacious against the disease, or if the antibodies created truly neutralize the virus.

In this way, VaxDesign is focusing its efforts on taking the MIMIC™ system and incorporating it into a functional disease assay, essentially creating a predictive clinical trial in a test tube.

Cutaway view of the interaction between the vaccination site and lymphoid tissue equivalent.

Functional assays to examine CTL responses. Click the images to view larger, more detailed versions.

Redefining Disease

In the past, a disease was defined by its symptoms. In the future, it can be defined by mechanisms of protective immunity because with MIMIC™ technology we can dissect all of those mechanisms in an in vitro way. In the past, we were focused on or assumed the uniformity of the disease; now we know that disease can be actually as heterogeneous as those infected. Using MIMIC™ models, we can test out various genetic, demographic, and age differences in a reproducible and seamless way to look at the effects of therapeutics on that individual patient.

With MIMIC™ applications, we can explore the diversity of a pathogen to the in vitro human. We'll be able to provide clinically relevant data earlier in the process, increasing the likelihood of success because we will have not only looked at the types of immune responses elicited, we'll be able to save time and when determining if it is efficacious against the disease. MIMIC™ will help us identify just those populations most susceptible to a disease, define a subsequent treatment and reduce the sample size and cost needed for effective clinical trials.