Validation of the MIMIC™ System

The success of MIMIC™ technology hinges on its ability to support the generation of antigen-specific immune responses that mimic normal human immunophysiology. We are examining a multi-faceted approach to validate and demonstrate the sensitivity, reliability and predictability of this in vitro system. First, we plan to validate our advanced in vitro artificial immune system model, complete with relevant cells and 3D microenvironment necessary to recapitulate a human immune response. For this, we are seeking commercial partners for validation and proof-of-concept demonstrations of the sensitivity, reliability, and predictability of our model using successful and failed vaccine candidates.

The first charge is to use commercially available vaccines to test in the MIMIC™ system. Our goal is to hone and validate the MIMIC™ technology by comparing the data we generate in vitro against the results these groups attained in vivo, or that can be gleaned from the literature. The physiologic relevance of MIMIC™ technology should be revealed in studies comparing the performance of pre- and post-vaccination PBMC in vitro with data obtained from the same patient in direct in vitro experiments. Finally, we can examine the immunostimulatory potential of commercially available vaccine formulations in MIMIC™ and compare the outcomes of these experiments against published clinical results.

It is critical to couple the MIMIC™ model to human immunology and in vivo experiments. Our driving force is to move towards experiments and technologies that produce better quality data rather than simply more data. This issue's importance is growing in the pharmaceutical industry where there often now seems to be a negative correlation between R&D investment and productivity. A major advantage of the in vitro MIMIC™ model for our strategic partners will be early adoption of MIMIC™ technology as well as the rapid turn-around time for analysis, allowing decision-making from sophisticated, predictive, multi-endpoint data.

In addition to commercial vaccines such as tetanus, influenza, and HBV, validation vaccines have been selected due to their importance in public health and because they represent a broad spectrum of vaccine technologies: subunit HIV gp120 and 140; attenuated live virus (yellow fever); DNA based vaccine (yellow fever); and an inactivated vaccine (Hepatitis A). We choose these vaccines since they provide a broad spectrum of vaccine technologies ranging from a subunit to a polynucleotide to a live attenuated to an inactivated formulation.