Speed and Safety in Drug Discovery  Discussion meeting 26 November 2008 9am – 5pm The Royal Society 6-9 Carlton House Terrace, London SW1Y 5AG
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Speakers' Abstracts

Prof Russell Higbee
VaxDesign, 12612 Challenger Pkwy. Orlando, FL 32826, USA.

A clinical trial in a test tube

VaxDesign Corporation has developed a Modular IMmune In vitro Construct (MIMIC™) System. This in vitro MIMIC™ System is a high-throughput robotic pipeline designed to “mimic” a basic human immune system with the capability to recapitulate human immuno-physiology to chemical formulations, adjuvants biologics, vaccines, cosmetics, drugs, and other therapeutic candidates. Thus, the MIMIC™ System is essentially a “clinical trial in a test tube.” The MIMIC™ System is based on a multidimensional interrogation of quiescent primary human cells mainly of blood origin. It is designed to rapidly simulate the individuality of a clinical trial and capture the effect of an immunotherapeutic on any human population subgroups defined by genetic diversity and other important population characteristics, such as HLA haplotypes, age and gender. We anticipate that MIMIC™ System datasets will be able help guide the design of more rapid and incisive clinical trials, and overcome limiting and misleading animal studies in predicting the immunogenic potential of non-homologous proteins and many vaccine candidates and biologicals. It is anticipated that the MIMIC™ system has the capability to provide clinically relevant information much earlier in the discovery and development process of testing adjuvants, vaccines, chemicals and biologicals, enabling a more efficient and cost-effective selection of product candidates. Isolated human immune cells are placed into engineered tissue constructs that are functionally equivalent to the physiological environment of the human immune system. This is critical for proper immune cell function and simulation of an accurate immune response and a distinct advantage of the MIMIC™ System technology over traditional industry methods such as the PBMC assay. The three-component modular MIMIC™ System contains 1) a Peripheral Tissue Equivalent module where the innate arm of the immune system plays a key role responding to chemicals, adjuvants, vaccines or pathogens; 2) a Lymphoid Tissue Equivalent module consisting of an artificial lymph node where pulsed antigen presenting cells efficiently interact with T and B lymphocytes to initiate antigen specific immune responses; and 3) function assay modules assessing neutralizing antibodies, CTL responses and hemagglutination inhibition. The immunological constructs that make up the MIMIC™ system are designed to be modular in nature. Each module can function independently as a minimal model of localized immunity against many types of compounds, adjuvants, antigens (Ags), vaccines, pathogens, etc. The modularity of the MIMIC™ System technology provides the flexibility needed during the development and characterization of novel immunotherapeutics.