The diversity of potential targets and therapeutic modulators that will emerge from the VLST discovery platform provides the potential to treat a number of possible clinical indications. These include different autoimmune and inflammatory disorders, orphan diseases, rheumatoid arthritis, psoriasis and multiple sclerosis, and conditions known to have an immune or inflammatory component to their etiology, such as the complications of acute viral infections, transplant rejection and asthma. 

The VLST process for product development includes: the application of bioinformatics & proteomics to identify virulence factors; the determination of cellular targets; the identification of human homolgues or the generation of monoclonal antibodies that mimic the virulence factor function; testing in animal models; and advancement into the clinic. In selecting product candidates to advance into further development, VLST will consider several critical determinants including, clinical need, mechanism of action, clinical development timelines, side effect profile and potential market opportunity.

Product Candidates

Through its laboratory operations, VLST has identified and cloned over 70 novel virulence factors and, utilizing the VLST discovery platform, identified the host targets for 9 of these virulence factors.  Three programs have been selected to move forward into preclinical development.  For each of these programs, viral knock outs of the virulence genes confirm their ability to function as suppressors of the immune system in vivo.

The VLST preclinical group has developed a wide variety of in vitro assays to assess the immunomodulatory potential of lead therapeutic candidates.  Validation of immunomodulatory activity in these human in vitro assays will allow for prioritization of the most promising therapeutic candidates for in vivo evaluation.

In vivo studies designed to evaluate the efficacy of potential therapeutic candidates in inflammatory and autoimmune diseases are also underway.  The studies will address increasingly complex criteria relevant to eventual testing in the human clinical setting.  These include: development of bioassays for potency and biomarkers for monitoring therapy; evaluation of bio-availability; evaluation of ability to modulate acute inflammatory processes; and determination of ability to modulate complex, chronic inflammatory and autoimmune diseases.