Screening for SG400 Proof of Concept Study Cohort Grant uri icon

abstract

  • Allergy and asthma represent major medical problems with significant cost to society from both quality of life and economic perspectives. Current therapies can effectively manage symptoms, but only immunotherapy has been effective in long-term down-regulation of allergic sensitivity. Our overall goal is to improve the safety and effectiveness of immunotherapy for all allergic diseases. S-TARget therapeutics GmbH (the sponsor) patented a unique molecular platform to develop allergen specific vaccines. The prototype vaccine, SG100, was directed against the allergen house dust mite antigen (a major cause of allergic asthma in humans): and in 2013, proof of concept, safety and efficacy was established by successful treatment of house dust mite allergic non-human primates at the East Carolina University (AUP Q316). Building on this and other recent successes (SG200, vaccine directed against certain types of cancers, AUP Q318), as well as recent successes and failures of immunotherapies in human clinical trials, S-TARget now uses the same molecular platform to produce SG400, the first active therapeutic vaccine against all IgE (a particular type of immunoglobulin)-mediated allergies independent of the allergen(s) that cause the disease. The goal of this project is to establish proof of concept, safety and efficacy of SG400, again in non-human primates at ECU. This will involve collection of whole blood to establish Baseline of serum immunoglobulin(s) and specific types of immune cells. Efficacy of the vaccine will be assessed via measuring changes in the serum immunoglobulin(s) and immune cell profiles after SG400 administration. Thus, the procedures involved in the study are minimally invasive (i.e., blood collection, injection of vaccine and blood collection, all under anesthesia). S-TARget vaccines SG100 and SG200 were well tolerated by Cynomolgus and Rhesus macaques, and not associated with adverse events; as was SG400 in allergic mice. Therefore, the treatments in our animals are expected to be well tolerated.

date/time interval

  • January 2018 - February 2018

contributor