Idaho Immun is focused to superantigen therapy - work which came out of research done on Staphylococcus aureus - the organism which causes toxic shock syndrome and staphylococcal food poisoning. Staph aureus causes these diseases because it makes a special kind of toxin known as a superantigen. This superantigen has a uniquely unfortunate characteristic in that it turns off a person's immune system causing immunosuppression. Superantigens are also involved in animal disease by causing the same immunosuppression seen in humans. Staphylococcal mastitis found in cows is a very significant disease because it causes the milk to become infected as well as the cow. The reason the animal cannot fight off the disease is because the toxin is immunosuppressive. It turns off the normal immune response at that sight. Once the structure of the molecule was established, principals of the firm were able to create a new molecule that retained all of the good immunostimulatory factors but all of the toxicity and immunosuppression was removed. Following patenting, principals judged this modified superantigen should be used in animals for mastitis. Phase I generated good data but the renewal grant was denied. Through a colleague in Korea, Dr. Park, they established a cooperation with LG Life Sciences who funded about $300,000 worth of animal trials in South Korea that confirmed everything that was shown with the SBIR grant and have since funded larger trials that are going on at Washington State University. The modified staph aureus molecule is not operating based only on staph aureus diseases. But is a non-specific augmentation of the immune response that can be used more broadly, possibly as an anti-cancer therapy or to protect the population against terrorist threats. In collaboration with a California company, JenQuest, Inc., a clinical trial on a form of lung cancer showed that patients who received the superantigen therapy lived substantially longer with this treatment. Superantigen therapy can also be useful in bioterrorism. The organism Y. pestis (the causative agent of plague) is very deadly and needs to be handled in a BSL-3 containment facility which the University of Idaho has. If one bacterial cell of this organism is inhaled, death will occur within one to four days. Animal trials being done with mice show that 60% of the animals that receive therapy are alive up to 14 days after exposure.
