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Relief for Allergy Sufferers Finally in Sight: Immunomic Therapeutics Closes in on Treatment for Hay Fever in Japan, U.S.
Date:8/21/2014

te the impact of a single booster shot. Patients who converted to skin test negative remained negative; “stragglers” who were positive at day 138 converted to negative by day 220 for a 100% conversion rate.

ITI also showed a uniform and statistically valid increase in IgG in the study, while IgE levels decreased or remained at constant levels. This, in combination with the skin test results, hints at the vaccine’s potential. Such sweeping and rapid skin test changes haven’t been seen before in this context.

ITI is also moving forward on a study for this indication in Japan. It will meet with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan in mid August to discuss a scheduled regulatory submission for a Phase II study of JRC2*-LAMP-Vax, a bivalent CryJ1 & CryJ2-LAMP plasmid vaccine, projected to begin in Q4 2014/Q1 2015. In subsequent development and studies, ITI will continue to assess the therapeutic efficacy of the vaccine based on exposure of vaccinated subjects to red cedar pollen. In order to address the subsequent plan for development in Japan, ITI is also planning to conduct a formal consultation with PMDA.

While the studies move the world closer to a viable solution and build value for ITI, the company is in advanced stages of term-sheet negotiation with a potential Japanese partner, who will be a collaborator for development of the vaccine.

Immunomic therapeutics has brought on world-class talent as advisors to the vaccine’s development. Dr. Kimihiro Okubo, a renowned otolaryngologist and investigator with more than 100 publications on allergy, will be the Medical Advisor for clinical studies in Japan. Dr. Okubo will give ITI insight and guidance on developing vaccines in Japan and contribute to the clinical success of JRC2*-LAMP-vax.

Work done on Japanese red cedar allergy has direct impact on Mountain Cedar allergy in the United States. The two major Japanese red cedar allergens, Cry J1 & C
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