JAPANESE RED CEDAR VACCINE
About Japanese Red Cedar and JRC-LAMP-Vax™
ITI's lead product, JRC-LAMP-Vax™, is currently being used in clinical trials. JRC-LAMP-Vax is a plasmid-based immunotherapeutic for treatment of patients suffering with allergies to Japanese cedar pollen, one of the most potent and problematic pollen allergies in the world.
The Japanese red cedar tree is a national cultural symbol in Japan. It is estimated that 25%-50% of the Japanese population, more than 35 million individuals, are allergic to Japanese red cedar pollen. For more information on the Japanese Red Cedar tree and the allergy it creates, please see ITI's publication: “Beauty and the Beast”
In North America, Japanese red cedar is an ornamental tree with pockets of growth in North Carolina, East Texas and Oklahoma. However, many individuals in Western states suffer from allergic rhinitis to mountain cedar, whose pollen allergens are structurally similar to the allergens from Japanese red cedar pollen. Allergic rhinitis is one of the most chronic diseases in the US, affecting up to 40 million Americans. ITI intends to pursue the Japanese market with a commercial partner, while seeking FDA licensure for the vaccine in the U.S.
Animal and human clinical studies have documented that LAMP DNA vaccines induce a protective antibody immune response consistent with a preferential MHC-II immune system presentation induced by the LAMP component. Previous research has specifically indicated that LAMP in the DNA vaccine molecule induces IgG protective antibodies and greatly diminishes the production of the allergy antibody, IgE. This represents a shift of the immune response to the vaccine from Th2 to Th1, the underlying concept for classic allergy desensitization. This re-education of the immune system response is the basis of the medically accepted paradigm for treating allergy by conventional allergy immunotherapy.
In March 2012, ITI successfully submitted an Investigational New Drug (IND) application to the FDA to initiate a Phase I clinical trial and received authorization to proceed with it in April, 2012. ITI has completed dosing for the open label, Phase I, clinical study. This study wasdesigned to establish the safety of the LAMP-vax platform and to provide important immune response data as it applies to allergy patients. This is the first immunotherapy platform that treats the patient without introducing any free allergen or allergen component. This approach will help the immune system react to the targeted allergens with a non-allergenic response, resulting in desensitization in highly allergic subjects in a safe and effective manner.
Immunomic Therapeutics will be initiating a subsequent Ph I/II study of JRC-LAMP-Vax. The study will be conducted in clinical centers in the US.
JRC-LAMP-vax™ Vaccine Key Features
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