JAPANESE RED CEDAR ALLERGY
JRC-LAMP-Vax is a groundbreaking immunotherapy 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 scourge but also a 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)
JRC-LAMP-VAX™ – ADDRESSING AN ALLERGY THAT AFFECTS OVER 35 MILLION JAPANESE
JRC-LAMP-vaxTM Vaccine Key Features
- JRC-LAMP-Vax, immunotherapeutic vaccine intended to treat patients with rhino-conjunctivitis caused by allergic reaction to red cedar pollen
- First immunotherapy to treat allergy that does not expose patient to free allergen
- ITI’s LAMP-vax vaccine allergy therapy is expected to require only 3 or 4 shots, not 100 or more often required for traditional, extract-based immunotherapy.
- Greatly expanded market opportunity through superior safety profile drives adoption of allergy immunotherapy by pediatricians, ENTs and GPs
- Immune response is boostable.
This vaccine has been designed and validated in two species and is now being tested in humans. ITI has completed Phase 1A and 1B clinical trials for JRC-LAMP-vax, a LAMP-based vaccine for Japanese red cedar and Japanese cypress pollen allergies. The clinical results in allergic and non-allergic Japanese patients were favorable and strongly support further development of JRC-LAMP-vax. ITI’s LAMP-vax vaccines have the potential to change the paradigm for the treatment of allergic disease. ITI is currently preparing to initiate a Phase IC clinical study in May 2014, and planning to begin Phase 2 clinical trials in late 2014/early 2015.
IMPRESSIVE CLINICAL RESULTS TO DATE
The Company sponsored a Phase I clinical study of JRC-LAMP-vax at a clinical site in Honolulu, Hawaii in 2013. The objective of the study and its primary endpoint was to establish a safety profile for our vaccine, JRC-LAMP-vax in human subjects. Twenty-four native Japanese were recruited into the study, 18 with JRC allergy as determined by skin test (the “gold standard” in determining allergic status). All 24 patients received 4 doses of vaccine with the control group (#1) and one of the test groups (#3) receiving full doses and group #2 receiving a half dose. At the end of study, we observed a remarkable conversion of skin test results from positive to negative following immunotherapy for most of the sensitive subject. As a result, we elected to continue to follow as many of these patients as possible in a Phase Ib and to evaluate the impact of providing a single booster shot. At the follow up visits, patients who were converted to skin test negative remained skin test negative and those “stragglers” who were positive at day 138 converted to skin test negative by day 220 for a 100% conversion rate. Perhaps most importantly, however, all of our safety endpoints were met.
The results of the study are given below:
In addition to the skin test data, the Company was also able to show that at the end of the study, there was a uniform and statistically valid increase in IgG over the study period while IgE levels decreased or remained at constant levels, providing important immunological confirmation of the skin test results.
WHAT COMES NEXT: CLINICAL PLANS AND PARTNERING
ITI is continuing clinical development of JRC-LAMP-Vax and is conducting a Phase IC clinical study at our Hawaii site. This is a small study using our new intradermal delivery method for JRC-LAMP-Vax, via the Biojector B2000 device, and to expand our immunological profiling. We plan to begin clinical studies with JRC-LAMP-vax in Japan in 2015.
The company believes an alliance with a pharmaceutical company will provide mutual benefits and contribute to the clinical success of JRC-LAMP-vax. The Company is currently in the final phases of discussions with a Japanese pharmaceutical company regarding a collaborative arrangement and license to develop JRC-LAMP-vax in Japan.
For more information please contact:
|Immunomic Therapeutics, Inc.|
1214 Research Blvd,
Hershey, PA 17036
15010 Broschart Road
Rockville, MD 20850