August 21st, 2014
ITI moves one step closer to a solution for the worldwide allergy crisis
DNA vaccine pioneer Immunomic Therapeutics, Inc.(ITI) is making progress in its development of JRC-LAMP-vax, an innovative and safe potential treatment for allergy to Japanese red cedar pollen. Phase IC studies began this month in Hawaii, moving the world closer to a real solution to hay fever.
The Japanese red cedar releases pollen that causes devastating allergies in over 35 million people in Japan. Mountain Cedar pollen wreaks similar havoc in Colorado, New Mexico and Texas during late winter and early spring.
Until now, effective and lasting solutions to these allergies have been elusive. Immunomic Therapeutics has emerged with a new class of DNA-based allergy immunotherapeutic vaccines, based on their breakthrough LAMP technology, that could end the suffering and bring worldwide relief.
The Phase IC study will explore the safety profile of the JRC-LAMP-vax vaccine, delivered intradermally using the Biojector B2000, and will continue immunological profiling. Japanese expatriates have been recruited, screened and successfully dosed.
The Biojector® B2000 is a needle-free jet injection system approved by the FDA to deliver vaccines intramuscularly, subcutaneously and intradermally. Studies show the device is safe and provokes a better immune response. ITI seeks to validate B2000 ID as part of the JRC-LAMP-vax treatment regimen.
ITI already completed two clinical studies with JRC-LAMP-vax that validated the vaccine’s safety and immunological activity. The Phase IA study established a safety profile for humans. While safety endpoints were met, ITI saw remarkable conversion of skin test results from positive to negative after vaccination. They followed the patients in a Phase IB to evaluate 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 & Cry J2, are highly homologous and cross-react with the corresponding allergens in Mountain Cedar (Jun a1 & Jun a2). Therefore, ITI’s work in JRC-LAMP-vax is applicable as a therapeutic vaccine to treat the Mountain Cedar allergy. Following on the heels of JRC2*-LAMP-vax over the next few years, ITI will be working on the Mountain Cedar indication. The next step will be to conduct a Mountain Cedar clinical trial at an allergen exposure chamber in San Antonio, Texas. The study will test the efficacy of the vaccine against Mountain Cedar allergy.
ITI leadership predicts that, within several years, it can begin to tackle even more worldwide allergy problems with a multi-valent vaccine. LAMP-vax will represent a breakthough in allergy immunotherapy, as well as in the DNA vaccine landscape.