"We reduced the allergy in just four doses delivered over four weeks, where several other approaches require a once-a-day peanut protein treatment for more than a year," says Dr. Teri Heiland, ITI’s Vice President of Research and Development.
Hershey, PA & Rockville, MD (PRWEB) June 17, 2014
Vaccine leader Immunomic Therapeutics, Inc. (ITI) announced that it has successfully completed a model animal therapeutic and prophylactic study protocol for ARA-LAMP-vax, a breakthrough treatment that mitigates peanut allergy.
The milestone brings the company one step closer to an immunotherapy that could eradicate peanut allergy, one of the leading causes of death from food reactions. More than 1.5 million children suffer from a peanut allergy, and the cost to treat them has soared past $25 billion.
“This is an exciting development that may finally lead to a product to treat peanut allergy and eliminate the daily fear and unintended consequences of accidental exposure,” said Dr. Teri Heiland, ITI’s Vice President of Research and Development. “So many children are just a bite away from a potentially deadly allergic reaction. The world needs a solution, and completion of this study and external validation of the product puts us right on the doorstep of clinical validation of this breakthrough treatment.”
The ITI vaccine uses patented LAMP technology to educate the immune system to not react against peanut proteins with an inflammatory response.
An allergic person’s immune system develops an inflammatory response when it interacts with peanut proteins, causing the production of large quantities of Immunoglobulen E (IgE) antibodies that attach themselves to mast cells and basophils throughout the body. This sensitizes the body to peanut exposure and results in hypersensitivity or allergic reaction.
The ITI treatment delivers information about the peanut allergens to the body using LAMP-vax technology. It eliminates the need to expose the patient to even the minutest amounts of peanut protein. The process effectively reorients TH1 and TH2 cell activity to reverse the allergic reaction.
When ARA-LAMP-vax was applied in a peanut allergy model, the study found that peanut allergy was greatly reduced with four doses. Pre-treating animals with the vaccine prevented development of a peanut allergy altogether.
“We reduced the allergy in just four doses delivered over four weeks, where several other approaches require a once-a-day peanut protein treatment for more than a year,” says Dr. Heiland. “Those protocols expose patients to the allergen, so there’s a risk for allergic reaction. Our LAMP technology eliminates that risk because patients are not exposed to free peanut antigen.”
With the study complete, ITI is preparing to bring the product into the clinic. Animal studies will continue in an effort to optimize the vaccine with different routes of administration and treatment schedules for long-term protection. It is worth noting that ITI safely completed a Phase I study using the same LAMP-vax technology applied to cedar pollen. In that study, 100% of the allergic subjects showed reversal of skin test reactivity to the cedar pollen.
The company expects to be ready for manufacturing and subsequent preclinical bio distribution/toxicology testing in early 2015. Study design for the Phase I clinical trial is being finalized, with a goal to enter clinic with this potentially game-changing therapy in 2015.
About Immunomic Therapeutics
Immunomic Therapeutics, Inc. (ITI) is a privately held clinical stage biotechnology company dedicated to pioneering vaccines that transform lives. It is headquartered in Hershey, PA with lab facilities in Rockville, MD. ITI develops next-generation vaccines based on patented LAMP Technology. Its LAMP-vax™ vaccine platform significantly increases immune response to nucleic acid vaccines and simplifies vaccine design and delivery for safer, more cost-effective therapies. Its LAMP constructs have been validated in human clinical trials for cancer and have been applied to targets like allergy, cancer and infectious diseases. For information about ITI and LAMP Technology, visit http://www.immunomix.com.