Filing an IND for a Phase II Study, ITI is Moving Closer to Solutions for Allergy

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ITI has submitted a new IND for a Phase II clinical study of the JRC Vaccine

Dr. William Hearl

We are making significant strides in building value for our investor community, future pharmaceutical partners and patients, applying our breakthrough LAMP technology to the treatment of allergic disease - Dr. Hearl

DNA Vaccine pioneer Immunomic Therapeutics, Inc. (ITI), a privately held biotechnology company, submitted a new Investigational New Drug (IND) Application to the FDA on September 10th. This is for a Phase II-Japan Safety and Proof of Concept Chamber Study of JRC2*-LAMP-vax, a bivalent vaccine which is composed of separate vectors for pITI-CJ1-LAMP-vax and pITI-CJ2-LAMP-vax.

This protocol will compare two vaccine delivery methods, intramuscular (IM) and intradermal (ID), using an allergen challenge chamber to assess symptom changes. ITI plans to use the results from this study, which will take place in Japan, to support future clinical studies in the United States.

Immunomic Therapeutic, Inc. has developed the JRC2*-LAMP-vax vaccine to mitigate allergies to Japanese Red Cedar. LAMP-vax allergy vaccines may also be applied in the future to Mountain Cedar. The Japanese red cedar tree releases pollen that causes devastating allergies in over 35 million people in Japan. On the other hand, Mountain Cedar pollen wreaks similar havoc in Colorado, New Mexico and Texas during late winter and early spring. However, there still is is no effective, long lasting, and developed medication that can provide help to these allergic subjects.

As a result of submitting IND for the Phase II study, ITI is a step closer to the start of a Phase II clinical trial which is planned to be held in Japan after the IND submission is reviewed and authorized by the FDA.

Dr. William G. Hearl, CEO of Immunomic Therapeutics, Inc., stated: “This recent submission is another accomplishment in a long list of recent milestones achieved by our clinical and regulatory team. As a result of this IND submission, ITI is yet one step further along in beginning our Phase II clinical study in Japan in Q4 2014. As a clinical stage company in Phase II studies, we are making significant strides in building value for our investor community, future pharmaceutical partners and patients, applying our breakthrough LAMP technology to the treatment of allergic disease.”

With this new IND submission for the Phase II clinical trial, ITI is moving towards the solution to Japanese red cedar allergy in the US. However, the company is broadly moving one step closer to a possible solution for the allergy crisis not only in Japan, but also in the US and possibly worldwide. Within several years, the Company could take even bigger steps to erradicate the allergy problem with a multi-allergen vaccine. Thus, JRC2*-LAMP-Vax represents a breakthorugh in allergy immunotherapy, as well as an important play in bringing success and recognition to the DNA vaccine industry.

About Immunomic Therapeutics, Inc.
Immunomic Therapeutics, Inc. (ITI) is a privately held clinical stage biotechnology company headquartered in Lancaster, PA with lab facilities in Rockville, MD. ITI is developing next generation vaccines based on the patented LAMP Technology. Our LAMP-Vax platform significantly increases the effectiveness of the immune response to nucleic acid vaccines while simplifying overall vaccine design and delivery, yielding safer, more cost-effective human and animal therapies. Our LAMP constructs have been validated in human clinical trials for cancer and have been applied to a wide breadth of targets including allergy, cancer and infectious diseases. For more information about ITI and LAMP Technology please visit http://www.immunomix.com

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