Immunomic Therapeutics Announces Filing of IND for JRC-LAMP-vax
/EINPresswire.com/ Lancaster, PA, March 26, 2012 - Immunomic Therapeutics, Inc., ("ITI,") a privately held biotechnology company announced today the submission of an Investigational New Drug (IND) application to the FDA to initiate a Phase I clinical trial of JRC-LAMP-vax™. JRC-LAMP-vax is an immunotherapeutic vaccine which is intended to treat patients with rhino-conjunctivitis caused by allergic reaction to cedar pollen, and specifically Japanese red cedar, one of the most potent and problematic pollen allergies in the world.
JRC-LAMP-vax incorporates Immunomic Therapeutics' proprietary LAMP Technology™. LAMP (Lysosomal Associated Membrane Protein) is a normal and important component of the immune system that is present in the lysosome of all mammals. Incorporating LAMP Technology into vaccine design enables direct presentation of the allergen to the immune system, resulting in an effective and dynamic response. The mechanism of LAMP has been documented in two clinical studies in cancer patients.
It is estimated that almost 45% of the Japanese population are allergic to Japanese red cedar pollen. 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 pollen, which is closely related 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 people. ITI intends to pursue the Japanese market with a partner while seeking FDA licensure for the vaccine in the U.S.
ITI's President and CEO, Dr. Bill Hearl stated, "The filing of the IND marks the third major accomplishment for the Company in the last 90 days. In addition to this important regulatory milestone, we plan to announce the closing of our Series A funding round this week. Thirdly, we established an important research and collaboration agreement with a top pharmaceutical company to develop a series of market-specific vaccines that included an upfront fee as well as future milestone and royalty payments.
This Phase I safety study is designed 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. We believe that our 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 hopes to begin recruiting patients in April and start conducting the study, in allergy clinical centers based in Atlanta, GA, this May.
About Immunomic Therapeutics
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 contact Dr. Bill Hearl, 1-717-327-1919 (phone), Immunomix @ gmail.com (email), or visit www.immunomix.com.
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JRC-LAMP-vax incorporates Immunomic Therapeutics' proprietary LAMP Technology™. LAMP (Lysosomal Associated Membrane Protein) is a normal and important component of the immune system that is present in the lysosome of all mammals. Incorporating LAMP Technology into vaccine design enables direct presentation of the allergen to the immune system, resulting in an effective and dynamic response. The mechanism of LAMP has been documented in two clinical studies in cancer patients.
It is estimated that almost 45% of the Japanese population are allergic to Japanese red cedar pollen. 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 pollen, which is closely related 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 people. ITI intends to pursue the Japanese market with a partner while seeking FDA licensure for the vaccine in the U.S.
ITI's President and CEO, Dr. Bill Hearl stated, "The filing of the IND marks the third major accomplishment for the Company in the last 90 days. In addition to this important regulatory milestone, we plan to announce the closing of our Series A funding round this week. Thirdly, we established an important research and collaboration agreement with a top pharmaceutical company to develop a series of market-specific vaccines that included an upfront fee as well as future milestone and royalty payments.
This Phase I safety study is designed 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. We believe that our 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 hopes to begin recruiting patients in April and start conducting the study, in allergy clinical centers based in Atlanta, GA, this May.
About Immunomic Therapeutics
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 contact Dr. Bill Hearl, 1-717-327-1919 (phone), Immunomix @ gmail.com (email), or visit www.immunomix.com.
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