A Warm WELCOME!

Welcome to the ITI LAMP LIGHT Blog for the Immunomix investor communities. Here you will find a focus on progress being made at ITI – and elsewhere – using LAMP in clinical and biomedical research for humans and animals.  As we make progress towards commercialization, you’ll be able to follow from the investor’s perspective.

Learn more About Lamp.

Learn more About LAMP-vax Clinical Trials.

Learn more about ITI management.

Learn more about ITI

Learn more about Allergies

Learn more about Japanese Red Cedar Allergy

Learn more about Peanut Allergy

 

Immunomic Therapeutics Receives Chimeric LAMP Vaccines US Notice of Patent Allowance, Key to LAMP-Vax Vaccines 

Lancaster, PA, & Rockville, MD August 2nd, 2012 – Immunomic Therapeutics, Inc., (“ITI,” Lancaster, PA) a privately-held biotechnology company with laboratories in Rockville, MD, announced that the U.S. Patent and Trademark Office is providing a Notice of Allowance for ITI’s “Chimeric Vaccines” patent in the US. This protection specifically covers vectors utilizing the company’s proprietary Lysosomal Associated Membrane Protein (LAMP) LAMP DNA vaccine platform, the core design and technology utilized in ITI’s improved LAMP-based DNA vaccine vectors being applied in the company’s R&D pipeline and clinical studies. This allowance rounds out ITI’s worldwide chimeric patent portfolio including allowances in Europe, Japan and Australia.

ITI’s VP of R&D, Dr. Teri Heiland, explained, “The invention covered under this patent represents a unique innovation in DNA vaccines.  Specifically, our improved LAMP vector allows us to generate an enhanced immunological response in comparison to other DNA vaccine technologies.  This Notice of Allowance represents a great day for the LAMP vaccine platform technology and ensures protection of our LAMP technology until 2022.”

CEO, Bill Hearl, Ph.D., offered, “this US patent allowance is part of an integrated strategy to commercialize a growing pipeline of leading DNA vaccine platform Intellectual Property currently fueling ITI’s emerging LAMP DNA vaccine businesses.”

The Chimeric Vaccines invention provides for chimeras of proteins and nucleic acids to generate vaccines against selected antigens. The chimeras encode antigenic sequences and domains for trafficking to an endosomal compartment, directing the antigenic protein to the MHC-II compartment in the cell, promoting enhanced immune response.

LAMP technology has demonstrated highly promising results at the research level and is being aggressively commercialized by ITI under exclusive worldwide license from Johns Hopkins University and its original inventor, Distinguished JHU Professor Dr. J. Thomas August, M.D.

Immunomic Therapeutics is currently implementing LAMP in the clinic with an investigational allergy vaccine for the treatment of rhinocinjunctivitis to Japanese Red Cedar. ITI will begin an open label, Phase I, clinical study designed to establish the safety of the LAMP-vax platform. The primary objective of this Phase I Study is to evaluate both the safety and immunological response of therapeutic doses and the dosing regimen of JRC-LAMP-Vax vaccine as it applies to allergy patients.   The study, to be conducted in allergy clinical centers based in Atlanta, Baltimore and/or Los Angeles is expected to be begin in the Summer of 2012.

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Beauty & The Beast

Beauty & The Beast

A visually stunning piece on the Japanese red cedar tree, it’s historical and cultural significance and the widespread allergy problem it causes in Japan

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ITI Receives IND Authorization from FDA for Phase I Study of Japanese Red Cedar LAMP-vax Vaccine

Lancaster, PA, & Rockville, MD May 2, 2012 – Immunomic Therapeutics, Inc., (“ITI,” Lancaster, PA) a privately-held biotechnology company with laboratories in Rockville, MD, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug Application (“IND”) filed for the allergy immunotherapy, JRC- LAMP-vax™. On April 12th, the FDAnotified ITI that there will be no clinical hold and that ITI may now proceed with its clinical trial in June for JRC-LAMP-vax in Atlanta with subjects sensitive to Japanese Red Cedar pollen.

JRC-LAMP-Vax is a plasmid-based DNA vaccine that will be studied for the treatment of patients with rhino-conjunctivitis (runny nose) symptoms caused by allergic reaction to Japanese red cedar pollen. Almost 45% of the Japanese people are allergic to Japanese red cedar pollen. In North America, there is allergic rhinitis to mountain cedar pollen, which is 80% cross-reactive with Japanese red cedar pollen allergen. ITI intends to partner with a Japanese pharmaceutical company for studies in Japan and will seek FDA approval of the vaccine in the US.

ITI provided FDA with animal studies of JRC-LAMP-Vax, showing no alteration of the routine clinical pathology, body weight, food consumption, temperature, ophthalmology, dermal irritation or the histopathology of any tissue examined microscopically. Overall, JRC-LAMP-Vax caused no abnormal safety issues in bio-distribution and toxicology studies in animals. This data was consistent with other reported animal and human studies of components of its vaccine.

Animal safety studies and human clinical studies have documented that LAMP DNA vaccine induces a protective antibody immune response consistent with a preferential MHC-II immune system presentation induced by the LAMP component. LAMP-based vaccines hold potential for the development of potent vaccines for treatment of allergies, infectious disease and cancer.  Previous research has specifically indicated that LAMP in the DNA vaccine molecule induces IgG protective antibodies and greatly diminishes the production of the allergy antibody, IgE. This represents a shift of the immune response to the vaccine from Th2 to Th1, the underlying concept for classic allergy desensitization. This re-education of the immune system response is the basis of the medically accepted paradigm for treating allergy by conventional allergy immunotherapy.

Dr. William G. Hearl, CEO of Immunomic Therapeutics, Inc., stated, “The IND authorization is the result of the long-term commitment and support of ITI and the continuous efforts contributed by its researchers and regulatory team.  It cannot be overstated what a significant accomplishment this is for our Company. The expeditious FDA review and approval of our Phase I study plan is a testament to a strong scientific foundation and well-planned regulatory strategy.”

ITI has begun enrollment for the open label, Phase I, clinical study designed to establish the safety of the LAMP-vax platform and to provide important immune response data as it applies to allergy patients. The study will be conducted in allergy clinical centers based in Atlanta, GA and is expected to begin in 3rd Quarter 2012. The primary objective of this Phase I Study is to evaluate both the safety and immunological response of therapeutic doses and the dosing regimen of JRC-LAMP-Vax vaccine.

 

 

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“Understanding the Immune System” Resource Now Available.

As part of the LAMP Light mission, we will be adding appropriate resources for our Investor Communities to help enhance their literacy in the topic of Vaccine Immunology. “Understanding the Immune System. How It Works” (pdf) is a great place to start your introduction to Immunology.

COURSE SYLLABUS
This publication from the National Institutes of Health covers all the main topics including antibodies, T-cells, B-cells, IgG, IgE and natural versus acquired immunity – and of course, allergy. It will open in a new window, so be sure your pop-up blocker is turned off. A better way to view this is with our Issuu Reader. A new web feature, this page turning technology makes presentations & publications a pleasure to read on your monitor. Just click on THIS LINK and enjoy!

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LAMP Light™

Welcome to the LAMP Light Blog for Immunomix investor communities. Here we’ll focus on the progress being made at ITI – and elsewhere – using LAMP in biomedical research for humans and animals.  Learn more About Lamp.

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