Press Release
For Immediate Release Immunomic Therapeutics Prepares to File for Pre-IND Meeting on JRC LAMPvax, an Immuno Therapeutic Vaccine for Allergy
Gaithersburg, MD, Novermber 17, 2008 — Dr. Bill Hearl, President and CEO of Immunomic Therapeutics, Inc., Gaithersburg, Maryland, announced today that the Company will be filing in early October a pre-IND meeting request to the Center for Biologic Evaluation & Research (CBER), FDA for discussing a Phase I clinical safety study of its JRC LAMP-vax allergy vaccine in twelve (12) patients suffering from Red Cedar (Junperius virginiana) induced allergic asthma, preferably before the end of 2008. This allergic condition is particularly debilitating as an occupational disease in saw mill workers in Texas, which cut red cedar trees into planks, and also as seasonally in the general population in Southwestern US. The concept of starting the study in Texas with saw mill workers suffering from severe allergy reactions will enable an immediate study initiation that is not dependent on allergy seasonal levels. The proposed Phase I study will utilize a LAMP vaccine, which contain the same allergen sequences, Cry J1 and Cry J2, as in Japanese Red Cedar, allergic condition that is also particularly debilitating in over 50 million Japanese patients with JRC allergy. (see http://www.immunocapinvitrosight.com) ITI is now discussing partnering of its Red Cedar JRC LAMP-vax vaccine with several Japanese Pharmaceutical companies. Immunomic Therapeutics, Inc., will be providing CBER with its preclinical and clinical development plan to initiate the Phase I by the end of 2009. The proposed allergy vaccine vector construct is based proprietary lysosomal associated membrane protein (LAMP) technology developed by Dr. Thomas August, Johns Hopkins University, which has already been studied in mice, in non-human primates and in human patients. The LAMP-vax vaccine induces the cytoplasmic expression of lysosomal associated membrane protein fused to the allergen protein (a chimeric protein), which through the LAMP preferentially migrates to the major histocompatibility complex II (MHC-II)/ Th1 pathway. ITI’s LAMP-vax vaccine utilizes this intracellular trafficking function to convert the existing atopic IgE immune response into IgG (protective antibodies) response, which is the primary therapeutic paradigm that allergists try to achieve during allergy desensitization. The structure of the LAMP-allergen chimera protein offers a unique feature in that the allergen is encased in the LAMP and limited to the lysosomal compartment; thus, eliminating circulating free allergen. The LAMP-vax vaccine will contain two plasmids, each containing a different allergen sequence. Prior discussions with FDA on another LAMP-vax product indicated that FDA would accept LAMP-vax vaccines containing up to six plasmids as a single product. ITI believes that a future LAMP-vax allergy vaccine could contain up to six different allergen antigen sequences to give it a very broad therapeutic capability in a single treatment. # # # About Immunomic Therapeutics Immunomic Therapeutics, Inc. (“ITI”) is a privately held biotechnology company headquartered in Gaithersburg, Maryland that is commercializing DNA vaccines that are important to human health. ITI’s vaccines utilize its proprietary LAMP Technology and have been shown to enhance the immune response in human clinical studies. LAMP vaccines are currently in or preparing for clinical studies for cancer (AML and prostate cancer), therapeutic HIV, allergy and influenza. More information about ITI and LAMP technology can be obtained from www.immunomix.com.
Immunomic Therapeutics, Inc. 920 Gaither Road, Gaithersburg, MD 20877 P: 240-731-5232 F: 240-597-4061 www.immunonix.com
This press release may contain forward looking statements regarding, among other matters, the Company's future prospects. Forward looking statements address matters that are subject to a number of risks and uncertainties that can cause actual results to differ materially. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of ITI’s technologies, constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Future results of the Company will depend on a variety of factors, including the timing of significant orders, the ability of the Company to timely manufacture and deliver ordered products, the ability of the Company to bring new systems to market, the timing of new product releases by the Company's competitors and other competitive factors.
CONTACT: Bill Hearl, Ph.D., President & CEO Immunomic Therapeutics, Inc. 240-731-5232 info@immunomictherapeutics.com