LOUISVILLE, Colo., September 4, 2013 – GlobeImmune, Inc., announced today that it has been awarded a $4 million Research Project Grant (R01) by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to support the development of Tarmogen® immunotherapy products to treat and prevent tuberculosis infection.
The research project under this R01 grant will be a collaborative effort between GlobeImmune and Dr. Ian Orme, Ph.D., University Distinguished Professor in the Department of Microbiology, Immunology & Pathology at Colorado State University (CSU). The goal of this project is to develop novel Tarmogen immunotherapy products with the potential to prevent drug resistant forms of tuberculosis in the pre- and post-exposure setting, as well as to treat active tuberculosis infection.
This project will combine Dr. Orme’s expertise and unique animal models in tuberculosis with GlobeImmune’s expertise in the preclinical and clinical development of its proprietary Tarmogen platform technology. Importantly, this collaboration will test Tarmogen product candidates against newly emerging, highly virulent, multi-drug resistant clinical strains of Mycobacterium tuberculosis in small animal models designed to be more predictive for the disease.
“Tarmogen products have been shown to generate a unique T cell immune response that appears to be critical in the control of pathogens like tuberculosis,” said Dr. Orme. “This immune response could therefore be a highly effective strategy for targeting this disease using new vaccines. Currently, we badly need new strategies given the disappointing results from a recent major clinical trial. By triggering new immune pathways with GlobeImmune’s innovative technology, we may be able to develop far more effective vaccines.”
Timothy C. Rodell, M.D., Chief Executive Officer at GlobeImmune and Principal Investigator on the grant, said, “Dr Orme is a preeminent tuberculosis researcher who will be a significant intellectual resource for this work, and we are delighted to be working with his team at Colorado State University on this project.”
Tuberculosis (TB) caused by Mycobacterium tuberculosis infection remains a major cause of death and morbidity worldwide, with over two million deaths annually, ranking in the top three etiologies of infectious disease mortality globally, along with HIV/AIDS and malaria. In addition an estimated 2 billion people worldwide have latent M. tuberculosis infections. The number of new cases worldwide is higher than at any other time in history, occurring at a rate of one every three seconds for an annual incidence of over 9 million. Of these, over 650,000 cases are multidrug resistant.
M. tuberculosis is both an intra- and extra-cellular bacteria. Following infection, most immunocompetent individuals (~90%) either eliminate TB or contain it chronically in a latent state, where the host immune system retains sufficient control over bacterial replication such that the individual remains free of tissue damage and symptoms. Currently, patients that develop active TB are treated with various combinations of antibiotics to reduce the risk of resistance. Unfortunately, however, over the past two decades multi-drug resistant (MDR), extensively resistant (XDR) and totally drug resistant (TDR) forms of tuberculosis have emerged. Treatment options for patients with these forms of tuberculosis are both very expensive and extremely limited.
GlobeImmune is a biopharmaceutical company focused on developing products for the treatment of cancer and infectious diseases based on its proprietary Tarmogen platform. Tarmogens activate the immune system by stimulating cellular immunity, known as T cell immunity, in contrast to traditional vaccines that predominately stimulate antibody production. To date, Tarmogen product candidates have been generally well tolerated in clinical trials for multiple disease indications and are efficient to manufacture. In May 2009, the company entered into a collaboration agreement with Celgene Corporation focused on the discovery, development and commercialization of product candidates for the treatment of cancer. In October 2011, the company entered into a worldwide, strategic collaboration with Gilead Sciences, Inc., to develop Tarmogens for the treatment of chronic hepatitis B infection. For additional information, please visit the company’s website at www.globeimmune.com.
Safe Harbor Statement
This press release contains “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential for Tarmogens to target tuberculosis, Tarmogen potential side effect profiles, the Company’s ability to successfully complete clinical trials, timing and eventual prospects for approval to market any of the Company’s products and the prospects for the Company’s collaborations. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. The Company disclaims any intent or obligation to update these forward-looking statements.