If successful, these drugs could be used alone or in combination with other drugs, giving multibillion dollar sales potential. Other autoimmune diseases that IMNR may seek to target are Rheumatoid arthritis and Psoriasis.
For a detailed understanding of this biotech company review the presentation that was given by Immune Response President and CEO, Dr. Joseph O’Neill, in New York to retail and institutional investors. It can be viewed at http://www.imnr.com/ir/2006APR19.htm
Joseph F. O’Neill, M.D., M.S., M.P.H. is the president and CEO of The Immune Response Corporation. Dr. O’Neill has spent the past five years in AIDS related research. Before joining the Company he served as Deputy U.S. Global AIDS Coordinator and Chief Medical Officer for the Office of the Global AIDS Coordination at the U.S. Department of State (from August 2003 to August 2005). Dr. O’Neill’s move to the State Department followed his position as Director of the White House Office of National AIDS Policy (from July 2002 to August 2003).
Dr. O’Neill was chief architect of the President’s 2003 Emergency Plan for AIDS Relief, known as PEPFAR, a $15 billion U.S. Government led global initiative to combat the HIV/AIDS epidemic. He also coordinated the successful legislative strategy resulting in the passage by Congress of the U.S. Leadership against HIV/AIDS, Tuberculosis, and Malaria Act of 2003.Before his White House position, Dr. O’Neill served as the Acting Director of the Office of HIV/AIDS Policy in the Department of Health and Human Services, coordinating the Department’s $30 billion HIV/AIDS program.
Dr. O’Neill holds degrees in business administration, public health, and health and medical sciences from the University of California at Berkeley. He graduated from the University of California, San Francisco School of Medicine and is a practicing HIV/AIDS physician and a member of the faculties of the Johns Hopkins School of Medicine and the University of Maryland School of Medicine. He was previously on the medical staff of the Chase Brexton Clinic, a community based AIDS clinic in Baltimore.
Successful commercialization of discoveries championed by Immune Response would be a groundbreaking advance in the treatment of these diseases. Therapies in development at IMNR are based on using the immune system to treat diseases. This includes two autoimmune diseases: HIV/AIDS, multiple sclerosis (MS). These therapies include other autoimmune diseases as well.
Immune Response Maintains Its Own Manufacturing Facility
Immune Response has its own state-of-the-art manufacturing plant in King of Prussia, Pennsylvania, to make IR103 and NeuroVax for clinical trials. This is one of the few facilities in the world that can produce large quantities of live HIV vaccines.
Peter Lowry, Vice President of Manufacturing, is currently responsible for all manufacturing and quality operations at the King of Prussia, Pennsylvania facility. Mr. Lowry joined Immune Response in June 1995, and has over 15 years experience in biopharmaceutical research, bioprocess development, and large scale GMP manufacturing.
The 52,500 square foot plant can be scaled up to meet demand for commercialization. This plant has been certified as compliant with the FDA’s Good Manufacturing Practices (GMP) and meets Biosafety Level III standards.
Manufacturing capacity is currently about one million doses of product per year, making it the largest plant of its kind. The company is refining the manufacturing process, and recently reported on process improvement that increase yield by 2-fold. Additional development could lead to capacity of between 2 to 4 million doses per year.
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ABOUT THE IMMUNE RESPONSE CORPORATION The Immune Response Corporation (OTCBB: IMNR) is an immuno-pharmaceutical company focused on developing products to treat autoimmune and infectious diseases. Their lead immune-based therapeutic product candidates are NeuroVax™ for the treatment of multiple sclerosis (MS) and IR103 for the treatment of Human Immunodeficiency Virus (HIV). Both of these therapies are in Phase II clinical development and are designed to stimulate pathogen-specific immune responses aimed at slowing or halting the rate of disease progression. NeuroVax™, which is based IMNR’s patented T-cell receptor (TCR) peptide technology, has shown potential clinical value in the treatment of relapsing forms of MS. NeuroVax™ has been shown to stimulate strong disease specific cell mediated immunity in nearly all patients treated by enhancing levels of FOXP3+ T Regulatory (Treg) cells that are able to down regulate the activity of pathogenic T-cells that cause MS. Increasing scientific findings have associated diminished levels of FOXP3+ Treg cell responses with the pathogenesis and progression of MS and other autoimmune diseases such as rheumatoid arthritis (RA), psoriasis and Crohn’s disease.
In addition to MS, IMNR has opened Investigational New Drug Applications (IND) with the U.S. Food and Drug Administration (FDA) for clinical evaluation of TCR peptide-based immune-based therapies for RA and psoriasis. IR103 is based on their patented whole-inactivated virus technology, co-invented by Dr. Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE® , our first-generation HIV product candidate. IR103 is a more potent formulation that combines its whole-inactivated antigen with a synthetic Toll-like receptor (TLR-9) agonist to create enhanced HIV-specific immune responses. IMNR is currently testing IR103 in two Phase II clinical studies as a first-line treatment for drug-naïve HIV-infected individuals not yet eligible for antiretroviral therapy according to current medical guidelines. In early 2006 IMNR made a strategic decision to accelerate the development of IR103, rather than pursue a Phase III trial with REMUNE® . All of IMNR products are still in the development stage. IMNR has never had revenues from the sale of products. IMNR was founded in 1986.
Forward Looking Statement: This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. While these statements are meant to convey to the public the company’s progress, business opportunities and growth prospects, readers are cautioned that such forward-looking statements represent management’s opinion. While management believes such representation to be true and accurate based on the information available to the company, actual results may differ materially from those described. The company’s operations and business prospects are always subject to risks and uncertainties. Important facts that may cause actual results to differ are set forth in IMNR’s periodic filings with the U.S. Securities and Exchange Commission.
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Sources:
ROI Group Associates (contact for further information)
39 Broadway; NY, NY 10006
212.495.0744
abrown@roiny.com
IMNR — Immune Response Corp. (The)
5931 Darwin Court
Carlsbad, CA 92008
Website: http://www.imnr.com
Phone: 760-431-7080
