The Immune Response Corporation
(OTCBB: IMNR)
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The Immune Response Corporation
The Immune Response Corporation (OTCBB: IMNR) is a development stage biotechnology company with two products in Phase II clinical trials, one that targets multiple sclerosis (MS) and another that targets HIV/AIDS. These drugs act by stimulating the body’s immune system to slow or stop disease progression through mechanisms of action that differ from existing drugs. These diseases have large patient populations and substantial room for improvement over current therapies. If successful, these drugs could be used alone or in combination with other drugs, giving multi-billion dollar sales potential. The Company has made significant changes over the past year, including advancing new clinical-stage products and a new CEO.
Company Highlights
* The Company’s product pipeline includes two clinical stage therapeutics. NeuroVax is in Phase II development for multiple sclerosis, and IR103 is in Phase II for treatment of HIV infection. These products may be used as single therapies and have the potential to be additive or synergistic with other drugs in controlling these diseases.
* NeuroVax, the Company’s therapy for Multiple Sclerosis, is aimed at controlling immune system cells that attack the patients’ tissues and cause autoimmune disease. MS is a disease in which the patient’s immune system reacts against its own nerve cells, eventually destroying the insulating myelin coat that surrounds the nerve. Regulating the disease-causing cells of the immune system could prevent the tissue destruction characteristic of MS and other autoimmune diseases.
* Other applications of the immune-based therapeutic vaccine products under investigation include other autoimmune diseases, such as psoriasis and rheumatoid arthritis. The company has filed Investigational New Drug (IND) applications that could allow it to accelerate clinical trials rapidly.
* The Company’s HIV/AIDS products are based on its patented whole-inactivated viral antigen technology developed by Company founder Dr. Jonas Salk. The mechanism of action is to replenish and stimulate the patient’s immune system to fight the infection. IR103 is a more potent, second generation product. This product is being developed to enhance the immune system’s ability to fight the HIV virus and extend the time before anti-reteroviral therapies are needed.
Founded by a Medical Legend
The Immune Response Corporation was founded in 1986 by Dr. Jonas Salk, developer of the first polio vaccine. The Company’s therapies in development are based on using the immune system to treat diseases, including HIV/AIDS, multiple sclerosis, and other autoimmune diseases. Successful commercialization of discoveries championed by Immune Response would be a groundbreaking advance in the treatment of these diseases.
The Company’s approach to HIV uses a whole inactivated virus antigen. This contrasts to vaccines based on a viral surface marker or subunit vaccines (made of linear peptide sequence from the antigen), which were tested by numerous companies in the mid 1990s to early 2000s with no success.
The original HIV technology was co-developed by Dr. Jonas Salk and scientists affiliated with the Company. Dr. Salk was a member of Immune Response’s Board of Directors and a scientific advisor until his death in 1995. His son, Dr. Peter Salk, currently the Vice President and Scientific Director of the Jonas Salk Foundation, is a member of Immune Response Corporation’s HIV/AIDS Scientific Advisory Board.
New CEO
On November 1, 2005, a new CEO joined the Company, bringing extensive experience in HIV/AIDS and public health policy and managaing complex organizations. Joseph F. O’Neill, M.D., M.S., M.P.H., has spent the past five years in AIDS-related health policy management and administration. He joined the Company after serving 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). His responsibility was to carry out policy and oversee the financial disbursements to over 100 countries, with $2.4 billion disbursed in the first year alone. He also managed a staff of over 200 located around the world.
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 also served as Director of the HIV/AIDS Bureau of the Health Resources and Services Administration, responsible for management of the $1.9 billion Ryan White CARE program, the nation’s largest health care program serving people living with AIDS.
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.
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. 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 curently about one million doses of product per year, making it one of 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. This is one of the few facilities in the world that can produce large quantities of live HIV vaccines.
NeuroVax is currently produced partially by contract manufacturers, with the finishing steps completed by Immune Response. The Company can scale up capacity for NeuroVax manufacturing at the King of Prussia plant when necessary.
Basic Background On The Immune System
In order to understand The Immune Response Corporation’s products, a brief background of the immune system is presented below.
The immune system has several different types of cells which work together to protect the individual. The two major types of cells are B-cells—which produce antibodies— and T-cells, which provide a cellular-based immunity. The relevant T-cell types are:
* T-helper cells, or CD4+ cells, named after a protein marker on their surface. These cells find the foreign substances to be destroyed and “help” by attracting other immune cells.
* T-killer cells, also known as CD8+ cells or CTLs (cytotoxic lymphocytes), are cells that kill infected cells or pathogenic organisms to protect the individual.
* T-regulatory cells control the other cells, activating or suppressing them as needed.
Vaccines
Conventional vaccines are designed to prevent infections. These vaccines typically contain an antigen that is a killed or weakened (attenuated) form of a bacteria or virus (or other pathogenic substance), while newer recombinant vaccines only use an antigenic portion of the pathogen. In this way, the vaccine “teaches” the immune system to recognize foreign substances and prevent disease.
Immune Response Vaccines
The Immune Response vaccines differ from the conventional vaccines in that they are intended to stimulate a T-cell response with immune system cells that fight the antigen rather than an antibody response from the B-cells. The Company’s products also differ in that they are therapeutic vaccines designed to fight an existing disease rather than to prevent a future one.
Upon administration, the immune system will recognize the vaccine’s antigen and start a primary immune response. The B-cell portion of this response begins producing antibodies, which can be detected in the bloodstream after several days. The antibody levels will peak in a few days, then decline. This forms a population of “memory cells” which can then be activated upon future contact with the specific antigen.
Upon second exposure to the antigen, the antibody levels in the bloodstream rise more rapidly and more abundantly than the primary response. This allows for quick protection against a second infection. This is known as a “humoral” or antibody response.
Market Risks
The Immune Response Corporation is a biotechnology company with drugs in early and middle stages of clinical development. There can be no certainty that the drugs in development will be successful in clinical trials or the marketplace.
Drug development is a highly regulated industry, with risks relating to product approval. The Company may experience delays of unpredictable lengths in meeting clinical milestones. Product sales can be affected by changes in federal reimbursement policies that are subject to change each year. The drugs may not reach the expected levels of clinical acceptance or profitability. They may not win approval of reimbursement by third party payers.
As with all biotechnology companies, products in development carry a risk of clinical trial failure, technology failure, and manufacturing failure. Even drugs that successfully overcome these hurdles may compete for markets that are smaller than initially anticipated as a result of obsolescence or dominance by competitors.
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