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The Immune Response Corporation Announces Initial HIV-1 Viral Antigen Yields Improved at Least Two-Fold Through New Manufacturing Process
Tuesday June 27, 9:00 am ET
Medium Optimization Process Presented This Week at the Vaccine Technology Conference
CARLSBAD, Calif.--(BUSINESS WIRE)--June 27, 2006--The Immune Response Corporation (OTCBB:IMNR - News) announced today the development of a serum-free, chemically defined cell culture medium for the production of HIV-1 from HUT-78 cells, a human T-cell lymphoma cell line. A poster on the medium optimization process is being presented this week at the Vaccine Technology conference in Puerto Vallarta, Mexico. This conference is being held June 25th-30th, and is a biopharmaceutical development and manufacturing event with a special emphasis on HIV vaccine candidates and other global vaccines. The development of this medium is an important step in the development of a vaccine utilizing whole-inactivated HIV to stimulate the human immune system against the virus. The Immune Response Corporation is currently evaluating this approach for a therapeutic vaccine in clinical trials of its second-generation HIV immunotherapy IR103. This technology will also be utilized toward the development of a preventive vaccine candidate.
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The purpose of a therapeutic vaccine for HIV is to bolster the immune system to more effectively mount a sustained attack against HIV-infected cells. This may be accomplished by allowing the body to create and maintain a memory of the core proteins making up the virus by exposing it to an inactivated form of HIV that could not infect or destroy the immune cells. In order to create this vaccine candidate, cells chronically infected with the virus require growth and expansion in large quantities. The resulting whole virus contained in the clarified production medium is then inactivated and further purified through a scientifically robust and strictly regulated process.
The Company has collaborated with Irvine Scientific, a leading medical device/biotechnology company located in Santa Ana, CA, to develop a chemically defined, serum-free cell culture medium for the production process that eliminates all animal-derived components, improves viral yield, and is designed to provide consistently high cell growth through to full-scale production, while maintaining the performance of the final vaccine product as an immunological stimulant against HIV.
"The progress reported at this conference represents a significant advance for the Company," said Peter Lowry, Vice President of Manufacturing Operations at The Immune Response Corporation. "This new serum-free medium greatly enhances our ongoing efforts toward an efficient, economically viable, and reproducible manufacturing process that will allow us to produce safe and consistent whole-inactivated viral vaccines in large quantities."
Through a process of screening and optimization, the Company demonstrated that the human T-cell lymphoma cell line HUT-78 (chronically infected with HIV-1) can be grown and reliably passaged in a chemically-defined cell culture medium, with cell densities exceeding two million cells/ml. In addition, initial HIV-1 viral antigen yields were improved at least two-fold over the serum supplemented medium originally used.
The Company believes that, in parallel with the continuation of the IR103 Phase II clinical program, this new medium represents a valuable step in the development of an economically sound and transferable manufacturing process for the vaccine in the future.
About IR103
More than 25 million people have died since human immunodeficiency virus (HIV) was first recognized in 1981 (source: UNAIDS, December 2005), and the new infection rate continues to grow at an alarming rate. Despite medical advances, the worldwide pandemic continues to claim more than 3.1 million lives each year (source: UNAIDS, December 2005). Additional safe and effective treatments are desperately needed for the estimated 40 million adults and children living with HIV as of 2005.
IR103 is a second-generation HIV immunotherapy based on the Company\'s patented, whole-inactivated virus technology, which was co-invented by Dr. Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE®, the Company\'s first-generation HIV product candidate. Preclinical research and recent clinical data show that 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. This product differs from currently available antiretroviral drug therapies since it is designed to stimulate an HIV-infected individual\'s immune system to fight the virus.
About The Immune Response Corporation
The Immune Response Corporation (OTCBB:IMNR - News) is an immuno-pharmaceutical Company focused on developing products to treat autoimmune and infectious diseases. The Company\'s lead immune-based therapeutic product candidates are NeuroVax(TM) for the treatment of multiple sclerosis (MS) and IR103 for the treatment of HIV infection. 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(TM), which is based on the Company\'s patented T-cell receptor (TCR) peptide technology, has shown potential clinical value in the treatment of relapsing forms of multiple sclerosis (MS). NeuroVax(TM) has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all patients treated and appears to work by enhancing levels of FOXP3+ 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, the Company has open Investigational New Drug Applications (IND) with the FDA for clinical evaluation of TCR peptide-based immune-based therapies for RA and psoriasis.
IR103 is based on the Company\'s patented, whole-inactivated virus technology, co-invented by Dr. Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE®, the Company\'s 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. The Company is currently testing IR103 in two Phase II clinical studies as a first-line treatment for drug-naive HIV-infected individuals not yet eligible for antiretroviral therapy according to current medical guidelines.
NeuroVax(TM) and IR103 are in clinical development by The Immune Response Corporation and are not approved by any regulatory agencies in any country at this time. Please visit The Immune Response Corporation at www.imnr.com.
This news release contains forward-looking statements. Forward-looking statements are often signaled by forms of words such as should, could, will, might, plan, projection, forecast, expect, guidance, potential and developing. Actual results could vary materially from those expected due to a variety of risk factors, including whether the Company will continue as a going concern and successfully raise proceeds from financing activities sufficient to fund operations and additional clinical trials of NeuroVax(TM) or IR103, the uncertainty of successful completion of any such clinical trials, the fact that the Company has not succeeded in commercializing any drug, the risk that NeuroVax(TM) or IR103 might not prove to be effective as either a therapeutic or preventive vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of NeuroVax(TM) or IR103 in preclinical trials and/or earlier clinical trials. A more extensive set of risks is set forth in The Immune Response Corporation\'s SEC filings including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2005, and its subsequent Quarterly Reports filed on Form 10-Q. The Company undertakes no obligation to update the results of these forward-looking statements to reflect events or circumstances after today or to reflect the occurrence of unanticipated events.
REMUNE® is a registered trademark of The Immune Response Corporation. NeuroVax(TM) is a trademark of The Immune Response Corporation.
Contact:
The Immune Response Corporation
Michael K. Green, 760-431-7080
info@imnr.com
or
Media Contact:
Chamberlain Communications Group Inc.
David Kyne, 212-884-0661
dkyne@chamberlainpr.com
or
Investor Contact:
ROI Associates
Robert Giordano, 212-495-0201
rgiordano@roiny.com
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Source: The Immune Response Corporation
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