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The Immune Response Corporation has issued an end of year report.
The Immune Response Corporation’s product pipeline has two clinical stage therapeutics in phase 2 development, NeuroVax for multiple sclerosis (MS), and IR103 for HIV/AIDS. The report was issued by Spelman Research’s Stelian Mitu, an experienced investment research analyst, who received his CFA charter in 2003 and MBA degree in 1997.
In the Spelman report, Mitu writes, “The drug candidates, IR103 (HIV) and NeuroVax (MS), are based on innovative technologies that do not have analogues on the market…. If successful, IMNR’s drugs may offer significant advantages over their competitors.”
The Immune Response Corporation (IMNR) 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 for the treatment of MS and IR103 for the treatment of HIV infection. Both of these therapies are in phase 2 clinical development and are designed to stimulate disease pathogen-specific immune responses aimed at slowing or halting the rate of disease progression.
NeuroVax, which is based on the company’s patented T-cell receptor (TCR) peptide vaccine 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 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 disease.
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 2 clinical studies as a first-line treatment for drug-naive HIV-infected individuals not yet eligible for antiretroviral therapy according to current medical guidelines.
Report 2: The Immune Response Corporation (IMNR), an immuno-pharmaceutical company developing products to treat autoimmune and infectious diseases, announced it has raised $9.9 million in gross proceeds from investors exercising 495,552,100 warrants from the first tranche warrants that were issued in the company’s March 2006 private placement financing.
The total gross proceeds include an investment of $250,000 by Qubit, LLC, an affiliate of the company’s largest stockholder and director, Kevin Kimberlin, to exercise 12,500,000 warrants that were issued in conjunction with a February 2006 transaction related to the March 2006 financing.
In the March financing, the company issued $8 million of secured notes convertible into 400,000,000 shares of common stock at 2 cents per share, accruing interest at 8% per year and maturing on January 1, 2008.
Report 3: The Immune Response Corporation (IMNR) announced 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.
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.
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 medical device and biotechnology company located in Santa Ana, California, 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.
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 Immune Response Corporation 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 for the treatment of multiple sclerosis (MS) and IR103 for the treatment of HIV infection.
If you missed it:
Dr. Joseph O’Neill, President and CEO of the Immune Response Corporation , will present an overview of the Company’s immune-based therapies, currently in Phase II clinical trials, at the Wall Street Analyst Forum Biotechnology & Healthcare Conference (WSAF) in New York City.
The Company’s presentation to the WSAF will take place on Thursday, December 7, 2006, at 11:10 am (EST). A live webcast of this presentation is available at http://www.investorcalendar.com/CEPage.asp?ID=111522%20. The online replay will be available for 30 days after the presentation.
For further information contact:
ROI Group Associates
39 Broadway; NY, NY 10006
212.495.0744
MDodge@roiny.com
Source:
IMNR — Immune Response Corp. (The)
5931 Darwin Court
Carlsbad, CA 92008
Website: http://www.imnr.com
Phone: 760-431-7080
Forward Looking Statement and Safe Harbor: Any information regarding The Immune Response Corporation (”IMNR”) in this communication is neither an offer nor solicitation to buy or sell any securities mentioned. While we believe all sources of information to be factual and reliable, in no way do we represent or guarantee the accuracy thereof, nor the statements made herein. THE READER SHOULD VERIFY ALL CLAIMS AND DO ITS OWN DUE DILIGENCE BEFORE INVESTING IN ANY SECURITIES MENTIONED. ROI Group Associates, Inc. (”ROI”) is the investor relations counsel for IMNR and accepts compensation from the IMNR for this effort, including a monthly cash retainer and restricted stock. Under the terms of its investor relations Service Agreement, ROI has agreed not to sell any of the IMNR restricted stock received as compensation under the Service Agreement during the entire term of its engagement as IMNR’s investor relations counsel pursuant to this Service Agreement. ROI shall be under no obligation to update readers about any restrictions on its trading activities regarding IMNR.
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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