Abbott has entered into an agreement with GlaxoSmithKline (GSK) to develop an automated molecular diagnostic test, based on polymerase chain reaction (PCR) technology, intended to screen non-small cell lung cancer (NSCLC) tumors for expression of the MAGE-A3 antigen. GSK's MAGE-A3 ASCI (Antigen Specific Cancer Immunotherapy) candidate is currently being evaluated as an adjuvant treatment in resected NSCLC in the Phase III clinical study MAGRIT, the largest lung cancer treatment study ever conducted. To be eligible to receive GSK's MAGE A3 ASCI, patients must have MAGE-A3 expressing NSCLC tumors. MAGE-A3 is a tumor-specific antigen that is expressed in non-small cell lung cancer and a wide variety of other cancers, but not in normal cells.
Under terms of the agreement, Abbott, in conjunction with GSK, will develop and commercialize a PCR test designed to detect MAGE A3 for use on the Abbott m2000(TM) automated instrument system.
"This is an exciting collaboration with a leading company in cancer immunotherapy research," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "The agreement is indicative of our focus on personalized medicine and developing analytical molecular tools to identify patients most likely to benefit from important pharmacogenomic therapies."
Currently, there are no nucleic acid based tests approved by the U.S. Food and Drug Administration for use in identifying patients who may derive treatment benefits from targeted non-small cell lung cancer therapies.
"Lung cancer is the biggest cancer killer globally," said Vincent Brichard, M.D., Ph.D., vice president and head of Immunotherapeutics, GSK. "Through this partnership we aim to make MAGE-A3 testing of lung tumors available in standard pathology labs around the world. This means patients globally could be able to find out if they are eligible and can potentially benefit from targeted cancer treatment against this antigen, such as GSK's MAGE-A3 candidate ASCI."
ASCIs and MAGE-A3 ASCI
GSK's ASCIs represent a novel class of medicines designed to train the immune system to recognize and eliminate cancer cells in a highly specific manner. These novel cancer immunotherapeutics combine tumor antigens, delivered as purified recombinant proteins, and GSK's proprietary Adjuvant Systems, which are specific combinations of immunostimulating compounds selected to increase the anti-tumor immune response. ASCIs are being investigated in the clinic to support their use to reduce the risk of tumor recurrence following surgery, or to impact tumor growth in an early metastatic setting. The highly specific mode of action of GSK's ASCIs allows development
of diagnostic tools to aid in selecting patients eligible for the treatment, depending on the expression of the tumor antigens.
MAGE-A3 is a tumor-specific antigen that is expressed in a large variety of cancers, including melanoma, non-small cell lung cancer, head and neck cancer, bladder cancer, with no expression in normal cells. Expression of the MAGE-A3 gene has been observed in testicular cells but without antigen presentation capabilities. MAGE-A3 protein has been in-licensed by GSK from the Ludwig Institute for Cancer Research, the largest international academic institute dedicated to understanding and controlling cancer. MAGE-A3 ASCI is an investigational compound and it is not approved for use in any indication in any country at this time.
Websites have been created to provide information on the ASCI approach and the MAGRIT clinical study. Please visit www.immunotherapyforcancer.com and www.gsk-asci.com for more information.
Molecular Tests for Oncology
Abbott's development efforts in areas such as MAGE-A3 will further build its leadership position in cancer diagnostics and personalized medicine.Abbott is a pioneer in the use of molecular tests based on PCR and fluorescence in situ hybridization (FISH) technologies to aid clinicians in the selection of appropriate pharmacogenomic therapies. Abbott's FISH products deliver unsurpassed sensitivity for early diagnosis and monitoring of cancer and the ability to identify patients who can benefit from appropriate therapies, improving outcomes and extending patient survival.
The m2000 System
The Abbott m2000 system is an automated instrument for DNA and RNA testing in molecular laboratories. The m2000 system is based on real-time PCR technology and consists of the m2000sp for automated sample preparation and the m2000rt for PCR detection an analysis, offering an efficient workflow for the lab.
The Abbott m2000 instrument is marketed in most major markets throughout the world and offers an extensive menu for infectious disease testing, including HIV viral load, hepatitis B viral load, chlamydia detection, chlamydia/gonorrhea (CT/NG) multiplexed assay, hepatitis C (HCV) viral load, HCV genotyping, cytomegalovirus, Epstein-Barr virus and human papillomavirus.
With the exception of the CT/NG assay, these tests currently are not available on the m2000 in the United States.
About Abbott Molecular
Abbott's molecular diagnostics business, headquartered in Des Plaines, Ill., provides physicians with critical information based on the early detection of pathogens and subtle changes in patients' genes and chromosomes, allowing for earlier diagnosis, selection of appropriate therapies and monitoring of disease progression.The business includes instruments and reagents used to conduct sophisticated analysis of patient DNA and RNA.
Additional information is available on Abbott Molecular's Web site at www.abbottmolecular.com.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com.