Abbott expands companion Dx agreement with GSK to add test for additional investigational cancer immunotherapy antig

The existing agreements between Abbott and GlaxoSmithKline Biologicals S.A., announced in July2009 and March 2010, focused on the development of polymerase chainreaction (PCR) tests to screen non-small cell lung cancer and melanomatumors for expression of the MAGE-A3 antigen. Under the expandedagreement, Abbott will develop a PCR test for use on the Abbott m2000rt instrumentto screen non-small cell lung cancer tumors for the expression of thePRAME antigen. PRAME is a preferentially expressed antigen of melanomathat is expressed in 69 percent of non-small cell lung cancer cases, aswell as in a wide variety of cancer types, including melanoma, breast,ovarian, and bladder cancer, with limited expression in normal cells.

Abbott's sees its development efforts in areas such as MAGE-A3 and PRAME as being among they keys to further building its leadership position in cancer diagnostics andpersonalized medicine.

"This expanded collaboration, along with Abbott's other recentlyannounced partnerships in oncology, demonstrates the continuedcommitment Abbott is making to assess biomarkers linked toimmunotherapies in various cancers," said Stafford O'Kelly, head ofAbbott's molecular diagnostics business. "This agreement is a testamentto the scientific advances Abbott and the industry is making inpersonalized medicine and companion diagnostics, which are helpingensure the right medicines get to the right cancer patients."

GSK's antigen-specific cancer immunotherapy (ASCI) program is focused on a novel class of medicines designed to trainthe immune system to recognize and eliminate cancer cells in a highlyspecific manner. These novel cancer immunotherapeutics combine tumorantigens, delivered as purified recombinant proteins, and GSK'sproprietary Adjuvant Systems, which are specific combinations ofimmunostimulating compounds selected to increase the anti-tumor immuneresponse.

As GSK and Abbott note, ASCIs are being investigated in the clinic to support theiruse to reduce the risk of tumor recurrence following surgery, or toimpact tumor growth in an early metastatic setting. The highly specificmode of action of GSK's ASCIs is said to allow development of diagnostic tools toaid in selecting patients eligible for the treatment, depending on theexpression of the tumor antigens.

MAGE-A3 is a tumor-specific antigen that is expressed in a largevariety of cancers, including melanoma, non-small cell lung, head andneck, and bladder cancer, with no expression in normal cells. Expressionof the MAGE-A3 gene has been observed in testicular cells but withoutantigen presentation capabilities. MAGE-A3 protein has been in-licensedby GSK from the Ludwig Institute for Cancer Research, reportedly the largestinternational academic institute dedicated to understanding andcontrolling cancer.

SOURCE: GSK/Abbott news release