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GSK, OncoMethylome Investigating Methylation Markers in Immunotherapy Program

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Originally published Sept. 28.

By Turna Ray

In its third drug/diagnostic co-development deal announced in 14 months, GlaxoSmithKline has struck a partnership with OncoMethylome Sciences for the "potential use" of one of OncoMethylome's DNA methylation-specific PCR biomarkers to personalize a drug in its immunotherapy development program.

OncoMethylome could not disclose to PGx Reporter the specific drug development program in which its marker will be used. "GSK has several immunotherapy projects, and at this stage we are not allowed to disclose the program we are working on," OncoMethylome CEO Jan Groen said in an e-mail.

In a statement announcing the deal last week, OncoMethylome described the biomarker of interest as "stable, highly accurate, and, unlike many other biomarkers, [it] allows for the analysis of non-invasive tissue samples."

GSK's undisclosed immunotherapeutic will be co-developed with OncoMethylome's test, according to Groen.

It can be surmised however, that OncoMethylome's biomarker will mostly likely be used to personalize a drug in GSK's internal Adjuvants program, which is focused on developing adjuvant therapies for diseases with limited treatment options, such as cancer. As part of this program, GSK is advancing a class of drugs called Antigen-Specific Cancer Immunotherapeutics, or ASCIs, in the oncology setting.

GSK's latest pipeline, last updated in February, includes three ASCIs under development: a MAGE-A3 antigen in non-small cell lung cancer and melanoma in Phase III studies; and a WT1 ASCI in acute myeloid leukemia in Phase II trials.

The two MAGE-A3 indications are already spoken for in terms of companion diagnostic development.

In July 2009, GSK inked a deal with Abbott Molecular to develop a PCR-based commercial pharmacogenomic test for its investigational non-small cell lung cancer immunotherapeutic. The companion test will be based on Abbott's m2000 instrument platform and will screen NSCLC tumors for expression of the MAGE-A3 antigen in order to determine which patients should receive GSK's MAGE-A3 ASCI (PGx Reporter 07/15/09).

This year, GSK and Abbott extended their prior collaboration into developing a commercial test for the MAGE-A3-targeting ASCI for the adjuvant treatment of skin cancer (PGx Reporter 03/10/10).

That leaves the WT1 ASCI, an immunotherapy targeting the so called Wilms' tumor suppressor gene, which encodes the zinc-finger protein WT1 that has been shown to inhibit cell growth in certain cancers. According to previously published data, the WT1 gene is expressed in 73 percent to 100 percent of patients with AML and is thought to keep leukemia cells viable.

According to ClinicalTrials.gov, GSK is currently recruiting participants for a Phase I study involving the WT1 ASCI, investigating the safety of the drug when given as a post-consolidation treatment in patients with WT1-positive AML in first complete remission. The inclusion criteria for the trial require that patients' blast cells show expression of WT1 transcript, detected by quantitative real-time PCR.

GSK is also studying the drug in a Phase I trial as a treatment for AML patients with a suboptimal clinical response to induction chemotherapy. This study has similar inclusion criteria.

In addition to its partnership with GSK, OncoMethylome has several other collaborations with cancer research centers, such as Johns Hopkins, as well as commercial and collaborative partnerships with Laboratory Corporation of America, Schering-Plough, Roche, Merck Serono, and Qiagen.

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