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OncoMethylome Inks Companion Dx Deals, Reports 17 Percent Revenue Drop in H1 2009


By Turna Ray

Halfway into the year, OncoMethylome Sciences has made progress in its goal of expanding existing and securing new drug/diagnostic collaborations, but the company has also incurred greater net losses as a result of increased spending on ongoing clinical trials.

In reporting its half-year 2009 financial results last month, OncoMethylome Sciences announced it has inked new partnerships with pharmaceutical companies to discover cancer biomarkers for companion diagnostic development, and is providing companion diagnostic testing services for two clinical trials on personalizing glioblastoma treatments.

For the six months ended June 30, OncoMethylome's revenues fell 17 percent due to one-time up-front fees and milestone payments in 2008 that were not repeated in 2009. The Liege, Belgium-based molecular diagnostics firm reported revenues of €1.3 million ($1.9 million) for the first six months of 2009, compared to revenues of €1.5 million for the first half of 2008.

"OncoMethylome's current revenues are highly dependent on fees from certain new deals and milestones, for which the exact timing is uncertain," the company said in a statement. Previously, the company had said that 2009 revenues would increase due to tests currently sold in North America, new commercial deals, and expansion of personalized medicine partnerships.

The company announced in April that it had inked a deal with the US-based Radiotherapy Oncology Group to provide MGMT gene promoter methylation testing in a Phase III clinical trial in glioblastoma patients comparing the standard-of-care, concurrent chemoradiation and adjuvant treatment with Schering-Plough's Temodar, versus chemoradiation and adjuvant therapy with Genentech's Avastin.

In March, OncoMethylome said it was providing MGMT gene promoter methylation testing for Merck KGaA's investigational oncologic, cilengitide, which is in Phase II clinical trials as a treatment for glioblastoma patients.

According to the company, it is currently involved in several collaborations using its methylation technology with academic and industry partners, including Johns Hopkins University, Johnson & Johnson subsidiary Veridex, the Laboratory Corporation of American, Schering-Plough, GlaxoSmithKline Biologicals, Abbott, Millipore's BioScience division, EXACT Sciences, and Qiagen.

OncoMethylome's methylation technology-based products are based on technology invented by Johns Hopkins. The company did not name the new pharma partners for which it was conducting companion diagnostic biomarker research.

During the first half of the year, the company also made improvements to a blood-based colorectal cancer screening test it is in the process of developing. According to a statement from OncoMethylome, during the first six months, the company completed a 2,000 patient trial using the colorectal cancer assay, which further validated the test, and initiated a new 5,000-patient trial.

Regarding this test, OncoMethylome is following up with "various potential distribution partners."

"Most of the R&D efforts in H1 2009 were focused on enhancing the ease of use of the blood-based colorectal cancer screening test for commercial purposes and validating the test on ever-increasing clinical sample sets," Herman Spolders, CEO of OncoMethylome, said in a statement.

During the past six months, OncoMethylome's R&D expenses declined to €5.6 million ($8 million) from €5.8 million ($8.3 million) year over year, while its SG&A spending increased to €2.1 million ($3 million) from €1.8 million ($2.5 million).

Also in this period, OncoMethylome presented clinical data on a urine sample-based bladder cancer assay that showed the test had 90 percent sensitivity and 93 percent specificity.

For the full year 2009, the company plans to increase its spending on ongoing clinical trials and said it expects its loss in 2009 to be higher than the €10.2 million ($14.6 million) loss it reported the previous year.

For the first six months of 2009, the company reported a net loss of €6.3 million ($9 million) versus a net loss of €5.7 million ($8.2 million) for the first half of 2008.

OncoMethylome said it had cash and cash equivalents of €23.7 million ($34 million) as of June 30.