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Siemens Forges CDx Deals for HIV, Brain Cancer Drugs

NEW YORK (GenomeWeb News) – Siemens Healthcare Diagnostics today announced two deals to develop companion diagnostics for candidate drugs currently in clinical trials.

One deal with ViiV Healthcare focuses on ViiV's Celsentri/Selzentry (maraviroc) AIDS therapy. The other with Tocagen is targeted at that firm's gene therapy for treating primary brain cancer.

Financial details were not disclosed for either deal.

As part of its agreement with UK-based ViiV, which was formed by GlaxoSmithKline and Pfizer in 2009 to focus on HIV medications, Siemens said that it will develop a diagnostic to evaluate the most appropriate patients for the pharma firm's novel CCR5 co-receptor antagonist for treating CCR5-tropic HIV. Siemens would also commercialize its test, dependent on approval by the US Food and Drug Administration.

In October ViiV started its Phase III trial for Celsentri/Selzentry. Called MODERN, or Maraviroc Once daily with Darunavir Enhanced by Ritonavir in a Novel regimen, the trial compares Celsentri/Selzentry with Truvada (emtricitabine/tenofovir), both in combination with darunavir/ritonavir.

The 96-week trial will assess a two-drug regimen against a three-drug regimen for treating antiretroviral-naïve patients infected with CCR5-tropic HIV-1.

MODERN is the first large-scale trial that compares a genotypic test with a phenotypic test for identifying patients who may benefit from Celsentri/Selzentry, Siemens said. It will provide genotypic testing in the trial, while LabCorp subsidiary Monogram Biosciences is providing phenotyping testing.

Its deal with San Diego-based Tocagen gives Siemens commercialization rights to diagnostic tests for monitoring the levels of viral gene therapy Toca 511 (vocimagene amiretrorepvec) and Toca FC (flucytosine).

Tova 511 an injectible and Toca FC is an extended-release tablet. Tova 511 is a retroviral replicating vector for delivering a cytosine deaminase gene selectively to cancer cells. After Toca 511 spreads through a tumor, the cancer cells expressing the cytosine deaminase gene may convert the antibiotic flucytosine into the anti-cancer drug 5-fluorouracil, Siemens said.

Tocagen is enrolling patients for its clinical trials and will partner with Siemens on assays used for the trials.

Siemens recently announced a sequencing partnership with Illumina targeting HIV, and in a statement today said that its companion diagnostic business complements that move. It further plans to partner with drug firms to offer clinical trial expertise, and diagnostic test development and commercialization.

"Siemens’ presence in the emerging companion diagnostics market enables us to leverage our innovation capabilities and deep clinical knowledge to help improve pharmaceutical drug safety and effectiveness," Michael Reitermann, CEO of Siemens Healthcare Diagnostics, said. "More so, it helps align Siemens with new classes of therapies tailored to the individual that hold the promise of improving patient care and delivering on the goal of personalized medicine."