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www.fdanews.com/articles/172334-apogenix-r-biopharm-collaborate-on-companion-diagnostics-for-apg101
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Apogenix, R-Biopharm Collaborate on Companion Diagnostics for APG101

July 28, 2015

Apogenix has entered into an agreement with fellow German medical firm R-Biopharm to develop companion diagnostic tests for Apogenix’s drug candidate APG101, a CD95 ligand inhibitor immuno-oncology treatment.

To develop the tests, the companies will rely on immunohistochemistry and polymerase chain reaction technologies, with the devicemakers also designing in vitro diagnostics to determine the presence of certain types of tumors, including CD95 ligand expressions.

In a phase 2 study, patient with recurrent glioblastoma treated with APG101 in combination with radiotherapy had better outcomes than those treated with radiotherapy alone, Apogenix says. The patient arm dosed with the drug had a median overall survival of 16.1 months, compared to 7.3 months in the control arm.

Apogenix will conduct further efficacy trials, involving the diagnostic tests, in pivotal phase 2/3 trials for glioblastoma patients, as well as conducting additional studies for other solid tumor treatments. — Jason Scott