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R-Biopharm, Apogenix to Develop CDx for Cancer Drug

NEW YORK (GenomeWeb) – German firms R-Biopharm and Apogenix today announced a companion diagnostic development deal for Apogenix's novel lead drug candidate APG101. 

The partners will develop a companion diagnostic test for the drug, a CD95 ligand inhibitor, based on immunohistochemistry and PCR technologies in order to stratify patients and identify glioblastoma patients most likely to respond to APG101. They said that R-Biopharm will run several CDx development programs in parallel, and the tests will be used and validated by Apogenix in a pivotal clinical trial in glioblastoma, as well as clinical trials for the treatment of other solid tumors.                                                            

Financial and other terms of the agreement were not disclosed. 

APG101 works by restoring the body's immune response against tumors and inhibiting invasive tumor cell growth. It is being developed as a treatment for solid tumors and malignant hematological diseases. According to the partners, data from a randomized, controlled phase II efficacy trial in patients with recurrent glioblastoma demonstrated the superiority of the drug in combination with radiotherapy in all study endpoints, compared to treatment with radiotherapy alone. 

"These diagnostic tests will allow us to develop APG101 as a targeted therapy for the treatment of cancer, so patients can benefit from a personalized treatment approach," Apogenix CMO Harald Fricke said in a statement. "Since the CD95 ligand is expressed in many types of cancer, there is tremendous potential for the use of APG101."