R-Biopharm will develop a companion diagnostic for Apogenix's lead anticancer candidate under an agreement the two just signed.
Germany's Apogenix says glioblastoma patients with a certain biomarker associated with the CD95 ligand fared best when treated in combination with radiotherapy during its Phase II efficacy trial. They experienced a median overall survival of 16.1 months versus 7.3 months among patients treated with radiotherapy alone.
According to a release, the diagnostic will include different paradigms, including immunohistochemistry and polymerase chain reaction to determine which patients are most likely to benefit from the candidate. Apogenix said will it develop the in vitro diagnostic for expression of the CD95 ligand in its pivotal Phase II/III for glioblastoma, and other trials for the treatment of other solid tumors.
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| Apogenix Chief Medical Officer Dr. Harald Fricke |
"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 Chief Medical Officer Dr. 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. We look forward to joining forces with R-Biopharm and building on their long-standing experience and expertise in the development of companion and in vitro diagnostic tests."
Apongenix's candidate (APG1010) is a human protein that consists of domains of the CD95 receptor and IgG antibody. It is a CD95 inhibitor that enables a strong immune response against cancerous tumors and malignant hematological diseases.
"This agreement is not only an acknowledgement of our companion diagnostic technology platforms, but also an important strategic step in expanding our companion diagnostics partnerships with leading pharmaceutical companies," said Dr. Frank Apostel, vice president of companion diagnostics at R-Biopharm. "We are very much looking forward to working with Apogenix to support their innovative and promising biopharmaceutical product and help to ensure patient access to this novel treatment as soon as possible.
The agreement comes on the heels of FDA approval of Qiagen's ($QGEN) companion diagnostic for AstraZeneca's ($AZN) lung cancer drug Iressa, as well as Roche's ($RHHBY) companion diagnostic for Pfizer's ($PFE) lung cancer med Xalkori.
In May, Cypher Genomics agreed to use its genome sequencing technology to help Celgene ($CELG) pinpoint genomic biomarkers for drug development while capitalizing on personalized medicine.
- read the release