On July 28, 2015 Apogenix, a next generation immuno-oncology company, reported that it has entered into an agreement with R-Biopharm, a global provider of innovative clinical diagnostics, to develop companion diagnostic tests for Apogenix’ lead drug candidate APG101 (Press release, Apogenix, JUL 28, 2015, View Source [SID1234524546]). APG101 is a CD95 ligand inhibitor which restores the body’s immune response against tumors and inhibits invasive tumor cell growth. The drug candidate is being developed for the treatment of solid tumors and malignant hematological diseases.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In a controlled phase II efficacy trial in patients with recurrent glioblastoma, treatment with APG101 in combination with radiotherapy has demonstrated clinical superiority in all study endpoints compared to treatment with radiotherapy alone. Glioblastoma patients with a certain biomarker associated with the CD95 ligand experienced the greatest benefit from treatment with APG101. The trial showed a statistically significant prolongation of overall survival in biomarker-positive patients treated with APG101, with a median overall survival of 16.1 months compared to 7.3 months in patients treated with radiotherapy alone.
Based on different test technologies including immunohistochemistry (IHC) and polymerase chain reaction (PCR), Apogenix and R-Biopharm will develop patient-stratifying companion diagnostic tests to identify glioblastoma patients who are most likely to benefit from treatment with APG101. The cooperation further includes the development of in vitro diagnostic tests to determine expression of the CD95 ligand in other types of tumors. Apogenix will validate the resulting diagnostic tests in a pivotal phase II/III trial in glioblastoma and in additional clinical trials for the treatment of other solid tumors.
"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, " said Harald Fricke, M.D., Chief Medical Officer of Apogenix. "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."
"As a leading diagnostics partner in developing clinical test systems, R-Biopharm is passionate about bringing new diagnostic opportunities to the field of personalized medicine. 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 Companion Diagnostics of 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."