Specialized immuno-oncology company, Apogenix, recently announced a new agreement with R-Biopharm, a multinational provider of novel clinical diagnostics, to create complementary tests for Apogenix’ flagship pipeline product, APG101 – a CD95 ligand inhibitor that works to boost the body’s immune response against tumors while inhibiting cell growth. APG101 is currently undergoing tests as a potential treatment for solid tumors and malignant hematological diseases.
Findings from a controlled Phase II study involving patients with recurrent glioblastoma showed a combined treatment with APG101 and radiotherapy yielded clinically superior benefits in all study endpoints, compared to monotherapy with radiation. Patients who had a specific biomarker linked to the CD95 ligand respond better to the drug and had a prolonged overall survival by an average of 16.1 months, compared to 7.3 months in patients who received radiotherapy alone.
Using technologies that underlie certain tests, such as immunohistochemistry (IHC) and polymerase chain reaction (PCR), the two companies intend to develop patient-stratifying diagnostics to determine which glioblastoma patients are most likely to respond better to APG101. The partnership also covers the advancement of in vitro tests that determine CD95 expression in other types of cancer. Apogenix will be validating the efficacy of resulting tests in a Phase II/III trial on glioblastoma and other types of 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.”