DGAP-News: R-Biopharm AG / Key word(s): Alliance/Miscellaneous R-Biopharm and Apogenix Enter Cooperation to Develop Companion Diagnostic Tests for Apogenix' Immuno-Oncology Candidate APG101 28.07.2015 / 10:00 --------------------------------------------------------------------- R-Biopharm and Apogenix Enter Cooperation to Develop Companion Diagnostic Tests for Apogenix' Immuno-Oncology Candidate APG101 - R-Biopharm strengthens its position in the field of companion diagnostics - Cooperation represents a further endorsement of R-Biopharm's companion diagnostic technologies Darmstadt, Germany, July 28th, 2015 - R-Biopharm AG, a global provider of innovative clinical diagnostics, announced today that it has entered into a research and development cooperation with Apogenix GmbH, a next generation immuno-oncology company, for the development of companion diagnostic tests (CDx) for Apogenix' lead product APG101, a novel targeted anti-cancer therapy. Financial details were not disclosed. Apogenix' APG101 is a CD95 ligand-binding fusion protein. Final data from the randomized, controlled phase II efficacy trial in patients with recurrent glioblastoma clearly demonstrated the clinical superiority of APG101 in combination with radiotherapy in all study endpoints compared to treatment with radiotherapy alone. In addition, glioblastoma patients who express 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. Built on a toolbox of different test technologies including immunohistochemistry, and polymerase chain reaction (PCR), R-Biopharm and Apogenix will develop patient-stratifying CDx tests to identify patients who are most likely to benefit from treatment with APG101. To achieve fast results and identify the best approach, R-Biopharm is planning to run several CDx development programs in parallel. The corresponding CDx tests will then be used and validated by Apogenix in a pivotal clinical trial in glioblastoma and in additional clinical trials for the treatment of other solid tumors. "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." "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." Glioblastoma multiforme or gliobastoma (GBM) is the most common and most aggressive malignant primary brain tumor in humans, accounting for 52% of all functional tissue brain tumor cases and 20% of all intracranial tumors. The prognosis for glioblastoma is extremely poor since recurrence is almost universal (>90%) following primary standard treatment. About 50% of glioblastoma patients die within one year, while 90% die within three years. About Companion Diagnostics Today, it is widely accepted that patients react differently to drugs not only due to factors such as age or weight but also depending on inherent diversities of their genetic makeup. An effective treatment for one person may not work for someone else or may even cause an adverse reaction. Companion diagnostic tests enable the development of new therapeutics for particular populations and help doctors customize treatments to achieve the best possible results. Instead of a trial-and-error approach, physicians can immediately choose the most effective medication with the fewest side-effects, while at the same time reducing healthcare costs. In addition, the concept of companion diagnostics opens up new latitudes to ensure value and generate a competitive edge for pharmaceutical and biotech products. With the opportunity to preselect patients for clinical trials, companion diagnostics can help to reduce overall development costs, time and simultaneously increase efficiency and efficacy of a specific drug candidate. Even if a drug is already approved, companion diagnostics may increase market share based on the significantly increased response rate when prescribed to a defined group of patients. R-Biopharm has long-term experience in the development of test systems for clinical diagnostics based on various technology platforms and commercializes innovative diagnostic tests. R-Biopharm offers co-development programs for personalized healthcare as a trusted partner to pharmaceutical and biotechnology companies, enabling and supporting their efforts to bring the most effective personalized therapies to global markets. www.companion-diagnostics.com About R-Biopharm AG R-Biopharm AG (Darmstadt, Germany) is a globally active life science company and a leading provider of reliable test systems for clinical diagnostics and for analyzing human food and animal feedstuffs. Since 1988, R-Biopharm has been developing innovative products characterized by top quality, reliability and efficiency. A strong sense of responsibility, long-standing experience and a network of 21 affiliated companies and subsidiaries in the US, Europe, South America, China and Australia, as well as more than 100 distribution partners, make R-Biopharm a prime partner for clients from retail, industry and public institutions looking for answers and solutions for current analytical challenges. Please contact: R-Biopharm AG Companion Diagnostics Dr. Frank Apostel, Vice President Companion Diagnostics An der neuen Bergstrasse 17 64297 Darmstadt, Germany Phone: +49 (0) 61 51 - 81 02-537 E-mail: f.apostel@r-biopharm.de www.r-biopharm.com www.companion-diagnostics.com --------------------------------------------------------------------- 28.07.2015 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------- 381305 28.07.2015
DGAP-News: R-Biopharm and Apogenix Enter Cooperation to Develop Companion Diagnostic Tests for Apogenix' Immuno-Oncology Candidate APG101
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