DGAP-News: R-Biopharm and Apogenix Enter Cooperation to Develop Companion Diagnostic Tests for Apogenix' Immuno-Oncology Candidate APG101

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

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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



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