MOLOGEN AG: Treatment with renal cancer therapy MGN1601 generates clear survival benefit for patients
- First evaluation of survival
times provides results that exceed expectations
- Immunological active principle proven in an exemplary
manner
- Data presented at the annual meeting of the American Association
for Cancer Research
In a further evaluation of the phase I/II renal cancer study with
MGN1601, the biotechnology company MOLOGEN AG has analyzed the
survival times of patients enrolled in the study and the first data
of the accompanying immunological tests. The result: patients that
were able to completely finish the twelve-week therapy scheme
scheduled in the study protocol with the study drug MGN1601 (PP
group) have an unexpectedly clear survival benefit in comparison
with patients that had to terminate their study therapy early
(non-PP group).
Thus far, the ten patients in the PP group already
survived more than ten months on average. Since only one patient in
this group has died by now, this parameter will continue to
improve. In the non-PP group, the median survival time is a little
over two months; all nine patients had died at the latest after six
months. With regard to historical clinical data and statistical
models, a median survival time of five to seven months was
expected. Hence, this was clearly exceeded in this study.
Furthermore it is very remarkable that for two patients who are
currently being treated in the extension phase of the study at
fixed intervals, the disease has not progressed in over ten
months.
Immunological principle proven in an exemplary manner
With the evaluation of immunological data it was possible to prove
in an exemplary manner that those patients that completed the
entire planned three-month treatment cycle with MGN1601 in
accordance with the study protocol have generated a clear immune
response. The strength of the immune response increased with
continued treatment. With these results, the mechanism of action
demonstrated in preclinical studies could also be confirmed in
patients. In the view of MOLOGEN AG, the observed positive effects
with respect to overall survival can thus be attributed to the
treatment with MGN1601.
Concurrently to the evaluation of the study, MOLOGEN has also
applied for scientific advice at the Paul-Ehrlich-Institut, to
discuss, amongst others, questions relating to the design of future
clinical studies. Subsequent clinical studies with MGN1601 will
then be applied for.
Prof. Dr. Burghardt Wittig, Chairman of the Scientific Advisory
Board of MOLOGEN AG, states: "As a scientist, I am delighted that
our molecular biological and immunological concepts for active
therapeutic vaccination against cancer were able to prove their
efficacy so impressively with MGN1601. I find it particularly
noteworthy that we were now able to clearly show what we had
hitherto only been able to assume: active immunotherapies against
cancer, like MGN1601, need time before they can show their effect.
Tragically, all patients for whom the therapy with MGN1601 came too
late have already died, while all other patients - apart from one,
who survived for more than eleven months - are still alive
today."
Dr. Matthias Schroff, Chief Executive Officer at MOLOGEN AG, adds:
"It is a very positive surprise that our second oncological product
candidate MGN1601 is already showing such excellent efficacy data
in phase I/II. Thereby, our product pipeline has taken a great step
forward. For this reason I am very confident with regard to our
further clinical studies, both for MGN1703, our immunomodulator,
which we are applying in the field of colorectal cancer and lung
cancer, and also for MGN1601, our renal cancer therapy."
Presentation at the annual congress of the American Association
for Cancer Research
MOLOGEN project manager Ekaterina
Weith is to present the data together with Prof. Dr. Burghardt
Wittig (Chairman of the Scientific Advisory Board of MOLOGEN AG) at
the annual meeting of the American Association for Cancer Research
(AACR) as part of a "Late-Breaking Poster Session" on April 3, 2012
in Chicago, USA (poster no. LB-233). The AACR is the world's oldest
and largest scientific organization that is dedicated to all
aspects of high-quality, innovative cancer research.
About the phase I/II clinical study (ASET study)
Within
the framework of the ASET study, patients receive a total of eight
treatments with MGN1601 over a period of twelve weeks. The patients
are examined after completion of the treatment phase. If the
patients have at least responded to the treatment with
stabilization of the originally progressing cancer disease after
twelve weeks, they can be treated further within an extension
phase. In this extension phase, the patients receive up to five
further treatments distributed over two years at increasing
intervals. As reported, patient recruitment was finalized ahead of
schedule after acceptance of 19 patients into the study, since it
had already been possible to achieve the primary goal of the study,
namely to verify the safety and tolerability of the compound.
About MGN1601
The tumor therapy with MGN1601 is a
therapeutic vaccination to fight advanced renal cancer and to
prevent their recurrence after operation and medical
treatment.
MGN1601 is a cell-based cancer therapy based on genetically
modified tumor cells. A cell bank established by MOLOGEN AG from
human renal cancer cells in accordance with pharmaceutical
regulations forms the basis. These cancer cells from the cell bank,
foreign (allogeneic) to the patient, are "genetically modified"
with additional genetic information with the help of four different
MIDGE® vectors developed by MOLOGEN and are combined with the
DNA immunomodulator dSLIM®, also developed by MOLOGEN, as an
adjuvant.
The active principle of the cell-based gene therapy involves
induction of a cross-reaction of the patient's immune system
against their own cancer cells after the immune system has learned
what cancer cells typically look like via its response to the
genetically-modified foreign cancer cells.
About renal cancer
Renal cancer is the most frequently
occurring malignant tumor of the kidneys with 200,000 incidences
annually throughout the world. According to the Robert Koch
Institute, there are 15,000 patients affected by this disease in
Germany alone. Among these patients, around 30% already have
distant metastases at the time of initial diagnosis, which
significantly reduces the success of a therapy. The tumor is known
for not responding to radiation or chemotherapy. The use of
medications which are currently available on the market are
accompanied by considerable side effects. Thus there is still a
great medical need for new, effective medications with low side
effects for the treatment of renal cancer. Exactly this approach is
followed with MGN1601.
Orphan Drug Status
The cell-based gene therapy against renal cancer has received the
Orphan Drug Status from the European Medical Agency (EMA). This
enables MOLOGEN AG to market the product exclusively within the
European Union within a period of ten years. The Orphan Drug
Program of the European Union is supposed to promote the
development of therapies for rare and serious diseases.
About MOLOGEN AG
MOLOGEN AG, a German
biopharmaceutical company with headquarters in Berlin specializes
in the research and development of innovative medications on the
basis of DNA structures. The activities focus on numerous product
developments which are relevant to the immune system; on the one
hand vaccines against infectious diseases and on the other hand
cancer medications. MOLOGEN AG is globally one of the few
biotechnology companies with well tolerated DNA-based cancer
treatment in the clinical development phase.
The stocks of MOLOGEN AG are listed in the Prime Standard of the
German stock exchange (ISIN DE0006637200).
Memberships in associations:
Biotechnologieverbund
Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V. | DECHEMA -
Society for chemical technology and biotechnology e.V. | German
industrial association of biotechnology (DIB) | Association for the
Promotion of Science and Humanities in Germany | Association of
German biotechnology companies (VBU) | Association of researching
manufacturers of pharmaceuticals e.V. (VFA) | Association of the
chemical industry e.V. (VCI)
MIDGE®, dSLIM® and MOLOGEN® are registered trademarks
of MOLOGEN AG.
www.mologen.com
MOLOGEN AG
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Sebastian Bucher
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Prof. Peter W. Huebner
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Tel: +49 - 30 - 84 17 88 - 38
Tel: +49 - 30 - 84 17 88 - 50
Posted: March 2012
