DGAP-News: MOLOGEN AG: Final results from IMPACT trial with MGN1703 presented at ESMO WCGI 2013
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: Final results from IMPACT trial with MGN1703 presented at
ESMO WCGI 2013
05.07.2013 / 11:55
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PRESS RELEASE N 6 / 2013 of 07/05/2013
MOLOGEN AG: Final results from IMPACT trial with MGN1703 presented at ESMO
WCGI 2013
Berlin, July 5, 2013 - MOLOGEN AG today announced that Prof. Dr.
Hans-Joachim Schmoll has given an oral presentation at ESMO World Congress
on Gastroinstestinal Cancer on the final analysis of the IMPACT trial with
MGN1703. The abstract 'Updated results of the phase 2 IMPACT trial:
Maintenance with MGN1703 vs placebo in patients with advanced colorectal
carcincoma (mCRC)' had been chosen by ESMO to be among the most noteworthy
ones this year.
Prof. Schmoll, study coordinator and Director of the Oncological and
Hematological Department at Martin-Luther-Universitaet Halle-Wittenberg,
presented the results on the primary and secondary endpoints median
progression-free survival (PFS) and overall survival (OS). In addition he
reported on long-term responders which had been observed in the trial.
Moreover, Prof. Schmoll presented new data from a pre-planned analysis on
immunological biomarkers. These data showed that patients selected
according to a certain biomarker, namely Natural Killer T-cells
(NKT-cells), might benefit even more from treatment with MGN1703. The
analysis on patients with a proportion of activated NKT-cells above a
threshold resulted in a PFS hazard ratio of 0.27 with a p-value of 0.007 in
favor of MGN1703.
As reported at the ASCO Annual Meeting 2013, other analyses showed that CEA
normalization and radiological response after induction chemotherapy may
similarly help identify patients with greater benefit when treated with
MGN1703.
Professor Schmoll commented, 'The PFS curves show that a subgroup of
patients may benefit with this innovative treatment approach. Immune cells
activation status or other biomarkers may allow to tailor in the future the
maintenance treatment for metastatic CRC patients.'
'In the IMPACT trial we could show the efficacy of MGN1703 in activating
the immune system and inducing very prolonged responses in a subgroup of
patients, as reported by other immunotherapeutic approaches such as the so
called 'checkpoint blockers'. Differently from these however, we did not
observe any severe auto immune adverse effect, even in patients treated for
more than a year with MGN1703,' stated Dr. Alfredo Zurlo, Chief Medical
Officer of MOLOGEN AG.
In summary the now completed final analysis of the IMPACT study has
strengthened the proof-of-concept for MGN1703 in terms of efficacy and
safety due to the considerably longer follow up. Based on this, MOLOGEN is
currently preparing a pivotal international trial to confirm these results
in a larger number of patients. In parallel, MOLOGEN pushes forwards its
licensing activities for this very promising drug candidate.
About the clinical study with MGN1703 (IMPACT study)
The IMPACT study is a phase 2, randomized, placebo-controlled,
double-blind, multicenter clinical study aiming to determine the efficacy
of MGN1703 as maintenance therapy following first-line chemotherapy with or
without bevacizumab in patients with metastatic colorectal cancer. Patients
included in the IMPACT study had stabilization, or partial or complete
remission of their disease after receiving first-line therapy for 4.5 to 6
months. During the study, patients were randomized to receive either
MGN1703 or placebo twice per week. The treatment was continued until tumor
progression was radiologically confirmed.
Overall 59 patients were enrolled in the study. Patients' characteristics
were globally balanced between treatment groups. The Hazard Ratio (HR) for
Progression-Free Survival on maintenance therapy (primary endpoint of the
study) was 0.56 (p= 0.07) and the HR for Progression-Free Survival from
start of induction therapy (secondary endpoint) was 0.49 (p= 0.03), when
using the assessment of response and progression performed by two
independent reviewers. Taking into account also the assessment by the local
investigators, the HR for Progression-Free Survival on maintenance was 0.55
(p= 0.04) and the HR for Progression-Free Survival from start of induction
therapy was 0.50 (p= 0.02).
Notably, some prolonged responses to treatment with MGN1703 were observed.
As of June 2013 four patients are still not progressing and receiving
MGN1703 in compassionate use in excess of 15-30 months. This pattern of
very prolonged responses is not common with chemotherapy but has been
increasingly reported with other immuno-therapeutic agents in different
tumor types.
About MGN1703
MGN1703 is based on dSLIM(R) ('double Stem Loop Immunomodulator'), an
innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM(R) activates
the immune system against tumor-associated antigens by targeting various
receptors on certain immune cells, primarily TLR9. Tumor-associated
antigens (TAA) are released by cancer cells as a result of chemotherapy and
radiation therapy. Once activated by dSLIM(R), the immune system is able to
overcome its fatal tolerance toward cancer cells and TAA and attacks them
selectively.
Due to this universal mechanism of action, MGN1703 can be applied to
different indications of cancer.
About MOLOGEN AG
MOLOGEN AG is a publicly listed biotechnology company headquartered in
Berlin and specializes in the research and clinical development of
innovative drugs in the fields of oncology and infectious diseases. One of
the company's most important product candidates is the DNA immunomodulator
MGN1703, which is being clinically developed for colorectal cancer and lung
cancer. The cell-based cancer therapy MGN1601 for the treatment of renal
cancer is also currently at the stage of clinical development.
With unique, patented technologies and innovative product developments,
MOLOGEN is one of the leading biotechnology companies in the fields of DNA
medicine and cell-based therapies.
MOLOGEN AG shares (ISIN DE0006637200) are listed in the Prime Standard of
the German Stock Exchange.
www.mologen.com
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(R), dSLIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG.
MOLOGEN AG
PRESS SERVICE:
Prof. Peter W. Huebner
Head of Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
huebner(at)mologen.com
INVESTOR RELATIONS:
Joerg Petrass
Tel: +49 - 30 - 84 17 88 - 13
Fax: +49 - 30 - 84 17 88 - 50
investor(at)mologen.com
External Investor Relations:
Kirchhoff Consult AG
Sebastian Bucher
Tel: +49 - 40 - 60 91 86 - 18
Fax: +49 - 40 - 60 91 86 -16
sebastian.bucher(at)kirchhoff.de
Note about risk for future predictions
Certain information in this report contains forward-looking statements or
the corresponding statements with negation or versions deviating from this
or comparable terminology. These are described as forward-looking
statements. In addition, all of the information given here that refers to
plannedor future results of business areas, key financial figures,
developments of the financial situation or other financial figures or
statistical data, is to be understood as such forward-looking statements.
The company points out to investors that they should not rely on these
forward-looking statements as predictions about actual future events. The
company is not obligated and refuses to accept any liability for the
forward-looking statements and has no obligation to update such statements
in order to accurately reflect the current situation.
End of Corporate News
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Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: info(at)mologen.com
Internet: www.mologen.com
ISIN: DE0006637200
WKN: 663720
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
Stuttgart
End of News DGAP News-Service
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