Detailed study results on colorectal cancer therapy with MGN1703 presented at the ESMO meeting

  • At the meeting of the European Society for Medical Oncology (ESMO) detailed results for the colorectal cancer study with the DNA immunomodulator MGN1703 as maintenance therapy were presented today for the first time to an expert audience of clinical oncologists and cancer researchers.
  • This immunomodulator MGN1703 is the first candidate of a whole new class of substances in colorectal cancer which could now be tested as efficacious in a randomized study.

BERLIN, Germany I October 1, 2012 I The efficacy of the DNA immunomodulator MGN1703 was examined in a randomized, double-blinded and placebo-controlled phase II study. Within the framework of the study patients with metastatic colorectal cancer were treated with MGN1703 – as maintenance therapy – following standard first-line therapy. MOLOGEN conducted a first evaluation of the clinical study in May 2012 and already reported on the key findings. Overall, 59 patients were included in the study, with the first evaluation involving 55 patients. Already in this first evaluation it could be shown in a sub-population (n=46) that the median progression-free survival of the primary endpoint of the study was, at 5.8 months, more than double that of the placebo group at 2.7 months. The progression-free survival describes the period in which a cancer makes no further progress. The difference between the MGN1703 group and the placebo group is statistically significant with a p-value of 0.01. The hazard ratio is 0.39. This means that the risk of a renewed tumor progression in patients treated with MGN1703 when compared to the placebo group was more than halved. The progression-free survival rate after six months - one of the secondary endpoints – was 34% in the MGN1703 group and thus considerably higher than the value of 8% in the placebo group. The difference is also statistically significant with a p-value of 0.01. In addition, the study confirms the excellent safety profile of MGN1703. The treatment was also very well tolerated over long periods. The patients still in the study are currently receiving further treament in accordance with the protocol.

The clinical phase II study implemented by MOLOGEN AG is led by Prof. Dr. Hans-Joachim Schmoll. Professor Schmoll is Director of the University Clinic and Polyclinic for Oncology and Haemotology at the Martin Luther University at Halle-Wittenberg. The data were presented at the ESMO meeting by Prof. Dr. Dirk Arnold, the Medical Director of the Hubertus Wald Tumor Center at the University Clinic of Hamburg-Eppendorf. Both clinical researchers are responsible for the design of the study.

With regard to the results Professor Arnold made the following comment: “These surprisingly positive results are equally highly innovative and clinically relevant in two ways: on the one hand, it is with MGN1703, a DNA immunomodulator, that the first representative of a whole new class of substances in colorectal cancer has been tested as efficacious in a randomized study. And on the other hand, this is the second study ever which has tested the value of a proprietary maintenance therapy after another induction therapy.

On the basis of these data MOLOGEN AG shall coordinate further steps on the way to an authorization with the regulatory authorities for medicines in the United States and Europe. At the same time discussions shall be pursued with potential partners regarding the intended licensing of MGN1703.

Further information on the presentation at the meeting of the ESMO
The lecture by Professor Arnold is entitled ‘Maintenance treatment with immunomodulator MGN1703 following induction with standard 1st line therapy prolongs progression-free survival in patients with metastatic colorectal (mCRC): results of the phase II/III IMPACT trial’.

Further details about the meeting can be found at
www.esmo.org/events/vienna-2012-congress.

About the clinical study with MGN1703 (IMPACT study)
The study is a phase 2, randomized, placebo-controlled, double-blind, multicenter clinical study (IMPACT study) to determine the efficacy of MGN1703 as maintenance therapy following successful first-line therapy in advanced colorectal cancer. Patients included had stabilization, or partial, or complete remission of their bowel cancer from receiving first-line therapy for 4.5 to 6 months, beforehand. The first-line therapy is a typical combination of chemotherapy and bevacizumab, which is typically associated with significant adverse effects. During the study, patients were treated twice per week with MGN1703. In the control arm patients received a placebo. The treatment was continued until tumor progression was radiologically confirmed.

The primary endpoint of the study is to determine progression-free survival of the patient. Secondary study endpoints include determining the overall survival, progression-free and overall survival rates, as well as collecting immunological and pharmacodynamic data.

About MGN1703
MGN1703 is based on dSLIM® (“double Stem Loop Immunomodulator”), an innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM® 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®, 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. An application is currently being submitted for an additional phase 2 clinical study with MGN1703, this time for the treatment of advanced lung cancer (NSCLC). The study should begin immediately after approval.

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.

SOURCE: Mologen
 

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