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Mologen says phase II/III study for colorectal cancer medicine MGN1703 launched, dynamics of R&D activities continue in Q3
Berlin | Monday, November 15, 2010, 11:00 Hrs  [IST]

Mologen AG very successfully continued its activities in the third quarter 2010. As the company reported its quarterly numbers, in the past nine month the focus of its R&D activities was on the preparation and execution of the clinical phase II/III study with the DNA-based colorectal cancer medicine MGN1703. In the previously completed phase I b study, the medicine had already shown its positive safety profile. An additional analysis sequence of the data proved, based on biomarkers, a broad activation of the immune system in the patients, which significantly exceeded the expectations of the experts. The scientific concept of dSLIM, the molecule on which MGN1703 is based, has thus again been confirmed.

In our other current research projects, progress proceeded as planned. Mologen AG continued the preparations for the clinical phase I/II study with the cell-based gene therapy for the treatment of renal cancer, MGN1601. First results of the pre-clinical tests with the newly developed Midge based DNA vaccine against Leishmaniasis in humans was presented in September at the Institute Pasteur in Paris. Moreover, Mologen AG in cooperation with the Dutch company Synvolux Therapeutics B. V. launched a further research project for the development of a new, highly effective vaccine against an infection caused by Hepatitis-B viruses. The necessary financing was secured with funding from the Federal Ministry of Education and Research as part of the EuroTrans-Bio-Initiative of the European Union.

In the first nine months of the financial year 2010, revenues of Mologen AG were EUR 67 thousand and were, as expected and similar to the first nine months of the previous year, on a low level (comparison period: EUR 45 thousand). Other operating income, which mainly consisted of subsidies, was significantly lower at EUR 135 thousand than in the previous year (EUR 306 thousand) since fewer subsidies were received in the reporting period.

In the reporting period, the deficit increased by EUR 830 thousand to EUR -4.5 million (comparison period: EUR -3.6 million). The main cause for this result was, aside from lower other income, higher expenditures for materials and an increase in other operating expenses as well as an increase in personnel expenses. The R&D expenditures amounted to a total of EUR 3.2 million in the reporting period which represents a significant increase compared to the reference period (EUR 2.4 million).

Income from financing activities in the reporting period was EUR 4.3 million. Assets contain a large percentage of liquid assets; EUR 6,107 thousand as of the reporting date. The liquid assets available will be sufficient to continue with all scheduled activities and clinical studies into the year 2011, if the development proceeds as planned. The equity ratio at the end of the third quarter was 89% and thus higher than the ratio at the end of 2009 (86%).

Die 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. The company is globally one of the few biotechnology companies with well tolerated DNA-based cancer treatment in the clinical development phase.

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