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MOLOGEN AG: Expanded manufacturing authorisation for MIDGE®-based active substances
After detailed inspections, the responsible authorities have confirmed that the production and quality of the active substances meets the requirements of the German Medicinal Products Act (AMG) and the GMP guidelines (GMP: Good Manufacturing Practice). The manufacturing authorisation is no longer linked to individual active substances, but applies generally to the MIDGE® production process.
New active substances must merely be reported to the authorities. A separate, very time-intensive application for individual active substances is no longer required. The active substances which are produced for clinical trial products may be used in clinical studies up to and including Phase II.
The manufacturing authorisation marks the successful completion of process optimisations with the objective of being able to produce sufficient quantities of DNA active substances for clinical studies in the required quality itself.
The production process for dSLIM®-based active substances as they are currently being used in the clinical trial Phase I with MGN1703 was also inspected in detail in the course of the inspection process. Here as well, compliance with the AMG and the GMP guidelines in production and quality was confirmed.
The granting of the general manufacturing authorisation documents the extensive know-how of MOLOGEN in handling DNA-based active substances.
MOLOGEN AG with its clinical development programs for DNA pharmaceuticals is among the leading biotechnology companies in the field of DNA medicine.
''We have attained an important goal with the granting of the expanded manufacturing authorisation. We can now ourselves produce the DNA active substances that are required for our clinical development programs in the required quality and amounts'', Dr. Matthias Schroff, CEO of MOLOGEN AG, explained.
Information about the clinical study with MGN1703
The study (Phase I) of the safety, compatibility and immunological effect of MGN1703 in the treatment of various cancers is a major milestone for a comprehensive clinical development program. The study is currently performed at the renowned cancer centers in university hospitals in Essen and Cologne. MOLOGEN plans to establish an effective, compatible treatment for the treatment of the most frequent cancers in the form of MGN1703.
dSLIM® - an innovative TLR9 agonist
In dSLIM® ("double Stem Loop Immunomodulator"), MOLOGEN has developed an innovative TLR9 agonist. Use of dSLIM® activates the immune system against tumor-associated antigens by targeting the different receptors, primarily TLR9, on certain immune cells. As a result of chemotherapy and radiotherapy, tumor-associated antigens (TAA) are released by cancer cells. The immune system activated by dSLIM® is in a position to overcome its fatal tolerance towards cancer cells and TAA and advance against them strategically.
MIDGE® - the basis for novel DNA vaccines
In biotechnology, delivery vehicles for the transmission of nucleic acids (primarily DNA) are called vectors. The MIDGE® (Minimalistic Immunogenically Defined Gene Expression) technology developed by MOLOGEN is also described as a DNA vector. In contrast to other DNA vectors (plasmids, viruses), the MIDGE® vector only contains the information necessary for the actual action. It is free of undesirable structures that are only used for the manufacturing process.
MIDGE® created the basis for a broad spectrum of modern DNA-based applications. These vectors are designed with a variety of individualized properties and are exceptionally well suited for DNA-based vaccination against infectious diseases like Leishmaniasis.
Disclaimer concerning prognoses
Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial classification numbers, developments of the financial situation, or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.
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