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MOLOGEN AG: Immunological data on renal cancer therapy MGN1601 presented at CIMT - Seite 2

progressed after 48 weeks. The other patient with partial response on
treatment was still free of progression at the end of the study and now
receives treatment in a so-called Named Patient Program (NPP). Potential
predictive biomarkers were identified from pre-treatment characteristics,
which were associated with longer overall survival. Those may allow
identifying patients more likely to benefit from this innovative
vaccination approach with MGN1601.

About the ASET study
ASET (Clinical trial to Assess Safety and Efficacy of a Tumor Vaccine) is a
phase I/II, proof-of-principle, multi-center, open-label, single-arm,
clinical study of the tumor vaccine MGN1601, administered intradermally.
The study was conducted in patients with advanced renal cell carcinoma who
failed multiple previous systemic therapies. The aim of the study was the
assessment of safety and efficacy of the study drug.

About MGN1601
MGN1601 is a therapeutic vaccination to fight advanced renal cancer. It is
a cell-based cancer therapy based on genetically modified, allogeneic tumor
cells. A cell bank established by MOLOGEN AG from human renal cancer cells
forms the basis. These cancer cells from the cell bank, foreign
(allogeneic) to the patients, are "genetically modified" with additional
genetic information with the help of four different MIDGE(R) vectors
developed by MOLOGEN and are combined with the DNA immunomodulator
dSLIM(R), also developed by MOLOGEN, as an adjuvant. The active principle
of the cell-based gene therapy is to induce of a cross-reaction of the
patients' 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 cell 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.

Orphan designation
MOLOGEN AG obtained the orphan designation from the European Medicines