Mologen AG announced that further immunological data from the phase I/II ASET renal cancer study with MGN1601 have been presented in a poster at the 12th CIMT Annual Meeting (The Association for Cancer Immunotherapy) in Mainz, Germany. The activation of the immune system after treatment with the tumor cell-based cancer vaccine MGN1601 reflects the expected mode-of-action and was supported by the immunological findings. Furthermore, a good safety profile and promising median overall survival data in a subgroup of patients were demonstrated.

One patient remained up to 48 weeks with stable disease and another patient achieved a long-term partial response of more than 120 weeks. In the trial 19 heavily pretreated patients with advanced renal cancer were enrolled to assess safety, tolerability and immunological effects of MGN1601. The evaluation of T-cell responses in subgroups of patients showed first evidence of cytotoxic antitumor immune response after MGN1601 vaccination.

Moreover, significant improvement of the cellular immune function during the course of the treatment was observed. The monotherapy with tumor cell-based cancer vaccine MGN1601 was well tolerated and safe. Furthermore, treatment with MGN1601 resulted in promising median overall survival of 115.3 weeks in a subgroup of patients who completed the study per protocol.

Overall, two patients achieved prolonged disease control. One patient with stable disease eventually 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.