On January 23, 2017 MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) reported first combination data of its TLR9 agonist lefitolimod with checkpoint inhibitors (Press release, Mologen, JAN 23, 2017, View Source [SID1234517532]).
The data show that lefitolimod, a so-called Immune Surveillance Reactivator (ISR), can significantly improve the anti-tumor effect of checkpoint inhibitors, particularly anti-PD-1 and anti-PD-L1 antibodies, and thus prolong survival in murine tumor models. The beneficial effect of the combination of lefitolimod with anti-PD-1 compared to each monotherapeutic approach was confirmed in in-vitro experiments. All these results constitute a first preclinical confirmation of the combination approach of lefitolimod with checkpoint inhibitors in the treatment of cancer.

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"We believe that patients can benefit from the combination of these immunotherapies due to their modes of action complementing each other. The new results are an important proof-of-concept for the combination approach of lefitolimod with checkpoint inhibitors. Consequently, the data open further application possibilities for our lead product, and support our ongoing phase I combination study of lefitolimod with the checkpoint inhibitor Yervoy ", said Dr. Mariola Söhngen, CEO of MOLOGEN AG.

The clinical combination study titled "A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients with Advanced Solid Malignancies" is conducted by MD Anderson Cancer Center (MD Anderson). MOLOGEN provides the Immune Surveillance Reactivator (ISR) lefitolimod and funds the study. Around 50-60 patients will participate in the MD Anderson Cancer Center study in Houston, Texas, U.S.. Patient recruitment began in July 2016 and is expected to be completed at the beginning of 2018.

The primary aim of the study is to determine the best tolerable dose for lefitolimod in combination with Yervoy. The safety of this combination therapy will also be investigated and an expansion phase is planned to evaluate the efficacy of this combination therapy.

Results of the combination of lefitolimod with checkpoint inhibitors in preclinical tumor models have been presented at the Annual 2017 Gastrointestinal Cancers Symposium in San Francisco, USA (January 19-21, 2017).