DGAP-News

MOLOGEN AG: New strategic orientation, successful capital measures and notable study progress in 2016 - Seite 3

Patient recruitment for the phase II IMPULSE trial was already concluded in October 2015. At the end of 2016, the analysis of one-year survival rate in the indication of small-cell lung cancer commenced. The initial results of this exploratory study, which investigates the possible treatment success in different patient sub-groups, are expected to be ready in the second quarter of 2017. The results of the follow-up analysis of patients (two-year survival rate) according to protocol will be available in around one year.

MOLOGEN is working together with the Danish Aarhus University Hospital to conduct the phase I/II TEACH study, which is the first time that lefitolimod is being clinically evaluated in patients with a disease other than cancer: HIV. Owing to the favorable results in the first phase of the study, in which a broad activation of the immune system triggered by lefitolimod was observed, the decision was made to continue the study in an extension phase where patients would receive treatment over a longer time frame. Patient recruitment started in June 2016 and the first study results are expected presumably in the middle of 2017. In February of this year, Aarhus University presented further data from the TEACH study, which revealed through colon biopsies that lefitolimod can trigger a local antiviral immune response in patients with HIV who undergo antiretroviral treatment (ART) without inducing inflammation. Consequently, lefitolimod might be used in a "kick and kill" approach.

The U.S. biopharmaceutical company Gilead Sciences, Inc. recently issued a grant of US$ 2.75 million to Aarhus University for a further combination study in which lefitolimod will be investigated together with innovative virus-neutralizing antibodies that have been developed by the Rockefeller University in New York, USA. This innovative combination will be the latest approach in the "kick and kill" concept for the treatment of HIV.

First positive results from combination study with lefitolimod - expansion of application spectrum

For the first combination study of lefitolimod with the checkpoint inhibitor Yervoy^(R) (ipilimumab), which MOLOGEN is carrying out in cooperation with the MD Anderson Cancer Center, Texas, patient recruitment started in July 2016. Through the combination of these two immunotherapies, the aim is to generate a broader activation of the immune system and synergy effects.