DGAP-News: MOLOGEN AG
/ Key word(s): Study
04.11.2019 / 11:59
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PRESS RELEASE N 19 / 2019 of 11/04/2019
MOLOGEN AG announces start of phase IIa TITAN combination study in HIV
Berlin, 4 November 2019 – The biopharmaceutical company MOLOGEN AG
“We are obviously very excited to be enrolling first participants in this innovative randomized trial. The placebo-controlled study design allows us to dissect the impact of two types of very promising investigational drugs on the HIV reservoir and the immune system”, said Prof Dr Ole Schmeltz Søgaard, principle investigator in the TITAN study.
Chief Medical Officer, Dr. Matthias Baumann stated: “We are delighted to announce the start of this phase IIa combination trial with our TLR9 agonist lefitolimod. The TITAN study builds on the learnings from our TEACH trial and is an important step in our new strategy to investigate lefitolimod in combination approaches also in HIV.”
In the phase Ib/IIa TEACH study, lefitolimod was tested as a monotherapeutic approach on top of standard anti-retroviral therapy or ART in HIV patients. There was clear evidence for the impressive effects of lefitolimod in regard to the reactivation of the immune system. These data, coupled with the confirmed favorable safety profile, forms the basis for even more advanced therapeutic combination strategies, e.g. the TITAN study. The hypothesis in the TITAN trial is that the combination of lefitolimod and the broadly neutralizing monoclonal antibodies will boost immunological control of the HIV infection and lead to a delay in time to viral rebound once participants interrupt their regular HIV medication.
About the TITAN study
Forty-eight patients will participate in the study; randomization and dosing of participants began on 30 October 2019. The study is expected to be completed in early 2021.
The focus of MOLOGEN’s development is on DNA-based TLR9 agonists. This includes the lead compound, the immunotherapy lefitolimod, and its next generation molecules EnanDIM(R), building the foundation for a next generation immunotherapy platform in areas of unmet need.
Forthcoming milestones include: the start of the clinical development of EnanDIM(R) and additional combination studies in cancer, including one with our strategic partner Oncologie Inc., which are in an advanced planning stage.
MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The shares (ISIN, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the German Stock Exchange.
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