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MOLOGEN AG: First patients enrolled in extension phase of the HIV study TEACH

DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: First patients enrolled in extension phase of the HIV study
TEACH

28.06.2016 / 08:30
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PRESS RELEASE N 09 / 2016 of 06/28/2016

MOLOGEN AG: First patients enrolled in extension phase of the HIV study
TEACH

- Collaboration with Aarhus University Hospital, Denmark

- Extension of phase I study to confirm supportive results of initial
study phase

- Evidence of significant enhancement of antiviral immunity

Berlin, 28 June 2016 - The biotech company MOLOGEN AG (ISIN DE0006637200;
Frankfurt Stock Exchange Prime Standard: MGN) announced today that its
partner, the Danish Aarhus University Hospital, treated the first patients
(FPI) in the extension phase of the TEACH study. In the trial with
MOLOGEN's TLR9 agonist, the Immune Surveillance Reactivator (ISR)
lefitolimod (MGN1703), is tested in HIV positive patients. The initial
study started in June 2015 and it was announced in March 2016 that the
study will be extended based on the broad immune system activation induced
by lefitolimod (MGN1703). This effect was shown by the increased activation
of antiviral immunity in the initial study phase. In conclusion, and
consistent with the underlying hypothesis for the mode of action,
lefitolimod (MGN1703) led to the activation of plasmacytoid dendritic cells
(pDC), natural killer cells (NK) and T cells in HIV positive patients
during antiretroviral therapy (ART). Thus, lefitolimod (MGN1703) could play
a role in the kick and kill concept of HIV eradication. In the first phase
of the trial, patients received one month of treatment. Now, in the
extension phase, a group of patients will receive a longer treatment of six
months with lefitolimod (MGN1703). Final study results are expected to be
available in the first half of 2017.

The aim of the TEACH study is to see whether the immunotherapy with
lefitolimod (MGN1703) can activate the innate and adaptive immune systems
in HIV (Human Immunodeficiency Virus) positive patients to enhance killing
of HIV infected cells. Initial results of the first patients treated in the
trial were presented at the Keystone HIV Symposium (Keystone Symposia on
Molecular and Cellular Biology Conference) in March 2016 in Olympic Valley,
US.
About TEACH
TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic
HIV infection) is a non-randomized interventional phase I/IIa trial to