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MOLOGEN AG: Recruitment for the TEACH study with MGN1703 in HIV-patients completed (news with additional features)

DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: Recruitment for the TEACH study with MGN1703 in
HIV-patients completed (news with additional features)

22.09.2015 / 09:16

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PRESS RELEASE N 15 / 2015 of 09/22/2015

MOLOGEN AG: Recruitment for the TEACH study with MGN1703 in HIV-patients
completed

Berlin, September 22, 2015 - The biotechnology company MOLOGEN AG announced
today that its partner, the Danish Aarhus University Hospital, completed
enrollment of 16 HIV patients for the phase I TEACH study with the
immunotherapy MGN1703. Results are expected in the second quarter of 2016.

The aim of the TEACH study is to see if the immunotherapy with MGN1703 can
activate the innate and adaptive immune system in HIV (Human
Immunodeficiency Virus) patients to enhance killing of the HIV infected
cells. Aarhus University Hospital is conducting the trial in two hospital
centers in Denmark and already received respective funding from the
American Foundation for AIDS Research (amfAR). MOLOGEN is providing the
immunomodulator MGN1703. This is the first time that MGN1703 is evaluated
in patients with diseases other than cancer. Thus the potential range of
applications of the product could be expanded.

"We are pleased that the enrollment for TEACH has been completed and that
treatment with MGN1703 is well tolerated. We look forward to seeing all the
results next year", said Dr. Alfredo Zurlo, Chief Medical Officer of
MOLOGEN AG.

Furthermore, MGN1703 is currently being investigated in the registration
trial IMPALA in colorectal cancer and in the randomized trial IMPULSE in
small cell lung cancer. Both studies are currently enrolling patients.

About TEACH
Initiated beginning of June 2015, TEACH (Toll-like receptor 9 enhancement
of antiviral immunity in chronic HIV infection) is a non-randomized
interventional phase I trial of MGN1703 in HIV-infected patients.
Participants receive four weeks of MGN1703 therapy (60 mg s.c. twice
weekly). During these four weeks, each participant is closely monitored for
the safety and therapeutic effects of the drug. 16 patients participate in
two study centers in Denmark.

The primary endpoint of the study is the change in proportions of activated
natural killer cells in the patients. Secondary study endpoints include,
among others, a collection of safety, virological, immunological and
pharmacodynamic data.

HIV infects the immune system and destroys or affects the proper function