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MOLOGEN AG: First patients enrolled in extension phase of the HIV study TEACH - Seite 2

evaluate lefitolimod (MGN1703) in HIV positive patients. In the first phase
of the study, 15 participants received four weeks of lefitolimod (MGN1703)
therapy (60 mg s.c. twice weekly). The extension phase is planned to
include 15 patients, too, who will be treated for six months with
lefitolimod. During the treatment period, each participant is closely
monitored for safety and therapeutic effects of the drug. Aarhus University
Hospital, Denmark is conducting the trial in two hospital centers in
Denmark, for which it received funding from the American Foundation for
AIDS research (amfAR). MOLOGEN is providing the Immune Surveillance
Reactivator (ISR) lefitolimod (MGN1703).

The primary endpoint of the first study treatment phase is the change in
proportions of activated natural killer cells in patients. Secondary study
endpoints include, among others, a collection of safety, virological,
immunological and pharmacodynamic data. In the extension phase the change
in HIV-DNA in circulating T cells will be assessed as primary endpoint.
Main secondary endpoints are - besides safety evaluation - changes of
functional immune parameters.

HIV infects the immune system and destroys or affects the proper function
of immune cells. Without antiretroviral treatment, this eventually leads to
immune deficiency and the immune system can no longer fend off a wide range
of infections and diseases. HIV remains a serious worldwide health issue.
According to estimates by WHO and UNAIDS (United Nations Programme on AIDS)
37 million people worldwide were living with HIV at the end of 2014. Some 2
million people became newly infected in that same year, and 1.2 million
died as a result of HIV-related causes globally.

MOLOGEN AG
With new and unique technologies and active substances, the biotech company
MOLOGEN is one of the pioneers in the field of immunotherapy. Alongside a
focus on immuno-oncology, MOLOGEN also develops immunotherapies for the
treatment of infectious diseases.

The cancer immunotherapy lefitolimod (MGN1703) is the company's lead
product and best-in-class TLR9 agonist. Treatment with lefitolimod
(MGN1703) triggers a broad and strong activation of the immune system. Due
to this mode of action, namely to reactivate the monitoring function of the
immune system, lefitolimod (MGN1703) can be recognized as an Immune
Surveillance Reactivator (ISR). It has the potential to be applied to
various indications. ISR lefitolimod (MGN1703) is currently being developed
for first-line maintenance treatment of colorectal cancer (pivotal study)
and small cell lung cancer (randomized controlled trial). Furthermore, it