DGAP-News: 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
The issuer is solely responsible for the content of this announcement.

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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
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
is also being investigated in a phase I study in HIV and a phase I
combination study with the checkpoint inhibitor Yervoy(R) (ipilimumab),
which is expected to start shortly. Next to checkpoint inhibitors,
lefitolimod is one of the few product candidates that are in a phase III
clinical trial (IMPALA) in the field of immuno-oncology and close to
reaching the market.

MOLOGEN's pipeline focus is on new, innovative immunotherapies to treat
diseases for which there is a high medical need.

www.mologen.com

Memberships in associations:
Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V.
|  DECHEMA - Society for chemical technology and biotechnology e.V.  |
German industrial association of biotechnology (DIB)  |  Association for
the Promotion of Science and Humanities in Germany  |  Association of
German biotechnology companies (VBU)  |  Association of researching
manufacturers of pharmaceuticals e.V. (VFA)  |  Association of the chemical
industry e.V. (VCI)

MIDGE(R), dSLIM(R), EnanDIM(R) and MOLOGEN(R) are registered trademarks of
MOLOGEN AG.

Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com

Note about risk for future predictions
Certain information in this report contains forward-looking statements or
the corresponding statements with negation or versions deviating from this
or comparable terminology. These are described as forward-looking
statements. In addition, all of the information given here that refers to
planned or future results of business areas, key financial figures,
developments of the financial situation or other financial figures or
statistical data, is to be understood as such forward-looking statements.
The company points out to investors that they should not rely on these
forward-looking statements as predictions about actual future events. The
company is not obligated and refuses to accept any liability for the
forward-looking statements and has no obligation to update such statements
in order to accurately reflect the current situation.


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28.06.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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   Language:    English                                                    
   Company:     MOLOGEN AG                                                 
                Fabeckstraße 30                                            
                14195 Berlin                                               
                Germany                                                    
   Phone:       030 / 841788-0                                             
   Fax:         030 / 841788-50                                            
   E-mail:      presse@mologen.com                                         
   Internet:    www.mologen.com                                            
   ISIN:        DE0006637200                                               
   WKN:         663720                                                     
   Listed:      Regulated Market in Frankfurt (Prime Standard); Regulated  
                Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,  
                Stuttgart                                                  
 
 
   End of News    DGAP News Service  
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474899 28.06.2016