DGAP-News: MOLOGEN to present next generation of TLR9 agonists at ASGCT 2016

DGAP-News: MOLOGEN AG / Key word(s): Conference
MOLOGEN to present next generation of TLR9 agonists at ASGCT 2016

04.05.2016 / 10:25
The issuer is solely responsible for the content of this announcement.

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PRESS RELEASE N 06 / 2016 of 05/04/2016

MOLOGEN to present next generation of TLR9 agonists at ASGCT 2016

Berlin, 4 May 2016 – The biotech company MOLOGEN AG (ISIN DE0006637200;
Frankfurt Stock Exchange Prime Standard: MGN) will present pre-clinical
data on its EnanDIM(R) technology, a new family of TLR9 agonists and
so-called Immune Surveillance Reactivators (ISR), at the 19th Annual
Meeting of the American Society of Gene and Cell Therapy (ASGCT) in
Washington, U.S. (4-7 May, 2016). The data show that members of the
EnanDIM(R) family broadly activate immune cells, such as monocytes, natural
killer cells (NK cells) and plasmacytoid dendritic cells (pDC), in vitro.
Furthermore, the data reveal no signs of toxicity after the administration
of maximal feasible doses of EnanDIM(R) compounds and confirm
immunomodulatory effects in vivo. These results allow the conclusion that
EnanDIM(R) ISRs have the potential for clinical development in the
treatment of cancer.

EnanDIM(R) (Enantiomeric, DNA-based, ImmunoModulator) represents a new
generation of immunomodulators, so-called Immune Surveillance Reactivators
(ISR). Like the ISR lefitolimod (MGN1703), they belong to the class of TLR9
agonists, and represent follow-up compounds with longer patent protection.

The EnanDIM(R) molecules consist entirely of natural DNA, as is also the
case with lefitolimod (MGN1703). The main difference between the two ISR
families is their molecular structure. Whereas lefitolimod (MGN1703) is
dumbbell-shaped and covalently-closed, EnanDIM(R) molecules have a linear
structure. However, as with lefitolimod (MGN1703), no chemical modification
is needed in order to protect the molecules against degradation by enzymes.
EnanDIM(R) molecules contain the natural, but stereoisomeric form of the
ribose molecules at the end of their backbone, which cannot be recognized
by the DNA-degrading enzymes.

The EnanDIM(R) ISRs promise a broad activation of the immune system with a
good tolerability profile. Due to their characteristic mechanism of action,
EnanDIM(R) molecules have the potential to be applied in various cancer
indications. Additionally, it may be possible to develop selected members
of the EnanDIM(R) family both for monotherapy and in combination with
targeted forms of treatment, such as checkpoint inhibitors and other
immunotherapeutic approaches. Moreover, different members of the EnanDIM(R)
family may also be used in the area of infectious diseases – as HIV in the
future.

“EnanDIM(R) is a promising new generation of TLR9 agonists providing the
basis for good follow- up projects for our lead molecule lefitolimod. The
positive results from the pre-clinical studies encourage us to push forward
the further development of these product candidates”, said Dr. Mariola
Söhngen, CEO of MOLOGEN AG.

Abstract details:
Number: 740
Title: “The TLR9 Agonist EnanDIM – Evaluation of New Enantiometric
Oligonucleotides for Cancer Immunotherapy In Vitro and In Vivo”

Oral Presentation Session:
Date/Time: Saturday 7 May 2016 11:00 am -11:15 am
Session title: Oligonucleotide Therapeutics II
Room: Thurgood Marshall West
For more information on the 19th Annual Meeting of the American Society of
Gene and Cell Therapy (ASGCT) please visit the website:
http://www.asgct.org/meetings-educational-programs/asgct-annual-meetings/2
016-annual-meeting

Furthermore, MOLOGEN will present a poster with corresponding data on the
TLR9 agonist EnanDIM at the 14th Annual Meeting 2016 of the Association for
Cancer Immunotherapy (CIMT) in Mainz, Germany (10-12 May 2016).

Poster details:
Title: “In vitro and in vivo evaluation of the TLR9 agonist EnanDIM for
cancer immunotherapy”
Session: “Improving Immunity” 11 May 3:30 pm-6:00 pm

For more information on the 14th CIMT Annual Meeting please visit the
website: http://www.meeting.cimt.eu/

About EnanDIM(R)
The Immune Surveillance Reactivator (ISR) EnanDIM(R) (Enantiomeric,
DNA-based, ImmunoModulator) is an innovative linear DNA-based TLR9 agonist
in pre-clinical development. It broadly and strongly activates the immune
system. EnanDIM(R) could be used in various cancer indications either as
monotherapy, in combination with targeted therapies and checkpoint
inhibitors, or with other immunotherapeutic approaches. It could also
potentially be used in the field of infectious diseases.

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 ISR lefitolimod
(MGN1703) triggers a broad and strong activation of the immune system. Due
to this mechanism of action, lefitolimod (MGN1703) has the potential to be
applied to various indications. 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) is expected to start within the first half 2016.

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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04.05.2016 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.

The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

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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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