DGAP-News: MOLOGEN presents first anti-tumor data of the product candidate and TLR9 agonist EnanDIM(R) in a murine tumor model

DGAP-News: MOLOGEN AG / Key word(s): Conference
MOLOGEN presents first anti-tumor data of the product candidate and TLR9
agonist EnanDIM(R) in a murine tumor model

12.09.2016 / 09:16
The issuer is solely responsible for the content of this announcement.

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PRESS RELEASE N 14 / 2016 of 09/12/2016

MOLOGEN presents first anti-tumor data of the product candidate and TLR9
agonist EnanDIM(R) in a murine tumor model

Berlin, 12 September 2016 – The biotech company MOLOGEN AG (ISIN
DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today
first preliminary data on its EnanDIM(R) technology in a murine tumor
model. EnanDIM(R) is a new family of TLR9 agonists and so-called Immune
Surveillance Reactivators (ISR). The pre-clinical in vivo data shows that
EnanDIM(R) can reduce tumor growth and thus prolong survival. It has been
shown previously that EnanDIM(R) molecules broadly activate immune cells in
vitro and revealed no signs of toxicity after the administration of maximal
feasible doses in vivo. These data constitute the next pre-clinical step
towards a clinical development program of EnanDIM(R) in the treatment of
cancer.

“This is the next important step for our promising new generation TLR9
agonist EnanDIM(R). For the first time we observed reduced tumor growth in
a murine model. These results strongly support the pre-clinical development
of our EnanDIM(R) compounds”, said Dr Mariola Söhngen, CEO of MOLOGEN AG.

MOLOGEN’s new strategy program “Next Level”, presented beginning of June
2016, includes a clear concentration on the lead product, the cancer
immunotherapy lefitolimod and next-generation molecules EnanDIM(R).

EnanDIM(R) (Enantiomeric, DNA-based, ImmunoModulator), as a new generation
of immunomodulators and so-called Immune Surveillance Reactivators (ISR),
belongs to the class of TLR9 agonists and represents one of MOLOGEN’s
follow-up compounds to lefitolimod (MGN1703) exhibiting longer patent
protection, and a one-step production process as well as an
immunomodulatory pattern dependent on the specific EnanDIM(R) molecule.

The EnanDIM(R) molecules consist entirely of natural DNA, as is also the
case with lefitolimod (MGN1703). The main difference between MOLOGEN’s two
ISR families is their molecule structure. Whereas lefitolimod (MGN1703) is
dumbbell-shaped and covalently-closed, EnanDIM(R) molecules have a linear
structure. However, as with lefitolimod (MGN1703), due to its specific
structure, no chemical modification is needed in order to protect the
molecules against degradation by enzymes.

The EnanDIM(R) ISR promise a broad activation of the immune system with a
good safety and 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 – including HIV.

The data will be presented at the Second CRI-CIMT-EATI-AACR International
Cancer Immunotherapy Conference in New York, USA (September 25-28, 2016).
The conference will be organized by the Cancer Research Institute (CRI),
die Association for Cancer lmmunotherapy (CIMT), the European Academy of
Tumor Immunology (EATI), and the American Association for Cancer Research
(AACR).

Abstract details:
Abstract number: # 278
Title: “Preclinical data of novel enantiomeric oligonucleotides for cancer
immunotherapy: The TLR9 agonist EnanDIM”
Poster presentation: September 26, from 5:15-7:45 pm
Poster Number: B067

For more information on the Second CRI-CIMT-EATI-AACR International Cancer
Immunotherapy Conference please visit the website: http://www.aacr.org.

About EnanDIM(R)
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 other
targeted therapies or immune modulators, such as so called 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 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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12.09.2016 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.
Archive at 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, Tradegate Exchange

End of News DGAP News Service
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500731 12.09.2016

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