04.05.2016 10:25:16

DGAP-News: MOLOGEN AG

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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