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MOLOGEN AG: First combination data of TLR9 agonists EnanDIM(R) with checkpoint inhibitor in preclinical tumor models

(February 27, 2017)

DGAP-News: MOLOGEN AG / Key word(s): Conference

27.02.2017 / 10:01
The issuer is solely responsible for the content of this announcement.

Press Release N 7 / 2017 of 02/27/2017

MOLOGEN AG: First combination data of TLR9 agonists EnanDIM(R) with checkpoint inhibitor in preclinical tumor models

Berlin, 27 February 2017 - The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today first combination data of its TLR9 agonists EnanDIM(R) with a checkpoint inhibitor. EnanDIM(R) is a new family of TLR9 agonists and socalled Immune Surveillance Reactivators (ISR). The preclinical in vivo data showed that EnanDIM(R) can significantly improve the anti-tumor effect of the checkpoint inhibitor anti-PD-1, and thus prolong survival in a murine colon carcinoma tumor model. The beneficial effect of the combination of EnanDIM(R) with anti-PD-1 antibodies compared to each monotherapeutic approach was confirmed in in vitro experiments. These results constitute a first preclinical confirmation of the combination approach of EnanDIM(R) with checkpoint inhibitors in the treatment of cancer.

"We believe that patients can benefit from the combination of these immunotherapeutic approaches due to the fact that their modes of action complement each other. These new results are an important proof-of-concept for the strategy to combine EnanDIM(R) with checkpoint inhibitors. The same is true for our lead compound lefitolimod - we just recently presented the findings at an important international scientific conference. Consequently, the data open further application possibilities for our TLR9 product family", said Dr. Mariola Söhngen, CEO of MOLOGEN AG.

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

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

The new findings support the strategy to combine TLR9 agonists with checkpoint inhibitors - which is the concept of MOLOGEN's currently ongoing phase I combination study of lefitolimod with the checkpoint inhibitor Yervoy(R) (ipilimumab) in 50 to 60 patients with advance solid malignancies. The study is conducted by the MD Anderson Cancer Center in Houston, Texas, U.S..The primary aim of the study is to determine the best tolerable dose for lefitolimod in combination with Yervoy(R). The safety of this combination therapy will also be investigated and an expansion phase is planned to evaluate the efficacy of this combination therapy.

Results of the combination of EnanDIM(R) with checkpoint inhibitors in preclinical tumor models have been presented at the 2017 Clinical Immuno-Oncology Symposium (ASCO SITC) in Orlando, U.S. (23 - 25 February 2017).

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 immunotherapeutic agent lefitolimod is the company's lead product and best-in-class TLR9 agonist. Treatment with lefitolimod 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 can be recognized as an Immune Surveillance Reactivator (ISR). It has the potential to be applied to various indications. The 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 an extended phase I study in HIV and a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)). Next to checkpoint inhibitors, lefitolimod is one of the few product candidates that are in a phase III pivotal 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.

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)

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


Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
[email protected]

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.

27.02.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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