DGAP-News: MOLOGEN presented strong EnanDIM TME Data at AACR 2018

PRESS RELEASE N 8 / 2018 of 19/04/2018

MOLOGEN presented strong EnanDIM^(R) TME Data at AACR 2018

Berlin, 19 April 2018 - The biopharmaceutical company MOLOGEN AG presented data of its EnanDIM^(R) molecules, a new generation of potent non chemically-modified TLR9 agonists, at the AACR Annual Meeting 2018 (American Association for Cancer Research) in Chicago, Illinois, U.S. (14 - 18 April 2018). In murine tumor models, monotherapy with EnanDIM^(R) resulted^{in beneficial modulation of the tumor microenvironment (TME) translating into remarkable anti-tumor effects with highly increased survival rates. In two cancer models complete tumor regression in the majority of mice was observed. Importantly, in a subsequent re-challenge study all surviving mice rejected tumor cells, which indicates a sustained anti-tumor memory of the immune system. Hence, the data provide an excellent basis for further development of EnanDIM(R) in cancer.}

"The presented data clearly reveal the enormous potential of the EnanDIM^(R) product family. Hence, besides our late-stage candidate lefitolimod, we have strong follow-up molecules and we aim to enter EnanDIM^(R) into the clinical phase as soon as possible, of course depending on available resources", said Dr Mariola Soehngen, Chief Executive Officer of MOLOGEN.

"We are excited about the beneficial TME-modulating effects of single-agent EnanDIM^(R) which translated into remarkable anti-tumor activity, a clear pre-clinical proof of concept", said Dr Matthias Baumann, Chief Medical Officer at MOLOGEN, "and keep in mind that we have already promising pre-clinical results with EnanDIM^(R) and checkpoint inhibitors which have been presented last year. In summary, this is a clear "Go" for further development of EnanDIM^(R) in the IO space."

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 exhibiting an variable immunomodulatory pattern dependent on the specific EnanDIM^(R) molecule, a one-step production process.

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.

Latest data on the EnanDIM^(R) molecules have been presented not only at the AACR in Chicago, but also at the ITOC-5 Immunotherapy of Cancer Conference in Berlin (19 - 21 March 2018).

MOLOGEN AG
The focus of the development work is on the product family of DNA-based TLR9 agonists. This includes the lead product candidate lefitolimod and the next-generation molecule family EnanDIM^(R).

The immunotherapeutic agent lefitolimod is the company's lead product candidate and is currently being investigated in a pivotal trial. It is regarded as the best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. On account of this mode of action, lefitolimod could potentially be used in various indications. Lefitolimod is currently being developed within the framework of a pivotal study for first line maintenance therapy for colorectal cancer. Key data of the phase II IMPULSE study in small cell lung cancer have been announced in April 2017, and the final analysis in the first quarter 2018 confirmed the data. Furthermore, data from the extension phase of the TEACH study in HIV have also been published in 2017. In addition, lefitolimod is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy^(R)) in various cancer indications. Along with various checkpoint inhibitors, lefitolimod, which is being investigated as part of a phase III clinical trial currently, is one of the few near-to-market product candidates in the field of immuno-oncology.

MOLOGEN's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a great medical demand in particular.

MOLOGEN AG is a publicly listed company, headquartered in Berlin. The shares (ISIN DE0006637200, SIN 663720) are listed in the Prime Standard of the German Stock Exchange.
www.mologen.com

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.