DGAP-News: MOLOGEN AG: Next generation TLR9 agonist product family EnanDIM(R) featured in renowned JITC journal

PRESS RELEASE N 2 / 2019 of 01/18/2019

MOLOGEN AG: Next generation TLR9 agonist product family EnanDIM^(R) featured in renowned JITC journal

Berlin, 18 January 2019 - The biopharmaceutical company MOLOGEN AG reported that its scientific article on EnanDIM^(R), MOLOGEN's novel family of TLR9 agonists for immunotherapeutic approaches, has been published in the high-ranking, peer-reviewed Journal for ImmunoTherapy of Cancer (JITC) - the journal of the Society for Immunotherapy of Cancer (SITC).

The article is featuring the development of the EnanDIM^(R) product family including its innovative design and the identification of potent family members for cancer immunotherapy. EnanDIM^(R) comprises a range of TLR9 agonists that facilitate an efficacious activation of both innate and adaptive immunity. Their proven potential in immuno-oncology, as shown by cytotoxic activity, beneficial modulation of the tumor microenvironment, inhibition of tumor growth, and induction of long-lasting, tumor-specific memory, supports EnanDIM^(R) molecules for further preclinical and clinical development.

"This publication in the prestigious JITC journal impressively underscores the interest of the international scientific community in our novel compound family EnanDIM^(R) with its broad potential", said Dr Matthias Baumann, CMO of MOLOGEN AG. "With EnanDIM^(R) we have, besides our late-stage candidate lefitolimod, a strong and versatile pipeline of follow-up molecules with diverse characteristics and applications also beyond immuno-oncology. Consequently, we strive to enter the first candidate into the clinical phase as soon as possible."

The full article published in Journal for ImmunoTherapy of Cancer is available: https://jitc.biomedcentral.com/articles/10.1186/s40425-018-0470-3
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 MOLOGEN's follow-up compounds to lefitolimod exhibiting an variable 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. 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. 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
MOLOGEN AG is a biopharmaceutical Company and a pioneer in the field of immunotherapy on account of its unique active agents and technologies. Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapies for the treatment of infectious diseases.
The focus of the development work is on the product family of DNA-based TLR9 agonists. This includes the lead compound lefitolimod and the next-generation molecule family EnanDIM^(R).

The immunotherapeutic agent lefitolimod is the Company's lead compound 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 extensive-stage small cell lung cancer (ES-SCLC) and the data from the extension phase of the TEACH study in HIV have been published. 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, DE000A2LQ900/SIN: A2L Q90) 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

Disclaimer
Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.