DGAP-News: MOLOGEN presents first anti-tumor data of the

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. --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- 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 --------------------------------------------------------------------------- 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 --------------------------------------------------------------------------- 500731 12.09.2016