The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) will present pre-clinical data on its EnanDIMtechnology 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 EnanDIMfamily 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 EnanDIMcompounds and confirm immunomodulatory effects in vivo. These results allow the conclusion that EnanDIMISRs have the potential for clinical development in the treatment of cancer.
EnanDIM(Enantiomeric, DNA-based, ImmunoModulator)representsa 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 EnanDIMmolecules 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, EnanDIMmolecules 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 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 EnanDIMISRs promise a broad activation of the immune system with a good tolerability profile. Due to their characteristic mechanism of action, EnanDIMmolecules have the potentialto be applied in various cancer indications. Additionally, it may be possible to develop selected members of the EnanDIM 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 EnanDIMfamilymay also be used in the area of infectious diseases as HIV in the future.
"EnanDIM 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/2016-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
The Immune Surveillance Reactivator (ISR) EnanDIM (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 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(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, dSLIM, EnanDIM and MOLOGEN are registered trademarks of MOLOGEN AG.
Note about risk for future predictions
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Contacts:
MOLOGEN AG
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