Mologen AG Presents EnanDIM: A New Generation Of Immunomodulators
New generation of linear TLR-9 agonists
? EnanDIM induces broad immune activation
? Potential application in the fields of cancer and anti-infective therapies
? Preclinical data presented for the first time on conference in San Diego
Berlin, October 14, 2014 – MOLOGEN has presented preclinical data on its EnanDIM technology at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) in San Diego, United States. EnanDIM represents a new generation of the company’s immunoactivating TLR-9 agonists that is expected to trigger a broad immune activation while being well tolerated. Potential applications include the fields of anti-tumor and anti-infective therapies.
DNA-based TLR-9 agonists are potent activators of the innate immune system and of a variety of immune cell populations. So far, two different types of TLR-9 agonists have been established. The first consists of linear, single-stranded DNA molecules. Most of these linear TLR-9 agonists are chemically modified to protect them against degradation, which is known to produce off-target effects and toxicity. MOLOGEN’s lead product, the cancer immunotherapy MGN1703, represents the second type of TLR-9 agonist, a covalently-closed, dumbbell-shaped DNA molecule. As it consists entirely of natural DNA components, it is safe and well tolerated.
EnanDIM® (Enantiomeric, DNA-based, ImmunoModulator), the new class of linear TLR-9 agonists, combines the immunoactivatory properties of molecules containing only natural DNA components with the advantages of linear molecules. Despite its linear structure, no chemical modifications are needed as the specific linear structure of EnanDIM protects the molecules against degradation. This protection is achieved by incorporation of mirror-imaged components, which are chemically identical to the naturally occurring DNA components but that are not recognized by DNA-degrading enzymes. Consequently, a favorable safety and tolerability profile is expected to be shown in the planned subsequent preclinical and clinical development.
The broad immune activation induced by EnanDIM in preclinical models has been presented at OTS in an oral presentation. Therefore, the mode of action should enable the use 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. Furthermore, it could potentially be used in the field of infectious diseases.
Dr. Matthias Schroff, CEO of MOLOGEN AG, commented: “We are very pleased about the positive feedback at the OTS meeting. EnanDIM is expected to have a safety and tolerability profile in clinical tests comparable to the profile of our lead product MGN1703. Based on its broad immune activation potential EnanDIM may be used in a variety of indications including cancer immunotherapy. This again shows our innovative capacity and expertise in the field of immune therapies and in immuno oncology in particular.”
Detailed information on EnanDIM, as discussed at the oral presentation, is summarized in the poster with the title “EnanDIM: A new class of enantiomeric oligodeoxynucleotides for TLR-9 activation” (poster no. 056). For more information please visit the OTS website www.oligotherapeutics.org.
MOLOGEN’s proprietary TLR-9 agonist and cancer immune therapy MGN1703 is currently being investigated in the phase III clinical trial IMPALA for first-line maintenance treatment of metastatic colorectal cancer. The trial is being conducted in eight European countries, including the five major pharma markets.
Furthermore, MGN1703 is being investigated for first-line maintenance treatment of extensive-stage small cell lung cancer, a serious cancer disease with high unmet medical need. IMPULSE, an international randomized controlled trial, is currently enrolling patients as well.
For more information of the IMPALA and IMPULSE trials, visit www.clinicaltrials.gov.
About EnanDIM®
EnanDIM® (Enantiomeric, DNA-based, ImmunoModulator) is an innovative linear DNA-based TLR-9 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 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.
About MOLOGEN AG
MOLOGEN AG is a biotechnology company specialized in the research and clinical development of cancer immune therapies and DNA vaccines against infectious diseases.
The cancer immune therapy MGN1703 is the company’s lead product and best-in-class TLR-9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial) and lung cancer (randomized controlled trial). A second clinical-stage product is MGN1601, a therapeutic vaccination for the treatment of renal cancer. A phase I/II clinical study has already been completed successfully.
With unique, patented technologies and innovative products, MOLOGEN is pioneering immune therapies. MOLOGEN AG is a publicly listed company, headquartered in Berlin. The shares (ISIN DE0006637200) are listed in the Prime Standard of the German Stock Exchange.
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.
MOLOGEN AG
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 – 86
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
Help employers find you! Check out all the jobs and post your resume.
? EnanDIM induces broad immune activation
? Potential application in the fields of cancer and anti-infective therapies
? Preclinical data presented for the first time on conference in San Diego
Berlin, October 14, 2014 – MOLOGEN has presented preclinical data on its EnanDIM technology at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) in San Diego, United States. EnanDIM represents a new generation of the company’s immunoactivating TLR-9 agonists that is expected to trigger a broad immune activation while being well tolerated. Potential applications include the fields of anti-tumor and anti-infective therapies.
DNA-based TLR-9 agonists are potent activators of the innate immune system and of a variety of immune cell populations. So far, two different types of TLR-9 agonists have been established. The first consists of linear, single-stranded DNA molecules. Most of these linear TLR-9 agonists are chemically modified to protect them against degradation, which is known to produce off-target effects and toxicity. MOLOGEN’s lead product, the cancer immunotherapy MGN1703, represents the second type of TLR-9 agonist, a covalently-closed, dumbbell-shaped DNA molecule. As it consists entirely of natural DNA components, it is safe and well tolerated.
EnanDIM® (Enantiomeric, DNA-based, ImmunoModulator), the new class of linear TLR-9 agonists, combines the immunoactivatory properties of molecules containing only natural DNA components with the advantages of linear molecules. Despite its linear structure, no chemical modifications are needed as the specific linear structure of EnanDIM protects the molecules against degradation. This protection is achieved by incorporation of mirror-imaged components, which are chemically identical to the naturally occurring DNA components but that are not recognized by DNA-degrading enzymes. Consequently, a favorable safety and tolerability profile is expected to be shown in the planned subsequent preclinical and clinical development.
The broad immune activation induced by EnanDIM in preclinical models has been presented at OTS in an oral presentation. Therefore, the mode of action should enable the use 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. Furthermore, it could potentially be used in the field of infectious diseases.
Dr. Matthias Schroff, CEO of MOLOGEN AG, commented: “We are very pleased about the positive feedback at the OTS meeting. EnanDIM is expected to have a safety and tolerability profile in clinical tests comparable to the profile of our lead product MGN1703. Based on its broad immune activation potential EnanDIM may be used in a variety of indications including cancer immunotherapy. This again shows our innovative capacity and expertise in the field of immune therapies and in immuno oncology in particular.”
Detailed information on EnanDIM, as discussed at the oral presentation, is summarized in the poster with the title “EnanDIM: A new class of enantiomeric oligodeoxynucleotides for TLR-9 activation” (poster no. 056). For more information please visit the OTS website www.oligotherapeutics.org.
MOLOGEN’s proprietary TLR-9 agonist and cancer immune therapy MGN1703 is currently being investigated in the phase III clinical trial IMPALA for first-line maintenance treatment of metastatic colorectal cancer. The trial is being conducted in eight European countries, including the five major pharma markets.
Furthermore, MGN1703 is being investigated for first-line maintenance treatment of extensive-stage small cell lung cancer, a serious cancer disease with high unmet medical need. IMPULSE, an international randomized controlled trial, is currently enrolling patients as well.
For more information of the IMPALA and IMPULSE trials, visit www.clinicaltrials.gov.
About EnanDIM®
EnanDIM® (Enantiomeric, DNA-based, ImmunoModulator) is an innovative linear DNA-based TLR-9 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 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.
About MOLOGEN AG
MOLOGEN AG is a biotechnology company specialized in the research and clinical development of cancer immune therapies and DNA vaccines against infectious diseases.
The cancer immune therapy MGN1703 is the company’s lead product and best-in-class TLR-9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial) and lung cancer (randomized controlled trial). A second clinical-stage product is MGN1601, a therapeutic vaccination for the treatment of renal cancer. A phase I/II clinical study has already been completed successfully.
With unique, patented technologies and innovative products, MOLOGEN is pioneering immune therapies. MOLOGEN AG is a publicly listed company, headquartered in Berlin. The shares (ISIN DE0006637200) are listed in the Prime Standard of the German Stock Exchange.
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.
MOLOGEN AG
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 – 86
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
Help employers find you! Check out all the jobs and post your resume.