MOLOGEN Presents First Anti-tumor Data of Product Candidate

BERLIN–(BUSINESS WIRE)–The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock
Exchange Prime Standard: MGN) announced today first preliminary data on
its EnanDIM^® technology in a murine tumor
model. EnanDIM^® is a new family of TLR9
agonists and so-called Immune Surveillance Reactivators (ISR). The
pre-clinical in vivo data shows that EnanDIM^®
can reduce tumor growth and thus prolong survival. It has been shown
previously that EnanDIM^® 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^® in the treatment of cancer.
“This is the next important step for our promising new generation TLR9
agonist EnanDIM^®. For the first time we observed reduced
tumor growth in a murine model. These results strongly support the
pre-clinical development of our EnanDIM^® 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^®.
EnanDIM^® (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^®
molecule.
The EnanDIM^® 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^®
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^® ISR promise a broad activation of the immune
system with a good safety and tolerability profile. Due to their
characteristic mechanism of action, EnanDIM^® molecules have
the potential to 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 EnanDIM^®
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: https://www.aacr.org.
About EnanDIM^®
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 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^®
(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®, dSLIM®, EnanDIM® and MOLOGEN® are registered trademarks of
MOLOGEN AG.
Note about risk for future predictions
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