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Mologen AG. (1/23/17). "Press Release: Combination Data of TLR9 Agonist Lefitolimod with Checkpoint Inhibitors in Preclinical Tumor Models".

Organisations Organisation Mologen AG
  Group Mologen (Group)
  Organisation 2 M. D. Anderson Cancer Center
  Group University of Texas System
Products Product lefitolimod (MGN1703)
  Product 2 Yervoy®
Persons Person Söhngen, Mariola (Convert Pharmaceuticals 201811– CEO before Mologen + Paion)
  Person 2 Nickolaus, Claudia (Mologen 201407– Head Investor Relations)

The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today first combination data of its TLR9 agonist lefitolimod with checkpoint inhibitors.

The data show that lefitolimod, a so-called Immune Surveillance Reactivator (ISR), can significantly improve the anti-tumor effect of checkpoint inhibitors, particularly anti-PD-1 and anti-PD-L1 antibodies, and thus prolong survival in murine tumor models. The beneficial effect of the combination of lefitolimod with anti-PD-1 compared to each monotherapeutic approach was confirmed in in-vitro experiments. All these results constitute a first preclinical confirmation of the combination approach of lefitolimod with checkpoint inhibitors in the treatment of cancer.

“We believe that patients can benefit from the combination of these immunotherapies due to their modes of action complementing each other. The new results are an important proof-of-concept for the combination approach of lefitolimod with checkpoint inhibitors. Consequently, the data open further application possibilities for our lead product, and support our ongoing phase I combination study of lefitolimod with the checkpoint inhibitor Yervoy® ”, said Dr. Mariola Söhngen, CEO of MOLOGEN AG.

The clinical combination study titled “A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients with Advanced Solid Malignancies” is conducted by MD Anderson Cancer Center (MD Anderson). MOLOGEN provides the Immune Surveillance Reactivator (ISR) lefitolimod and funds the study. Around 50-60 patients will participate in the MD Anderson Cancer Center study in Houston, Texas, U.S.. Patient recruitment began in July 2016 and is expected to be completed at the beginning of 2018.

The primary aim of the study is to determine the best tolerable dose for lefitolimod in combination with Yervoy®. The safety of this combination therapy will also be investigated and an expansion phase is planned to evaluate the efficacy of this combination therapy.

Results of the combination of lefitolimod with checkpoint inhibitors in preclinical tumor models have been presented at the Annual 2017 Gastrointestinal Cancers Symposium in San Francisco, USA (January 19-21, 2017).


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 immunotherapeutic agent lefitolimod is the company’s lead product and best-in-class TLR9 agonist. Treatment with lefitolimod 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 can be recognized as an Immune Surveillance Reactivator (ISR). It has the potential to be applied to various indications. The 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 an extended phase I study in HIV and a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy®). Next to checkpoint inhibitors, lefitolimod is one of the few product candidates that are in a phase III pivotal 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.

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)

MOLOGEN®, dSLIM®, EnanDIM® and MIDGE® are registered trademarks of MOLOGEN AG.


Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 – 38
Fax: +49 - 30 - 84 17 88 - 50

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.

Record changed: 2017-02-25


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