DGAP-News: MOLOGEN AG

PRESS RELEASE N 1 / 2018 of 22/01/2018

MOLOGEN presented lefitolimod TME data at ASCO GI 2018

Berlin, 22 January 2018 - The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) presented data on its lead compound, the TLR9 agonist and immune surveillance reactivator lefitolimod, at the Annual 2018 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco (18 - 20 January 2018). Monotherapy with lefitolimod resulted in a beneficial modulation of the tumor microenvironment (TME) associated with a reduced tumor growth in a murine model of colorectal cancer. The beneficial lefitolimod-induced modulation of the TME strongly supports its potential as cancer immunotherapeutic agent. Hence, in addition to its potential in monotherapy, lefitolimod may also be an ideal partner for immuno-oncology combination approaches, i.e. with checkpoint inhibitors.

"Beneficial modulation of the TME, in other words making immunologically "cold" tumors "hot", is a crucial requirement for the response to immunotherapeutic approaches. The presented data clearly support the mode-of-action of lefitolimod in our late-stage IMPALA study with single-agent lefitolimod in colorectal cancer. In addition they provide an excellent rationale for combining lefitolimod with checkpoint inhibitors. We know that checkpoint inhibitors need help to fully unfold their enormous potential and we believe that our TLR9 agonist lefitolimod will play a major role also in this context", said Dr Matthias Baumann, CMO of MOLOGEN AG.

Beneficial lefitolimod-induced modulation of the TME

After intratumoral injection of lefitolimod an increased infiltration of T cells (CD3+ T cells, especially CD8+ T cells) into the tumor was observed. Furthermore, also an increase of activated CD8+ T cells with cytolytic ("cell destruction capability") potential was determined. In addition, the injection of lefitolimod had a positive impact regarding so-called tumor-associated macrophages - immune cells that interact with tumor cells to influence the initiation, growth and metastasis of tumors. Lefitolimod led to an increase of anti-tumor M1-type macrophages within the tumor, accompanied with a decrease of pro-tumorigenic M2-type macrophages.
Importantly, this beneficial TME modulation from an immunosuppressed ("cold") towards a more immunoreactive ("hot") stage translated into a reduction of tumor growth in the mice.

Lefitolimod as a partner for immuno-oncological combination therapies

The lefitolimod-induced pathway provides the rationale for combining lefitolimod with checkpoint inhibitors. Response rates to checkpoint inhibitor immunotherapy vary between different tumor entities and depend on the nature of the TME. "Hot" tumors with a T cell infiltrated TME show better responses. Therefore modulation of the TME is a crucial requirement for the response to immunotherapeutic approaches.
First combination data of lefitolimod with checkpoint inhibitors have been presented at the ASCO GI 2017. The data showed that lefitolimod 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.

For more information on ASCO GI please visit the website:
https://gicasym.org/

MOLOGEN AG
MOLOGEN AG is a biopharmaceutical company and considered a pioneer in the field of immunotherapy on account of its unique active agents and technologies. Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapies for the treatment of infectious diseases.
The immunotherapy lefitolimod (MGN1703) is the company's lead product and is regarded as the best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. On account of this action mechanism, lefitolimod is an immune surveillance reactivator (ISR) and could potentially be used in various indications. The ISR lefitolimod is currently being developed within the framework of a pivotal study for first line maintenance therapy for colorectal cancer. Key data of the phase II IMPULSE study in small cell lung cancer have been announced in April 2017. Detailed analyses of IMPULSE data and data from the extension phase of the TEACH study in HIV, published in August, are currently being conducted. In addition, lefitolimod is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy^(R)) in various cancer indications. Along with various checkpoint inhibitors, lefitolimod, which is being investigated as part of a phase III clinical trial currently, is one of the few near-to-market product candidates in the field of immuno-oncology.

MOLOGEN's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a great medical demand in particular.
www.mologen.com

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

Disclaimer
Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.