DGAP-News: MOLOGEN presented final results from the randomized phase II IMPULSE study at ESMO 2018

PRESS RELEASE N 23/2018 of 22 October 2018

MOLOGEN presented final results from the randomized phase II IMPULSE study at ESMO 2018

Berlin, 22 October 2018 - The biopharmaceutical company MOLOGEN AG presented final data from the exploratory phase II IMPULSE study at the ESMO 2018 Congress (EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY) in Munich, Germany (19 - 23 October 2018). The randomized international study evaluated the efficacy and safety of lefitolimod in patients with extensive-stage small-cell lung cancer (ES-SCLC). The presented final IMPULSE data demonstrate that maintenance treatment of ES-SCLC with the TLR9 agonist lefitolimod showed a favorable safety profile, the expected immunological responses and positive results regarding overall survival (OS) in two pre-defined subgroups of patients. These data support further exploration of lefitolimod as single-agent or as combination therapy in ES-SCLC. Additionally to this presentation, these data are also being published in Annals of Oncology, the high-ranking, peer-reviewed journal of the European Society of Medical Oncology.

"Lung cancer and especially small-cell lung cancer is a very difficult-to-treat indication and the benefit of current standard treatment is very limited. Therefore the results of the IMPULSE study are encouraging and provide important guidance for defining patient subgroups that are most likely to benefit from our TLR9 agonist lefitolimod", said Dr Matthias Baumann, Chief Medical Officer of MOLOGEN. "The publication of the results in the high-ranking, peer-reviewed journal Annals of Oncology underlines the relevance of the data in the SCLC-field."

Promising OS results in pre-defined subgroups of IMPULSE
Two pre-defined patient subgroups indicated promising results, favoring lefitolimod with respect to OS. Notably, a strong overall survival (OS) signal was shown in comparison to the control arm (best standard of care) in patients with a low frequency of activated B cells (hazard ratio 0.53, 95% confidence interval 0.26-1.08), an important immune parameter. Furthermore, a benefit was seen in patients with reported chronic obstructive pulmonary disease (COPD) (hazard ratio 0.48, 95% confidence interval 0.20-1.17).
The present findings from IMPULSE provide additional key insights into the role of TLR9 agonists in the treatment of cancer, and confirm that there is a significant opportunity to improve outcomes for patients in this therapeutic area. The further development is currently being discussed with SCLC-experts.

Background to the IMPULSE extensive-stage small-cell lung cancer (ES-SCLC) study
The trial titled "Randomized Clinical Study of Maintenance Therapy with Immunomodulator MGN1703 in patients with Extensive Disease Small Cell Lung Cancer after Platinum-Based First-Line Therapy" (IMPULSE study) is an explorative study with OS l as the primary endpoint. It compares lefitolimod (MGN1703) versus local standard therapy. The study included 103 patients suffering from ES-SCLCS, and showing at least partial response to four cycles of first-line chemotherapy (n=103). They were randomized in a ratio of 3:2 to switch-maintenance therapy with lefitolimod (60mg injected subcutaneously twice weekly) or standard therapy until disease progression.

The full article published in Annals of Oncology is available: https://academic.oup.com/annonc/advance-article/doi/10.1093/annonc/mdy326/5076437

For more information on ESMO 2018 please visit the website: https://www.esmo.org

MOLOGEN AG
MOLOGEN AG is a biopharmaceutical Company and 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 focus of the development work is on the product family of DNA-based TLR9 agonists. This includes the lead compound lefitolimod and the next-generation molecule family EnanDIM^(R).

The immunotherapeutic agent lefitolimod is the Company's lead compound and is currently being investigated in a pivotal trial. It 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 mode of action, lefitolimod could potentially be used in various indications. 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, and the final analysis in the first quarter 2018 confirmed the data. Furthermore, data from the extension phase of the TEACH study in HIV have also been published in 2017. 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.

MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The shares (ISIN, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the German Stock Exchange.

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

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.