05.11.2018 - 08:40:56

MOLOGEN AG: Update on prediction of time point for availability of top-line data from the phase III IMPALA trial

Press Release N 24/2018 dated 11/05/2018

MOLOGEN: Update on prediction of time point for availability of top-line data from the phase III IMPALA trial

Berlin, 05 November 2018 - An updated prediction for the expected read out time point for the phase III IMPALA trial with the lead compound lefitolimod in metastatic colorectal cancer has been conducted on the basis of more mature patient data collected up to October 2018. This forecast now predicts the time frame for the availability of top-line data between summer and year-end 2019.

The increased maturity and size of the IMPALA patient data base at the time of the regular assessment by an independent data safety monitoring committee in October 2018 supported an educated update of the prediction for the expected read-out time point. Using state-of-the-art statistical methods and models, these analyses revealed a likely time frame for the availability of top-line data between summer and year-end 2019 including the necessary operational activities to prepare and close the data base as well as the actual statistical analysis. MOLOGEN will use this updated forecast to adapt and optimize its planning and operational activities to prepare for a smooth and timely process. Of course, also this current statistical forecast involves uncertainty, therefore this type of analysis may be repeated in due time for a potential adaptation.

In parallel to this forecast the same data basis served for a regular safety review by an independent expert committee, the data safety monitoring committee. In case of safety concerns for the trial population this independent committee would recommend adaptations, changes or even termination of the trial. The study protocol of the IMPALA study foresees such regular safety reviews to occur at least every six months. The conclusion of the October 2018 meeting of this group was again that the IMPALA study may continue as planned.

IMPALA is a pivotal, randomized, international, multicenter, open-label phase III trial. The study involves 549 patients from eight European countries, including the five major European pharmaceutical markets. Recruitment has been completed in May 2017. The study includes patients with metastatic colorectal cancer who have responded to standard first-line treatment. Lefitolimod is subsequently administered as maintenance therapy. The primary endpoint is overall survival and secondary study endpoints include progression-free survival, safety and tolerability, as well as Quality of Life (QoL).

The study is conducted in collaboration with three renowned national study groups: Arbeitsgemeinschaft Internistische Onkologie (AIO) in Germany, Grupo Español de Tratamiento de Tumores Digestivos (TTD) in Spain and Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) in France. The steering committee consists of internationally recognized medical experts including Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital, London, UK, as coordinating investigator.

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 extensive-stage small cell lung cancer (ES-SCLC) and the data from the extension phase of the TEACH study in HIV have been published. 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. ContactClaudia 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 predictionsCertain 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.


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Language: English Company: MOLOGEN AG Fabeckstraße 30 14195 Berlin

Germany Phone: 030 / 841788-0 Fax: 030 / 841788-50 E-mail: Internet: ISIN: DE000A2LQ900 WKN: A2LQ90 Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange   End of News DGAP News Service

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