MOLOGEN AG: Recruitment goal achieved for the pivotal IMPALA study with lefitolimod in colorectal cancer patients

The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) has achieved the recruitment goal with the inclusion of currently 540 patients for the pivotal IMPALA study in metastatic colorectal cancer “mCRC”. The aim of this study is to show that a switch maintenance therapy with the immunotherapeutic agent lefitolimod can lead to a prolongation of overall survival in patients with mCRC. With the finalization of recruitment, the company reached the next important milestone in the clinical study program of its lead product lefitolimod.

“We are pleased that the enrollment for IMPALA has been completed and that treatment with lefitolimod is so far well tolerated”, said Dr. Matthias Baumann, Chief Medical Officer of MOLOGEN AG. “This is an important milestone for us as the pivotal IMPALA study is by far the largest study for us to date. We look forward to the study results in this high medical need indication, which will be available, once sufficient survival data have been collected. This is currently expected in 2019, which of course depends on the actual overall survival rates.

Approximately 540 patients from more than 120 centers in eight European countries, including the five most important European pharmaceutical markets, participate in the study. The study will be evaluated once a certain number of deaths (events) have occurred, which is currently estimated to be reached around two years after completion of patient enrollment. MOLOGEN is continuously and closely monitoring the events and the corresponding timeline for the results.

Colorectal cancer

Colorectal cancer is one of the most common cancers worldwide with 1,361,000 cases in 2012. In the same year it accounted for approximately 694,000 deaths worldwide. In the US 134,000 cases have occurred in 2012, and 55,000 people have died from this disease.

About IMPALA

IMPALA (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with tumor reduction during induction treatment) is a pivotal, randomized, international, multicenter, open-label phase III trial. The study aims to prove that a switch maintenance therapy with an active immunotherapy with lefitolimod leads to an increased overall survival of patients who have achieved a response during their first line treatment of metastatic colorectal cancer. 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 Españiol 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

As a biopharmaceutical company, MOLOGEN AG is considered a pioneer in the field of immunotherapies on account of its unique compounds and technologies. Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapeutic agents for the treatment of infectious diseases.

The immunotherapeutic agent lefitolimod is the company’s lead product and 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 is an immune surveillance reactivator (ISR) and has the potential to be used in a variety of different indications. At present, the ISR lefitolimod is being developed for first-line maintenance treatment of metastatic colorectal cancer (pivotal study). The phase II IMPULSE study in small-cell lung cancer (SCLC) shows positive results in two pre-defined and clinically relevant subgroups of patients. A more extensive evaluation of the IMPULSE data is currently ongoing. In addition, the ISR lefitolimod is currently being investigated in an extended phase I trial in HIV and a phase I combination study with the checkpoint inhibitor Yervoy® (ipilimumab). Alongside checkpoint inhibitors, lefitolimod is one of the few product candidates in the field of immuno-oncology that is close to market. MOLOGEN’s pipeline focuses on new innovative immunotherapies to treat diseases for which there is great medical demand.

For more information on the trials please visit www.clinicaltrials.gov.

www.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 updating such information, which only represents the state of affairs on the day of publication.

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