BERLIN--(BUSINESS WIRE)--The biopharmaceutical company MOLOGEN AG has today published an initial data-based forecast for the expected date for the primary analysis of the pivotal IMPALA study. The study protocol of the IMPALA study foresees the conduct of the primary analysis when a prospectively defined amount of data on overall patient survival is available. Based on patient data collected up to April 2018 and using adequate statistical methodology, the time point for the primary analysis has now been predicted for April 2020. This statistical forecast involves a degree of uncertainty, reflected in the 95% confidence interval of plus/minus five months. This translates into a time window from year-end 2019 to summer 2020 in which the time point for the analysis will fall with a high probability. Hence, the now data-based prediction deviates only moderately from the previous forecast and enables a significantly higher degree of planning security regarding the time point for the read-out of the phase III study with the lead product candidate lefitolimod in colorectal cancer. It is planned, in due course, to repeat this type of analysis in order to review and, if necessary, adapt the current forecast.
Dr Matthias Baumann, Chief Medical Officer of MOLOGEN AG: “This state-of-the-art statistical analysis, based on actual patient data, which is available for the first time, will now allow us to reliably plan for the primary analysis of the IMPALA study, which is currently our most important and most advanced study with lefitolimod.”
Walter Miller, Chief Financial Officer of MOLOGEN AG: “The planning security that the analysis has provided for the IMPALA study is a hugely important aspect for our negotiations with potential partners as well as for any potential further rounds of funding.”
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 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 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 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®.
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®) 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 DE0006637200, SIN 663720) are listed in the Prime Standard of the German Stock Exchange.
Note about risk for future predictions
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