DGAP-News: MOLOGEN AG / Key word(s): Study
06.04.2018 / 09:28
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PRESS RELEASE N 6 / 2018 of 06/04/2018
MOLOGEN: Final analysis of IMPULSE study confirms topline data with positive subgroup results
Berlin, 6 April 2018 – The biopharmaceutical company MOLOGEN AG announced that the final evaluation of the randomized exploratory phase II IMPULSE study confirmed the findings presented in April 2017 and at the ESMO conference in September 2017. The study evaluated the efficacy and safety of lefitolimod in patients with extensive-stage small-cell lung cancer (ES-SCLC). Encouraging signals for beneficial effects on overall survival (OS) were observed in two predefined patient subgroups, although in the overall study population no relevant effect on OS could be shown. The Scientific Committee of the IMPULSE study and MOLOGEN are currently preparing a publication of the complete results in a recognized peer-reviewed journal. Furthermore, the Company is in discussions with clinical and scientific experts on a potential further development of lefitolimod in this highly challenging indication.
The final study analysis included 103 patients suffering from ES-SCLC whose tumors have responded to the standard first-line chemotherapy. IMPULSE showed encouraging signals for an OS benefit in two predefined subsets of patients: (1) In patients with a low number of activated B cells, an important immune parameter (hazard ratio 0.53, 95% confidence interval 0.26-1.08). (2) In patients with reported chronic obstructive pulmonary disease (COPD), a common underlying disease for lung cancer (hazard ratio 0.48, 95% confidence interval 0.20-1.17). Furthermore, the final analysis confirmed the favorable safety profile and the mode of action of lefitolimod.
“We are pleased that this final analysis confirmed the encouraging OS signals in two important subgroups of SCLC”, said Dr Matthias Baumann, CMO of MOLOGEN. “This provides us with guidance for a potential further development of lefitolimod in this exceptionally malignant illness in which practically no progress has been made over the past 30 years.”
The focus of the development work is on the product family of DNA-based TLR9 agonists. This includes the lead product candidate lefitolimod and the next-generation molecule family EnanDIM(R).
The immunotherapeutic agent lefitolimod is the company’s lead product candidate 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 DE0006637200, SIN 663720) are listed in the Prime Standard of the German Stock Exchange.
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