PRESS RELEASE N 21 / 2017 of 11/12/2017
Poster Presentations on lefitolimod and EnanDIM(R) at
ESMO IO 2017
Berlin, 11 December 2017 - The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) presented two posters at the ESMO IO 2017 (European Society for Medical Oncology - Immuno Oncology) in Geneva, Switzerland (7 - 10 December 2017). The first poster featured data on patient characteristics from the pivotal IMPALA study in metastatic colorectal cancer (mCRC) evaluating the lead product candidate lefitolimod. IMPALA includes a representative mCRC patient group - a prerequisite to guide standard maintenance therapy in future. A second poster showed the impact of the EnanDIM(R) family of TLR9 agonists on the tumor microenvironment (TME) in murine models and the anti-tumor effect in combination with immune checkpoint inhibitors.
"We are delighted that the presentation on IMPALA has been well received and that our Steering Committee considers the maintenance treatment scheme with lefitolimod to have practice-changing potential - provided the outcome of IMPALA will be positive. In other words, lefitolimod could potentially be a safe and efficacious maintenance treatment after successful first line therapy. This would place MOLOGEN in a very attractive position in the CRC market - even in the light of other novel immune-oncology approaches", said Dr Matthias Baumann, CMO of MOLOGEN AG.
IMPALA: Representative mCRC study population
Based on the findings of MOLOGEN's phase II IMPACT study, IMPALA aims to prove that a switch maintenance therapy with an active immunotherapy leads to an increased overall survival of patients who have achieved a response during their first line treatment of metastatic colorectal cancer. This is reflected in the study design of the pivotal IMPALA trial where 'objective response to induction therapy' is one of the main inclusion criteria. The recruitment of the study has been completed in May 2017. MOLOGEN presented selected baseline characteristics of the 549 enrolled patients with the conclusion that the overall study population represents 'typical' mCRC patients. Furthermore, distribution of demographic parameters such as gender and age was balanced over both treatment arms.
EnanDIM(R): High potential as single agent or in combination in immuno-oncology
The EnanDIM(R)-induced TLR9 pathway provides the rationale for combining EnanDIM(R) with checkpoint inhibitors (CPI). The presented data showed that monotherapy with EnanDIM(R) resulted in a modulation of the TME in a murine colon carcinoma tumor model after intra-tumoral injection. An increased infiltration of T cells, especially cytotoxic T cells, into the tumor was shown, which was associated with reduced tumor growth. In addition, EnanDIM(R) significantly improved the anti-tumor effect of a CPI (anti-PD-1), and thus prolonged survival in murine colon carcinoma tumor model.
These data clearly support EnanDIM(R)'s potential in cancer immunotherapy, both as single agent and in combination with other immuno-oncology approaches.
Dr Mariola Söhngen, CEO of MOLOGEN AG: "We believe that patients can benefit from the combination of these immunotherapeutic approaches due to the fact that their modes of action complement each other. The EnanDIM(R) molecules initiate a broad activation of the innate and adaptive immune system and may achieve the conversion of "cold" into "hot" tumors which is a prerequisite for a response to checkpoint inhibitors."
The EnanDIM(R) (Enantiomeric, DNA-based, ImmunoModulator) family, as a new generation of immunomodulators and so called Immune Surveillance Reactivators (ISR), belongs to the class of TLR9 agonists and represents one of MOLOGEN's follow-up compounds to its lead compound lefitolimod.
The EnanDIM(R) molecules consist entirely of natural DNA, as is also the case with lefitolimod. The main difference between MOLOGEN's two ISR families is their molecule structure. Whereas lefitolimod is dumbbell-shaped and covalently-closed, EnanDIM(R) molecules have a linear structure. However, as with lefitolimod, due to its specific structure, no chemical modification is needed in order to protect the molecules against degradation by enzymes. The EnanDIM(R) molecules initiate a broad activation of the innate and adaptive immune system. The conversion of non-immunogenic ("cold") tumors into immunogenic ("hot") tumors, characterized by their T cell infiltration, is a prerequisite for a response to checkpoint inhibitors.
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). 549 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, approx. 2019.
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.
For more information on the trials IMPACT and IMPALA please visit www.clinicaltrials.gov.
For more information on ESMO IO 2017 please visit the website
MOLOGEN AG is a biopharmaceutical company and considered 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 immunotherapy lefitolimod (MGN1703) is the company's lead product and 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 action mechanism, lefitolimod is an immune surveillance reactivator (ISR) and could potentially be used in various indications. The ISR 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. Detailed analyses of IMPULSE data and data from the extension phase of the TEACH study in HIV, published in August, are currently being conducted. 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.
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