Date: 2014-03-24
Type of information: Clinical trial authorization
phase: 2-3
Announcement: clinical trial authorization
Company: Mologen (Germany)
Product: MGN1703 (lefitolimod)
Action
mechanism: immunotherapy product/TLR9 agonist. Lefitolimod (MGN1703) is based on dSLIM® (“double Stem Loop Immunomodulator”), a DNA-based TLR9 agonist developed by Mologen. dSLIM® activates the immune system against tumor-associated antigens by targeting various receptors on certain immune cells, primarily TLR9. Tumor-associated antigens (TAA) are released by cancer cells as a result of chemotherapy and radiation therapy. Once activated by dSLIM®, the immune system is able to overcome its fatal tolerance toward cancer cells and TAA and attacks them selectively. Treatment with lefitolimod (MGN1703) triggers a broad and strong activation of the immune system. Due to this mechanism of action, lefitolimod (MGN1703) has the potential to be applied to various indications.
Disease: small cell lung cancer
Therapeutic area: Cancer - Oncology
Country: Austria, Belgium, Germany
Trial
details: The trial with the title “Randomized Clinical Study of Maintenance Therapy with Immunomodulator MGN1703 in patients with Extensive Disease Small Cell Lung Cancer after Platinum-Based First-Line Therapy” (IMPULSE study) will determine overall survival as primary endpoint. The trial will compare MGN1703 versus best standard of care. The study will include patients who are suffering from an extensive disease stage of small cell lung cancer (SCLC) and whose tumors have responded after four cycles of standard first line therapy with chemotherapeutics. It is planned to screen approximately 110 patients in order to enroll 100 patients in the study. Eligible patients randomized to the experimental arm will receive treatment with MGN1703 until renewed progression of the cancer disease. Coordinating investigator is Prof. Dr. med. Michael Thomas, oncologist and Head of the Thoracic Oncology Department in the Thorax Clinic at the University Clinic Heidelberg. In Germany, the study will be conducted in collaboration with the „Aktion Bronchialkarzinom e.V.“ (ABC group) – a renowned German oncologists network of lung cancer specialists.
Latest
news: * On March 24, 2014, Mologen has announced it has obtained the approvals for the IMPULSE lung cancer study from the competent authority and the responsible ethics committee in Belgium. The trial has now been started and is open for recruitment. A first patient has signed the informed consent and is currently being screened. With this study Mologen aims to expand the potential application of the cancer immune therapy MGN1703 by a further indication. The study protocol has also been submitted to the authorities and ethics committees in Austria and Germany. The approvals in these countries have not been obtained yet but are expected during the second quarter.
* On October 28, 2013, Mologen has announced it has submitted a clinical trial application with MGN1703 in small-cell lung cancer to the competent authority in Belgium. The trial application will also be submitted shortly to the authorities in Germany and Austria as well as to the responsible ethics committees.
* On October 10, 2013, Mologen has announced it has completed the planning for a clinical trial with MGN1703 in small-cell lung cancer. The trial application shall shortly be submitted to the competent authorities and ethics committees in Germany, Austria and Belgium. The study is designed as an open-label, two-arms, randomized and multi-center study. The aim of the study is to evaluate the efficacy and safety of MGN1703. Primary endpoint is overall survival. This trial will replace the trial application submitted in 2012.
