MOLOGEN AG, a biotechnology company focused on the development of cancer and infectious disease immunotherapies, has announced that its IMPULSE lung cancer clinical study has achieved its recruitment goal of 101 enrolled patients. The clinical trial, designed to evaluate the efficacy and safety of the drug MGN1703 in patients with small cell lung cancer (SCLC), is being conducted in collaboration with a network of lung cancer specialists in Germany, Aktion Bronchialkarzinom e.V.
Small cell lung cancer is a subtype of lung cancer characterized for its especially fast growing and spreading rates. When diagnosis is concluded, a large proportion of patients present with cancer that has usually spread and metastasized in other parts of the body. According to the American Cancer Society, SCLC accounts for 10% to 15% of all lung cancer cases. Oncology treatment usually includes chemotherapy, radiation therapy and surgery, but overall survival rates are very low with the current treatments available.
MGN1703 is a DNA-based molecule that activates the toll-like receptor (TLR) 9, a protein involved in the activation and stimulation of immune system cells that recognize and target the cancer cells. The targeting of TLR9 has been explored in research of therapies for a number of conditions such as treatment of allergy and against bacterial infections. Accordingly, MGN1703 is also being investigated in the IMPALA study as a new therapy for colorectal cancer and in an initial phase I study (TEACH) for HIV.
The IMPULSE trial, entitled “Randomized Clinical Study of Maintenance Therapy with Immunomodulator MGN1703 in patients with Extensive Disease Small Cell Lung Cancer after Platinum-Based First-Line Therapy” is set to compare MGN1703 to standard care, in patients that have received and responded to four cycles of chemotherapy. The primary endpoint of the study is overall survival and will use biomarkers to evaluate progress of treatment in each patient.
Dr. Matthias Schroff, CEO of MOLOGEN AG, commented on the recent success news in a press release, “Lung cancer and especially small cell lung cancer is a cancer indication for which the benefit of standard treatment is currently very limited. We are pleased that we finalized patient enrollment within the timeframe envisaged and we are very excited to learn about the effect of MGN1703 in this disease.”
The IMPULSE trial began in the end of March 2014 and MOLOGEN AG plans to start evaluating results in the end of 2016 and present its conclusions at the Annual Meeting of the American Society of Clinical Oncology 2017 (ASCO).