MOLOGEN AG
MOLOGEN AG: First patient recruited in combination study with lefitolimod and Yervoy(R)
DGAP-News: MOLOGEN AG / Key word(s): Study PRESS RELEASE N 12 / 2016 of 07/13/2016 MOLOGEN AG: First patient recruited in combination study with lefitolimod and Yervoy(R) – Collaboration with MD Anderson Cancer Center, US – Phase I study to evaluate combination of ISR lefitolimod (MGN1703) and checkpoint inhibitor Yervoy(R) – Combination of immunotherapies could lead to a broader activation of the immune system Berlin, 13 July 2016 – The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today that its collaborator, the University of Texas MD Anderson Cancer Center (MD Anderson), has enrolled the first patient in the combination study (FPI: first patient in) with a checkpoint inhibitor. In the phase I study MOLOGEN’s TLR9 agonist, the Immune Surveillance Reactivator (ISR) lefitolimod (MGN1703) is tested in combination with the immunotherapy ipilimumab (Yervoy(R)) in patients with advanced solid malignancies. The collaboration has been initiated in January 2016 based on the idea that the combination of these two immunotherapies could have synergistic effects leading to a broader activation of the immune system. MD Anderson is conducting the trial and will recruit around 50-60 patients at its center in Houston Texas, US. MOLOGEN is providing the ISR lefitolimod (MGN1703). Patient recruitment is expected to be completed at the beginning of 2018. This will be the first time ISR lefitolimod is evaluated in combination with a checkpoint inhibitor. The aim of the combination study is to initially find the highest tolerable dose of lefitolimod (MGN1703) that can be given in combination with ipilimumab (Yervoy(R)) to patients with advanced tumors. The safety of this drug combination will also be analyzed. Furthermore, this trial aims to evaluate the efficacy of the combination of these two therapies in an expansion phase. Lefitolimod (MGN1703) is a TLR9 agonist that by broadly activating immune surveillance can trigger the body’s own cancer-fighting mechanisms. “We are very pleased by the start of this combination study. It will be exciting to learn more about this combination therapy given the positive findings in pre-clinical models”, said Dr. David S. Hong, Deputy Chair and Associate Professor, Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center, and principal investigator of the study. “To treat the first patient is an important milestone. We hope to show that the combination of Yervoy(R) with lefitolimod will demonstrate improved therapeutic responses compared to the use of either monotherapy alone. We also strongly believe that the combination of different immunotherapies will be of benefit in a number of patients. If successful, we could substantially broaden the potential applications of lefitolimod”, said Dr. Mariola Söhngen, CEO of MOLOGEN. About the combination study lefitolimod (MGN1703) with the checkpoint inhibitor Yervoy(R) The primary aim of the study is to ascertain the best tolerable dosage for administering lefitolimod (MGN1703) in combination with Yervoy(R). The safety of this combination therapy will also be investigated and an expansion phase is planned to evaluate the efficacy of this combination therapy. MOLOGEN AG The cancer immunotherapy lefitolimod (MGN1703) is the company’s lead product and best-in-class TLR9 agonist. Treatment with lefitolimod (MGN1703) triggers a broad and strong activation of the immune system. Due to this mode of action, namely to reactivate the monitoring function of the immune system, lefitolimod (MGN1703) can be recognized as an Immune Surveillance Reactivator (ISR). It has the potential to be applied to various indications. ISR lefitolimod (MGN1703) is currently being developed for first-line maintenance treatment of colorectal cancer (pivotal study) and small cell lung cancer (randomized controlled trial). Furthermore, it is also being investigated in an extended phase I study in HIV and a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)). Next to checkpoint inhibitors, lefitolimod is one of the few product candidates that are in a phase III clinical trial (IMPALA) in the field of immuno-oncology and close to reaching the market. MOLOGEN’s pipeline focus is on new, innovative immunotherapies to treat diseases for which there is a high medical need. Memberships in associations: MIDGE(R), dSLIM(R), EnanDIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG. Contact Note about risk for future predictions
2016-07-13 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |
Language: | English | |
Company: | MOLOGEN AG | |
Fabeckstraße 30 | ||
14195 Berlin | ||
Germany | ||
Phone: | 030 / 841788-0 | |
Fax: | 030 / 841788-50 | |
E-mail: | presse@mologen.com | |
Internet: | www.mologen.com | |
ISIN: | DE0006637200 | |
WKN: | 663720 | |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart | |
End of News | DGAP News Service |