CureVac GmbH announced that the Paul-Ehrlich-Institute, the German regulatory authority for medicinal products, has approved the Clinical Trial Application (CTA) to begin a Phase I clinical study with RNActive® derived mRNA vaccine CV9201. The vaccine will be tested in patients with advanced non-small cell lung cancer who have been pre-treated with different therapies.
CV9201 is the second active immunotherapeutic agent in CureVac’s vaccine pipeline of RNActive® derived molecules for active immunotherapy of cancer. The vaccine comprises modified mRNA components coding for five different antigens frequently expressed by non-small cell lung cancer cells. Three of these antigens (NY-ESO-1, MAGE-C1/CT7 and MAGE-C2/CT10) are in-licensed from the Ludwig Institute for Cancer Research (LICR), New York, U.S.A. The Phase I study is designed to assess the safety and tolerability of CV9201 that will be administered directly into the skin. The multicentre study will be conducted in Switzerland and Germany at five different sites. CureVac expects preliminary results to be available in the second half of 2011.“After approval to begin studies for our lead therapy CV9103 to treat hormonerefractory metastatic prostate cancer in the EU and US; CV9201 is now the second product within our mRNA-based vaccine portfolio entering Phase I clinical studies,” commented Thomas Lander, M.D., Managing Director of CureVac. “The preclinical data for CV9201 shows great promise that the vaccine will trigger a strong immune response in turn producing antigen-specific T-lymphocytes that have the ability to attack the tumour. At this stage of development we are ensuring this immunotherapy is well tolerated and safe in humans and provides a significant immune response.”