Dutch biotechnology company Mucosis BV today announced the start of a Phase 1 clinical study with its lead product FluGEM, a novel improved influenza vaccine for the elderly. It is the first-ever study in man with a vaccine candidate based on Mimopath, a proprietary platform technology for developing more potent vaccines.
The clinical study will be conducted in conjunction with the Centre for Human Drug Research (CHDR, Leiden, the Netherlands). It is designed to test the safety and tolerability of FluGEM, as well as the mucosal and systemic immune responses including correlates of protection against influenza viruses. The trial will involve FluGEM being administered both as droplets in the nose and by intramuscular injection.
Mucosis has evaluated FluGEM for safety and toxicity in well-accepted animal models, and found it to be safe at all doses tested. Moreover, preclinical results show an induction of robust mucosal and systemic immunity and superior protection from an influenza challenge.
“We are very pleased with the on-schedule initiation of this Phase 1 study,” said Govert Schouten, CEO of Mucosis. “This is an important step towards realizing our ambition of taking an improved flu vaccine to the market. In addition, this study will validate Mimopath as a platform technology for the development of new vaccines that provide better and broader protection”.
The enrollment of volunteers for the trial has been initiated and immunizations are scheduled to start in the next weeks. The vaccine will be tested in 90 adult and 60 elderly trialists. Interim top-line data from the study are expected to become available before the end of 2011. The clinical study is financially supported by Agentschap NL, an agency of the Dutch Ministry of Economic Affairs, Agriculture and Innovation.
The Mimopath technology is based on Lactococcus lactis, a safe bacterium commonly used in the food industry. Mucosis has developed a robust technique to formulate the L. lactis bacteria into non-living bacterial-like particles (BLPs) that can be loaded with antigens from viral, bacterial, parasitic or tumor origin. The antigen-covered BLPs form a vaccine that can be delivered into the nose or mouth, without the need for a needle. These vaccines raise protective immunity by activation of both the innate and the adaptive immune system.