Regulatory authority gives green light for further development of an Alzheimer’s antibody
The Bavarian research company ISAR Bioscience is well on the way to a new Alzheimer’s therapy. This was the result of discussions with the responsible German regulatory authority, the Paul Ehrlich Institute (PEI). In a Scientific Advice Meeting, the PEI experts also gave a positive assessment of the development plan for the prompt and cost-effective production of the novel therapeutic compound. This is a therapeutic antibody with the provisional designation “M07”. Strengthened by the PEI vote, ISAR Bioscience can now take further steps towards clinical trials.
M07 is a fully human antibody with high binding affinity for a novel target structure found in certain cells of the brain. The antibody leads to a strong activation of the target structure and shows efficacy in a cell culture model of Alzheimer’s disease. The newly developed model consists of a combination of different brain cells differentiated from human induced pluripotent stem cells (hiPSC). The antibody protects the nerve cells from the damaging effects of amyloid-beta, which is considered to be the cause of Alzheimer’s dementia. The clear effect of the new antibody in the cell culture model is most likely due to its ability to activate the target structure.
A so-called master cell bank is required for the production of antibodies. The PEI had already advised the scientists at ISAR Bioscience on this topic at an earlier stage. ISAR Bioscience will now set up a specific master cell bank for the new antibody to enable its continuous production in accordance with the rules of good manufacturing practice (GMP). The Bavarian research company is currently conducting further preclinical studies and toxicology tests, after which clinical trials can begin.
ISAR Bioscience GmbH has been active in the development of new approaches to Alzheimer’s dementia for several years. The innovative company in Planegg near Munich specializes in the production of tailor-made therapies for degenerative and aims to bring medical research to application quickly.
