Reg­u­lat­ory author­ity gives green light for fur­ther devel­op­ment of an Alzheimer’s antibody

© Chris­toph Burgstedt - iStock

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.