Under terms of the deal, contract manufacturing organisation (CMO) Rentschler is charged with developing PBD-C06 - Probiodrug’s pGlu-Abeta-specific monoclonal antibody – from cell line development to preclinical and clinical biomanufacturing.
“Rentschler is a well-known and renowned CMO with a proven track record of over 40 years. They already have the required processes in place,” Probiodrug’s CEO Konrad Glund told this publication.
He added Rentschler had been selected from a number of CMOs and “met the specifications and criteria required for this project. Their experience and track record were notable and they are committed to meeting our aggressive timelines.”
The candidate itself is a chimeric, de-immunized monoclonal antibody being investigated by the Halle, Germany-headquartered biopharma firm as a potential treatment for Alzheimer’s disease.
The product targets and selectively clears the brain of existing pGlu-Abeta - the protein linked to the development of Alzheimer’s disease - leaving nontoxic forms of Abeta untouched, Glund said.
“PBD-C06 [has a] high specificity for pGlu-Abeta. Data from preventative and therapeutic studies in animal models have shown that PBD-C06 reduces soluble and insoluble pGlu-Abeta as well as total Abeta, and also rescues behavioural deficits.”
Senior Vice President of Project Management at Rentschler, Klaus Schoepe, said the CMO was “excited” to develop the mAb.
“We are confident our long-term expertise will deliver a first-class quality product and meet the challenging timelines of this project, which is targeting a disease affecting a substantial number of elderly people.”