Bayer’s AskBio to supply commercial-scale drug product for Regenerate-PD

AskBio, an independently operated as a subsidiary of Bayer (BAYRY) AG, announced that it has introduced its proprietary, commercially ready manufacturing process to supply ametefgene parvec, an investigational gene therapy for the treatment of Parkinson’s disease and multiple system atrophy-parkinsonian type, following submission of a United States Food and Drug Administration Investigational New Drug Application amendment. This enables AskBio to now advance its Regenerate-PD Phase II clinical trial in the United States with the material produced at the commercial manufacturing facility of AskBio’s wholly owned subsidiary, Viralgen, with other trial sites to follow, using an intensified, high-efficiency, next-generation, large-scale suspension manufacturing process that provides a consistently high-purity product.