AskBio’s Viralgen to Supply Commercial-Scale Drug Product for Parkinson’s Trial

AskBio Inc., a gene therapy company and a subsidiary of Bayer AG, has introduced its commercially ready manufacturing process to supply ametefgene parvec (AB-1005), an investigational gene therapy for the treatment of Parkinson’s disease (PD) and multiple system atrophy-parkinsonian type (MSA-P), following submission of a U.S. FDA Investigational New Drug Application (IND) amendment.  

This enables AskBio to advance its REGENERATE-PD Phase II clinical trial in the U. S. with the material produced at the commercial manufacturing facility of AskBio’s wholly owned subsidiary, Viralgen, using an intensified, high-efficiency, large-scale suspension manufacturing process that provides a consistently high-purity product. 

“Today’s news marks another important advancement in our Parkinson’s program,” said Canwen Jiang, MD, PhD, Chief Development Officer and Chief Medical Officer at AskBio. “We are initiating supply with our manufacturing platform, to deliver our investigational gene therapy to participants in our ametefgene parvec trials, including our REGENERATE-PD trial, which recently saw the randomization of our first participants in Germany. The trial is currently enrolling participants in Poland, the United Kingdom, and the United States.”  

“Manufacturing efficiency of our AAV gene therapy-based drug product is mission critical for our Phase II Parkinson’s disease trial,” said Christian Rommel, PhD, Global Head of R&D for Bayer’s Pharmaceuticals Division. “It underscores the innovation of our production technology and reflects our continued commitment to meet high regulatory standards.” 

In December 2025, AskBio was granted Pioneering Regenerative Medical Product designation (SAKIGAKE) in Japan for ametefgene parvec, and in February 2025 the company was granted Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. Prior to that, AskBio received FDA Fast Track designation and the Innovation Passport, the UK MHRA innovative medicine designation. All designations were for PD.