- AskBio has introduced a commercial-ready manufacturing process to supply its investigational gene therapy, ametefgene parvec (AB-1005), following an FDA IND amendment.
- The process will support the REGENERATE-PD Phase II clinical trial using material produced at Viralgen’s manufacturing facility.
AskBio Inc. has introduced a commercially ready manufacturing process to supply ametefgene parvec (AB-1005), an investigational gene therapy targeting Parkinson’s disease and multiple system atrophy-parkinsonian type. The development follows the submission of an Investigational New Drug (IND) amendment to the United States Food and Drug Administration.
The new process enables AskBio to advance its REGENERATE-PD Phase II clinical trial in the United States. Trial material will be produced at the commercial manufacturing facility of Viralgen, a wholly owned subsidiary of AskBio. The company is using an intensified, next-generation large-scale suspension manufacturing process designed to deliver consistent product purity.
The REGENERATE-PD trial is currently enrolling participants across multiple regions, including the United States, Poland, and the United Kingdom. The study has also initiated participant randomization in Germany. The investigational therapy is also being evaluated in a fully enrolled Phase I trial in the United States for patients with the parkinsonian subtype of multiple system atrophy.
“Today’s news marks another important advancement in our Parkinson’s program. We are initiating supply with our manufacturing platform, to deliver our investigational gene therapy to participants in our ametefgene parvec trials.”
Canwen Jiang, MD, PhD, Chief Development Officer and Chief Medical Officer at AskBio
AskBio has received multiple regulatory designations for ametefgene parvec, including Regenerative Medicine Advanced Therapy designation from the FDA, Pioneering Regenerative Medical Product designation in Japan, and Fast Track and Innovation Passport designations in the United States and the United Kingdom. The therapy remains investigational and has not been approved by any regulatory authority.
