AskBio advances Phase II gene therapy with commercial supply

AskBio, a gene therapy developer and subsidiary of Bayer AG, announced it has implemented a commercially ready manufacturing process to supply its investigational gene therapy ametefgene parvec (AB-1005) for a Phase II clinical trial, following submission of an FDA investigational new drug amendment.

The therapy will be manufactured at the commercial-scale facility of Viralgen Vector Core, enabling supply for the Regenerate-PD trial in the U.S., with additional sites planned globally. According to the announcement, the process uses an intensified, large-scale suspension manufacturing platform designed to deliver high-purity adeno-associated virus (AAV) drug product with improved efficiency and consistency.

The company said the transition to a commercially ready process is intended to support clinical supply continuity and future scale-up requirements, aligning manufacturing with late-stage development needs. The approach is focused on maintaining product quality while increasing output to meet expanding trial demand.

The Regenerate-PD study is evaluating the therapy for Parkinson’s disease, with enrollment underway across multiple regions. AskBio is also advancing additional clinical studies for related neurodegenerative indications, according to the company.

The manufacturing milestone builds on prior commercial-scale production activity at Viralgen, including support for external gene therapy programs preparing for potential launch, reflecting broader investment in AAV manufacturing capacity and readiness for late-stage and commercial supply.