Andelyn Biosciences Manufactures AAV Vector for Upcoming AML Cell Therapy Trial

• Andelyn Biosciences has manufactured an AAV vector using its AAV Curator Platform for a Phase 1 clinical trial led by Nationwide Children’s Hospital.

• The AAV will be used in a universal-donor CD38KO CD33CAR-NK cell therapy for high-risk acute myeloid leukaemia (AML).

Andelyn Biosciences, Inc., a contract development and manufacturing organisation (CDMO), has produced an Adeno-Associated Virus (AAV) vector to support a forthcoming Phase 1 trial initiated by Nationwide Children’s Hospital (NCH). The trial will evaluate a universal-donor CD38KO CD33CAR-NK cell therapy in patients with advanced, high-risk acute myeloid leukaemia (AML).

The viral vector was manufactured using Andelyn’s proprietary AAV Curator Platform. The technology is tailored for clinical-scale speed and flexibility, using what the company describes as an Optimization-by-Design approach. This approach allows the platform to address the specific manufacturing requirements of novel therapies like NCH’s universal-donor natural killer (NK) cell platform.

According to the release, there is a growing need within the cell therapy field for cGMP-compliant viral vector production. Unlike some AAV manufacturing systems that are designed for large-scale indications, the Curator Platform is optimised for precision scale-up and expedited clinical deployment.

“We are excited to be playing a key role in this very promising Universal Donor CD38KO CD33CAR-NK cell therapy technology by NCH,” said Matt Niloff, Chief Commercial Officer at Andelyn. “We look forward to the clinical trial ushering in a new era for patients with AML and other blood cancers.”