Andelyn Biosciences AAV Curator Platform used to manufacture clinical grade viral vector for FDA-authorized first-in-world universal donor CRISPR/AAV transduced CAR-NK cells

Andelyn Biosciences, Inc., a leading and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has manufactured viral vector with its AAV Curator^® Platform for Nationwide Children's Hospital's Cellular Therapy and Cancer Immunology Program. The Adeno-Associated Virus (AAV) will be utilized in a novel cell therapy for Universal-Donor CD38KO CD33CAR-NK cells, to be studied in a forthcoming clinical trial. The Phase 1 trial will study the safety of the novel therapy in patients with advanced, high-risk acute myeloid leukemia (AML).

Within the field of cell therapy, there is a consistent need from researchers to manufacture cGMP virus to support the advancements of these critical therapies. While many AAV manufacturing platforms are specifically designed to be scaled to support large scale indications, Andelyn's AAV Curator^® Platform utilizes Optimization-by-Design^™ to be correctly sized for scale and speed to the clinic. The well-established platform allows for the ability to support the exacting viral vector manufacturing needs of the NCH NK cells created on the hospital's patented universal-donor NK cell platform.

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

Andelyn is enabling the progression of life-altering cell and gene therapies for both rare and prevalent diseases with the highest quality standards and scalable end-to-end development and manufacturing capabilities at its Columbus, Ohio facilities.

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