Applied DNA's Linea DNA Gains Approval for Clinical Trial in CAR T-Cell Therapy

Applied DNA Sciences, Inc. has announced that its synthetic Linea DNA has achieved regulatory approval from the State Institute for Drug Control of the Czech Republic (SÚKL) for a Phase I clinical trial. Conducted by the Institute of Hematology and Blood Transfusion in Prague, the trial examines an investigational CAR T-cell therapy targeting CD123 for treating relapsed or refractory acute myeloid leukemia (AML).

AML, known for its high treatment failure rates, often leaves patients with limited therapeutic options. The UHKT-CAR123 trial aims to counter these challenges by employing a non-viral method with Linea DNA to expedite CAR T-cell production, potentially reducing both manufacturing costs and timelines. Preclinical studies have shown promising results with this Linea DNA-based approach, demonstrating rapid and efficient production of potent CAR T-cells.

This milestone highlights the clinical potential of Linea DNA, positioning it as a cost-effective tool in CAR T-cell therapy development. Applied DNA's CEO, Dr. James A. Hayward, noted the significance of this achievement as a precursor to upcoming trials planned for 2025.