Iaso Bio's Fully Human CD19/CD22 Dual-Targeting CAR-T Therapy CT120 Receives FDA Orphan Drug Designation for Acute Lymphoblastic Leukemia

NanjingPR Newswire / November 26, 2021 -- IASO Bio, a clinical-stage innovative biopharmaceutical company dedicated to the development and industrialization of cell therapies and antibody drugs, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has officially issued a written response granting Orphan Drug Designation (ODD) to the company's self-developed fully human anti-CD19 and CD22 dual-target chimeric antigen receptor autologous T-cell injection (CT120) for the treatment of Acute Lymphoblastic Leukemia (ALL). Receiving FDA Orphan Drug Designation will accelerate the clinical trials and marketing registration process of CT120 in the United States. The benefits CT120 will enjoy include FDA support for clinical research, waiver of registration fees, and seven years of market exclusivity in the U.S. upon FDA approval.

This orphan drug designation is based on the excellent safety and efficacy of CT120. In an investigator-initiated clinical study (registration number ChiCTR2000038641), all four B-ALL subjects achieved complete remission after receiving CT120 treatment, with a Complete Remission Rate (CRR) of 100%. No Grade 3 or higher CRS adverse reactions were reported, and no ICANS adverse reactions were observed. Therefore, CT120 is expected to become an innovative treatment for relapsed/refractory B-ALL.

Dr. Wang Wen, CEO of IASO Bio, stated：“CT120 is the world's first fully human dual-target CAR-T cell therapy product. The FDA has granted CT120 'Orphan Drug' designation, which is an affirmation and recognition of this product by the FDA. Currently, CT120 has obtained two IND approvals in China for B-NHL and B-ALL. The registrational clinical trial for the treatment of B-NHL in China is proceeding smoothly. IASO Bio will accelerate the development of this innovative product in both China and the United States, with the hope that this novel therapy will be launched soon to save more patients' lives!