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IASO Biotheraputics' CT120 Granted Orphan Drug Designation by the U.S. FDA

SAN JOSE, Calif., NANJING, China and SHANGHAI, Nov.A 25, 2021 /PRNewswire/ -- IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company focusing on discovering, developing, and manufacturing innovative medicine announced onA Oct 26, 2021 that the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) has granted the Orphan Drug Designation (ODD) to the company's in-house developed fully human CD19/CD22 dual-targeted chimeric antigen receptor (CAR)-T cell therapy for the treatment of acute lymphoblastic leukemia (ALL).
IASO Biotheraputics' CT120 Granted Orphan Drug Designation by the U.S. FDA
The ODD is expected to accelerate the registration and launch of CT120 in the United States, where the product will be eligible to several preferential policies, including FDA support for clinical research, a waiver or reduction of certain fees, and seven years marketing exclusivity upon product approval. The ODD is based on the proven clinical safety and efficacy of CT120. In an investigator-initiated clinical study (Registration No: ChiCTR2000038641), all 4 subjects with B-cell ALL achieved complete response (CR) after treatment with CT120 treatment, with a complete remission rate (CRR) of 100%. No Grade 3 or higher cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. Based on these results, CT120 is expected to become an innovative treatment for patients with relapsed/refractory B-ALL.Dr. Wen (Maxwell) Wang, CEO of IASO Bio said, "CT120 is the first dual-targeted CAR-T cell therapy. The ODD granted to CT120 demonstrates the FDA's recognition and expectation of the product. CT120 has obtained two IND approvals for B-NHL and B-ALL in China, and the clinical trial for the treatment of B-NHL is going well. The company is advancing the development of the product in China and United States. We look forward to the launch of this innovative therapy to cure more patients."
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