Therapy Areas: Central Nervous System
Chinese regulator accepts IASO Biotherapeutics' IND application for Equecabtagene Autoleucel
30 May 2022 -

IASO Biotherapeutics (IASO Bio), a China-based clinical-stage biopharmaceutical company, announced on Saturday that it has received acceptance from China's National Medical Products Administration (NMPA) for its investigational new drug (IND) application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD) for a fully human BCMA chimeric antigen receptor autologous T (CAR-T) cell Injection (Equecabtagene Autoleucel, CT103A).

The NMPA acceptance is the world's first IND application for CAR-T in NMOSD.

The company's IND application is based on the Equecabtagene Autoleucel Investigator Initiated Trial (IIT) that enrolled patients with refractory NMOSD who were positive for Aquaporin 4 antibodies (AQP4). The company enrolled patients with poor symptom control despite around one year of treatment with around one immunosuppressant. The primary endpoint study was to observe the safety and tolerability and preliminary efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) related indicators in subjects with relapsed/refractory NMOSD treated with Equecabtagene Autoleucel. Effective 20 March 2022, patients received Equecabtagene Autoleucel cell reinfusion, including three in the 0.5×106 CAR-T cells/kg dose group, three in the 1.0×106 CAR-T cells/kg dose group in the dose escalation stage and six subjects in the expansion stage. The preliminary data indicated safety and efficacy of Equecabtagene Autoleucel in the 0.5×106 CAR-T cells/kg and 1.0×106 CAR-T cells/kg dose groups to treat NMOSD patients suffering from conditions that were poorly controlled by conventional therapies.

NMO is an acute or subacute inflammatory demyelination disorder of the central nervous system



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