February 15, 2022 -- IASO Biotherapeutics and Innovent Biologics jointly announced that the Office of Orphan Products Development at the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to their fully human, anti-B-cell maturation antigen (BCMA), CAR T-cell therapy CT103A/IBI326 for the treatment of relapsed and/or refractory multiple myeloma (R/R MM).
CT103A has been developed to address the adverse events and reinfusion challenges of previous high-dose BCMA-targeting CAR T cells. CT103A is a lentiviral vector containing a CAR structure with a fully human, single-chain variable fragment (scFv), CD8a hinger and transmembrane, 4-1BB co-stimulatory, and CD3ζ activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the BCMA CAR T is potent and persistent, the companies stated.
The designation will accelerate drug development and registration action of CT103A in the U.S. CT103A will be eligible for certain development incentives, including FDA support for clinical studies, a waiver or reduction of registration application fee, and a seven-year U.S. market exclusivity granted upon product approval. CT103A was also granted breakthrough therapy designation by China's National Medical Products Administration for the treatment of R/R MM.
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