On February 12, 2023 IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, reported that the U.S. Food and Drug Administration (FDA) has granted both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track (FT) designation to its investigational new drug BCMA CAR-T CT103A (Equecabtagene Autoleucel) for relapsed/refractory multiple myeloma (RRMM) (Press release, IASO Biotherapeutics, FEB 12, 2023, View Source [SID1234627086]).
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About CT103A
Equecabtagene autoleucel (CT103A) is a BCMA chimeric antigen receptor autologous T cell injection, a lentiviral vector containing a CAR structure with a fully human 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, and integrated in-house manufacturing process improvement, the construct of CT103A is potent and shows prolonged persistency in patients. The NMPA accepted the New Drug Application for equecabtagene autoleucel for the treatment of relapsed/refractory multiple myeloma (RRMM). Equecabtagene autoleucel also received Breakthrough Therapy Designation by the NMPA in February 2021 and Orphan Drug Designation (ODD) in February 2022 and IND approval in December 2022 by the U.S. FDA. In addition to multiple myeloma, the NMPA has approved IND application of equecabtagene autoleucel for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). IASO Bio and Innovent Biologics, Inc. (1801.HK) are jointly developing equecabtagene autoleucel for the treatment of RRMM in mainland China.
About RMAT Designation
Established under the 21st Century Cures Act, RMAT designation is intended to help the FDA facilitate an efficient development program of any drug that (1) qualifies as RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products; (2) is intended to treat, modify, reverse or cure a serious or life threatening disease or condition; and (3) has preliminary clinical evidence to indicated the drug has the potential to address unmet medical needs for such a disease or condition.
About FT Designation
Fast Track designation is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available, thus enabling drugs to potentially reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.