• 14 Feb 2023
• Admin
• News Article

IASO Bio Announces CT103A Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations by the FDA

IASO Biotherapeutics a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, today announced 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). 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 CD3? 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 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. 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. IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput chimeric antigen receptor T-cell (CAR-T) drug screening platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. This pipeline includes a diversified portfolio of over 10 novel products, including IASO's leading asset, Equecabtagene Autoleucel (CT103A), a fully human BCMA CAR-T injection. Equecabtagene Autoleucel received New Drug Application (NDA) acceptance from as China's National Medical Products Administration (NMPA) for the treatment of RRMM and obtained the U.S. FDA IND approval. The company also received Breakthrough Therapy Designation (BTD) from the NMPA in February 2021 and Orphan Drug Designation (ODD) from the FDA in February 2022. In addition to multiple myeloma, NMPA has accepted its IND application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). Additionally, the company's in-house developed fully human CD19/CD22 dual-targeted CAR-T cell therapy has received two IND clearances for treating relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (r/r B-ALL). It is currently in Phase I clinical trial for r/r B-NHL. It was also granted ODD by the FDA in October 2021. Leveraging its strong management team, innovative product pipeline, integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable and affordable therapies that fulfil unmet medical needs to the patients in China as well as around the world