IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company dedicated to discovering, developing, and manufacturing innovative cell therapies and antibody products, is delighted to announce that its investigational new drug, BCMA CAR-T CT103A (Equecabtagene Autoleucel), has been granted both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track (FT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (RRMM). This exciting news furthers IASO Bio’s commitment to providing life-saving therapies to those in need.
Equecabtagene autoleucel (CT103A) is a revolutionary BCMA chimeric antigen receptor autologous T cell injection that could potentially revolutionize the treatment of relapsed/refractory multiple myeloma (RRMM). Using a proprietary in-house optimization platform and integrated in-house manufacturing process improvement, the construct of CT103A is designed to be both potent and long-lasting. As a result, the NMPA has accepted the New Drug Application for equecabtagene autoleucel for the treatment of RRMM, and it has also been granted Breakthrough Therapy Designation, Orphan Drug Designation, and IND approval in the USA. Additionally, it has been approved by the NMPA for the expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). IASO Bio and Innovent Biologics, Inc. (1801.HK) are collaborating to develop equecabtagene autoleucel for the treatment of RRMM in mainland China. This cutting-edge medical technology could potentially be a game-changer in the fight against multiple myeloma.
About RMAT Designation
The 21st Century Cures Act established RMAT designation to help the FDA facilitate efficient drug development programs for treatments that can potentially address unmet medical needs for serious or life-threatening diseases or conditions. These treatments can include cell therapies, therapeutic tissue engineering products, human cell and tissue products, or any combination of these products. To qualify for RMAT designation, the drug must have preliminary clinical evidence showing that it has the potential to treat, modify, reverse or cure the condition or disease.
About FT Designation
Fast Track designation provides an opportunity to speed up the development and review of treatments for serious and life-threatening conditions that currently lack a treatment or have the potential to be superior to the current therapy. This expedited process could give patients access to drugs quicker than ever before. Additionally, with Fast Track designation, one may also be eligible for Accelerated Approval and Priority Review if specific requirements are met. The FDA will be in close contact with the clinical programs throughout the entire regulatory review process.
About IASO Bio
IASO Bio is a clinical-stage biopharmaceutical company that is revolutionizing the world of cancer and autoimmune disease treatments. Its proprietary fully human antibody discovery platform (IMARS), high-throughput chimeric antigen receptor T-cell (CAR-T) drug screening platform, and proprietary manufacturing processes have enabled the development of a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. Its leading asset, Equecabtagene Autoleucel (CT103A), a fully human BCMA CAR-T injection, has been granted New Drug Application (NDA) acceptance from China’s National Medical Products Administration (NMPA) for the treatment of RRMM, U.S. FDA IND approval, Breakthrough Therapy Designation (BTD) from the NMPA in February 2021 and Orphan Drug Designation (ODD) from the FDA in February 2022. The NMPA has also accepted its IND application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). Through its innovative and cutting-edge technologies, IASO Bio is helping to build a more hopeful future for cancer and autoimmune disease sufferers.
In October 2021, the FDA granted Orphan Drug Designation (ODD) to Sangamo Therapeutics’ in-house developed, fully human CD19/CD22 dual-targeted CAR-T cell therapy. This 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 undergoing Phase I clinical trial testing for r/r B-NHL, showing promise in its ability to treat these life-threatening diseases.
IASO is committed to delivering groundbreaking, cost-effective treatments to people suffering from unmet medical needs in China and beyond. With an experienced leadership team, a cutting-edge product portfolio, and comprehensive manufacturing and clinical expertise, IASO is revolutionizing the healthcare landscape and providing hope to patients globally.