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 CAR-T drug priority 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 includes a diversified portfolio of 10 novel pipeline products, including IASO's leading asset, Equecabtagene Autoleucel, an innovative anti-BCMA CAR-T cell therapy under pivotal study for relapsed/refractory multiple myeloma (R/R MM), which received NDA and priority review designation by China’s National Medical Products Administration (NMPA). Equecabtagene Autoleucel was granted “Breakthrough Therapy Designation” by the NMPA in February 2021 and granted “Orphan Drug Designation (ODD)” by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) in February 2022. In addition to multiple myeloma, the NMPA has accepted its IND application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). In addition, the company's in-house developed fully-human CD19/CD22 dual-targeted CAR-T cell therapy has entered phase 1/2 registrational clinical trial for the treatment of CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL). It was also granted Orphan Drug Designation by the U.S. Food and Drug Administration in October 2021.
NMPA Acceptance of the NDA for Equecabtagene Autoleucel（CT103A） for the Treatment of R/R MM
Equecabtagene Autoleucel for Treatment of NMOSD Receives IND Application Acceptance by NMPA
IASO Bio’s Nanjing Manufacturing Facility Granted the Drug Manufacturing License for CAR-T Cell Therapy Products
CT120 granted Orphan Drug Designation by the U.S. FDA
First patient enrolled for the phase I/II trial of CT120
Closed $108 Million Series C Funding
China IND approval for CT120
Oral presentation at 2021 European Hematology Association (EHA) Congress
Clinical trial results of CT103A commented in American Society of Hematology’s medical journal Blood
Breakthrough Therapy Designation granted to CT103A by the CDE
Pre-IND application for CT120
Commercial facilities completed and put into operation
Medical research commencing for fully-human nanobody RD125
First patient enrolled for the Phase II trial of CT103A
Fully-human dual-targeted CT120 kicking off IIT research
Starting construction of International R&D Center and manufacturing base
First patient enrolled for the Phase 1b trial of CT103A
Commencement of Shanghai R&D platform
Hillhouse Capital Group became the exclusive investor in the company's Series B fundraising with an investment of US$60 million.
Receiving Phase Ib/II approval for the CT103A IND application
Submitting the IND application in China for its first CAR-T product, CT103A.
Completing construction of its proprietary human antibody library
Completing Series A fundraising with proceeds of RMB 60 million
Partnering with Innovent Biologics in the development of autogenous CAR-T product based on BCMA targets
Setting up a GMP platform for research, development and intermediate testing of plasmids, viruses and cell
IASO Biotherapeutics was established
