IASO Bio is a biopharmaceutical company engaged in discovery and development of novel cell therapies and biologics 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 portfolio of over 10 novel products, including FUCASO® (Equecabtagene Autoleucel). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of R/R MM. IASO also received Breakthrough Therapy Designation (BTD) from the NMPA in February 2021 and Orphan Drug Designation (ODD) from the FDA in February 2022, Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations from the FDA in February 2023. In addition to multiple myeloma, NMPA has approved IND application of FUCASO® for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD).
Additionally, the company's in-house developed fully human CD19/CD22 dual-targeted CAR-T cell therapy 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 for treatment of acute lymphoblastic leukemia by the FDA in October 2021. And the fully human monoclonal antibody targeting human CD19, IASO-782 Injection, received both FDA and NMPA IND approvals in June 2023 for use in U.S. and China clinical trials for Autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA).
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 patients in China as well as around the world.
IND for IASO-782 Injection was aprroved both by FAD and NMPA
NDA for Equecabtagene Autoleucel was approved by NMPA
CT103A Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations by the FDA
Closed Nearly $75 Million in Series C1 Funding
IND for CT103A was approved by the U.S. FDA for use in U.S. clinical trials for relapsed/refractory multiple myeloma (R/R MM)
Umoja Biopharma and IASO Biotherapeutics Announce Research Collaboration to Bring Off-the-Shelf Therapies to Patients with Hematological Malignancies
Cabaletta Bio and IASO Biotherapeutics Announce Exclusive Worldwide License Agreement for Clinically Validated CD19 Binder
IND application for CT103A new extended indication of NMOSD was approved by CDE
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