Janssen's CD3/CD22 Bispecific Antibody JNJ-75348780 Granted IND Approval in China for B-cell NHL and CLL

On April 8, the CDE website showed that Johnson & Johnson's JNJ-75348780 injection clinical trial application was approved for the treatment of B-cell non-Hodgkin lymphoma (B-cell NHL) and chronic lymphocytic leukemia (CLL). This is the first CD3/CD22 bispecific antibody to be clinically approved in China.

CD3 molecules can be linked to the T-cell antigen receptor (TCR), participating in T-cell signal transduction, and are used to mark thymocytes, T lymphocytes, and T-cell lymphomas. Therefore, CD3 is considered a recruitment target for T cells and a popular target for new drug development under immunotherapy treatment strategies.

In April 2009, catumaxomab (targeting CD3/EpCAM), a bispecific antibody developed by Trion Pharma, was approved for the treatment of malignant ascites (Chinese rights owned by Linton Pharmaceuticals); In December 2014, blinatumomab (targeting CD3/CD19), developed by Amgen, received FDA approval for the treatment of acute lymphoblastic leukemia; Tebentafusp, a bispecific TCR therapy developed by Immunocore (targeting CD3/gp100), received FDA approval on January 26, 2022, for the treatment of uveal melanoma.

CD22 is restrictively expressed on the surface of mature B cells and most malignant B lymphoma cells, making it one of the popular targets for the treatment of autoimmune diseases and B cell malignancies. There are two approved drugs targeting CD22: moxetumomab pasudotox (an anti-CD22 recombinant immunotoxin) from AstraZeneca and inotuzumab ozogamicin (a CD22 monoclonal antibody) from Pfizer.

Currently, JNJ-8780 is undergoing Phase I clinical trials abroad for the indications of non-Hodgkin lymphoma and chronic lymphocytic leukemia.