TJ-CD4B is the first clinical-stage bispecific antibody that binds to Claudin 18.2 (CLDN18.2)-expressing cancer cells and co-stimulatory molecule 4-1BB on immune cells to elicit a localized and combined immune response against solid tumors. It has potential application in a wide range of malignancies, particularly in gastric and pancreatic cancer. Preclinical studies have demonstrated superior CLDN18.2-dependent immune activation with TJ-CD4B as compared to 4-1BB monoclonal antibodies. In the preclinical data presented at the 2021 SITC Annual meeting, TJ-CD4B was well-tolerated with no evidence of systemic toxicity.

“The approval of IND marks a significant milestone for the Company, as TJ-CD4B will be the first CLDN18.2 x 4-1BB bispecific antibody of its kind to enter the clinical stage in China,” said Dr. Joan Shen, CEO of I-Mab. “TJ-CD4B has shown encouraging results in preclinical studies and the first-in-human dose escalation trial is ongoing in the U.S. smoothly. With the initiation of clinical study in China, we expect to advance TJ-CD4B rapidly and deliver a promising solution to aggressive cancer types that have a poor prognosis.”