I-Mab Receives IND Approval For Phase 1 Clinical Trial Of Bispecific Antibody TJ-CD4B in Solid Tumors In China

I-Mab, a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved the IND submission for the initiation of a phase 1 clinical study of the bispecific antibody TJ-CD4B (also known as ABL111) in patients with solid tumors, including gastric cancer, gastroesophageal junction carcinoma, esophageal adenocarcinoma, and pancreatic ductal carcinoma in China.

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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.

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“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.”

The phase 1 clinical study in China will be conducted as the dose-expansion portion of an ongoing trial (NCT04900818) initiated in June this year in patients with advanced solid tumors in the U.S., which will accelerate the overall clinical development of TJ-CD4B.

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