I-Mab has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its novel Claudin 18.2 x 4-1BB bispecific antibody, TJ-CD4B, to treat gastric cancer, including cancer of gastroesophageal junction. 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 T cells, employing a tumor-killing effect. Because it covers cancers that express low levels of CLDN18.2, TJ-CD4B’s anti-tumor effect is broader than other therapies that involve CLDN18.2. Preclinical studies have also proposed TJ-CD4B’s superiority to current CLDN18.2 antibodies and 4-1BB agonistic antibodies because of its stronger anti-tumor activity and a minimal 4-1BB related systemic toxicity. Gastric cancer represents about 1.5% of all new cancers diagnosed in the U.S. and, globally, is the fifth most common cancer as well as the third most common cause of death due to cancers. I-Mab is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of novel biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders.

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