Akeso Announces CDE Approval of AK132 (CLDN18.2/CD47 Bispecific Antibody) for Clinical Trials in Advanced Malignancies

Recently, the CDE official website showed that Akeso's AK132 injection has been approved for clinical use to treat advanced malignant tumors. This is the third CLDN18.2/CD47 bispecific antibody approved for clinical trials in China, following BC007 and SG1906.

CLDN18.2 is a tetraspanin protein with a complex structure. Under normal circumstances, CLDN18.2 is only expressed on the surface of epithelial cells in the differentiated gastric mucosa. After the occurrence of malignant tumors, tight junction proteins are disrupted, exposing the CLDN18.2 epitope on the surface of tumor cells. Studies have shown that CLDN18.2 is highly expressed in 50%-80% of gastric cancer patients and 60% of pancreatic cancer patients.

CD47 is highly expressed in various tumor cells. By binding to SIRPα on the surface of macrophages, it sends a "don't eat me" signal, inhibiting the phagocytic activity of macrophages. Targeting CD47 drugs, both as monotherapy and in combination therapy, has demonstrated promising anti-tumor efficacy in both hematological malignancies and solid tumors.

Currently, there are four CLDN18.2/CD47 bispecific antibodies under research and development globally: BC007 (Baochuan Biological Medicine Technology(Shanghai)Co.,Ltd., Phase I), PT886 (Phanes Therapeutics, Phase I), SG1906 (SUMGEN, Phase I), and AK132.

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