Amgen/BeiGene's CD3/STEAP1 Bispecific Antibody AMG 509 Becomes First-in-China Filed for Clinical Trial

On March 31, the CDE website showed that the clinical trial application of AMG 509, co-developed by Amgen and BeOne Medicines, was accepted. This is the first CD3/STEAP1 bispecific antibody to be clinically registered in China.

AMG 509 is a novel humanized bispecific T-cell engager antibody that binds to the STEAP1 antigen in humans and primates, as well as the CD3 receptor on the surface of T cells. STEAP1 is a cell surface antigen induced by androgens and highly expressed in prostate cancer, and it is also highly expressed in Ewing sarcoma (EWS).

In terms of structural design, AMG 509 is developed using Xencor's Xmab 2+1 asymmetric technology, which also extends its half-life. The drug consists of two identical humanized anti-STEAP1 Fab domains and one anti-CD3 scFv domain, where the anti-CD3 scFv domain is conjugated to one end of the STEAP1 Fab domain. The Fc domain is designed to lack Fc effector functions for enhanced safety, while also improving binding to FcRn to extend serum half-life.

Currently, Amgen is conducting a Phase I clinical trial for AMG 509 in metastatic castration-resistant prostate cancer (mCRPC) outside of China, with preliminary data expected to be released in the second half of this year.

In October 2019, BeOne Medicines and Amgen entered into a global oncology strategic partnership, granting BeOne Medicines the development and commercial rights in China for Amgen’s mature oncology products Xgeva (denosumab), Kyprolis (carfilzomib), and the bispecific antibody drug Blincyto (blinatumomab). In addition, BeOne Medicines will collaborate with Amgen globally to co-develop 20 of the latter’s pipeline oncology drugs targeting solid tumors and hematologic malignancies, including AMG 509. (See: )

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