Amgen Launches Phase II Clinical Trial of CD3/CD19 Bispecific Antibody for Lupus Nephritis

▎Armstrong

On October 30, 2024, Amgen released its third-quarter report, with revenue of $8.151 billion, a year-on-year increase of 23%. Excluding the impact of the acquisition of Horizon, revenue grew by 8%.

In the oncology business segment, the Q3 sales of the CD3/CD19 bispecific antibody Blincyto reached $327 million, a year-over-year increase of 49%. The first-quarter sales of the DLL3/CD3 bispecific antibody Imdelltra for small cell lung cancer amounted to $36 million.

Blincyto is exploring a subcutaneous formulation, and the Phase 1/2 clinical trial for B-ALL has completed enrollment. It is expected to advance to Phase 2 registrational clinical trials in the second half of 2025.

Amgen is actively expanding into the autoimmune field, with CD3/CD19 bispecific antibodies and CD19 monoclonal antibodies having initiated Phase II clinical trials for lupus nephritis.

The Phase 2a clinical trial plans to enroll 50 participants, with the CD3/CD19 bispecific antibody administered via subcutaneous injection. Safety endpoints will be observed over 52 weeks, and efficacy endpoints at 12 weeks and 24 weeks.

Summary

Blincyto is the world's first and only approved CD3/CD19 bispecific antibody, and the first to advance to Phase II clinical trials in this wave of autoimmune innovation. Cullinan has just initiated a Phase 1b clinical trial, planning to enroll 24 lupus patients. Merck acquired Toren Bio's CD3/CD19 bispecific antibody for $700 million, while GSK acquired Triumvira Bio's CD3/CD19/CD20 bispecific antibody for $850 million. Xencor announced that its CD3/CD20 bispecific antibody and CD3/CD19 bispecific antibody will be redirected to the autoimmune field. Candid acquired JH Bio's CD3/CD20 bispecific antibody and EpimAb Bio's CD3/BCMA bispecific antibody.