Janssen Submits IND Application for BCMA/CD3 Bispecific Antibody Teclistamab in China

On April 1, the CDE website showed that the clinical trial application (Acceptance No.: JXSL2101002/3) for Johnson & Johnson's BCMA/CD3 bispecific antibody Teclistamab injection was accepted by the CDE.

Teclistamab is a bispecific antibody developed using Genmab’s DuoBody® technology that simultaneously targets CD3 on T cells and BCMA on multiple myeloma (MM) cells. Teclistamab functions by recruiting cytotoxic T cells to the vicinity of BCMA-expressing MM cells, thereby activating T cells and inducing the killing of BCMA-positive cancer cells.

In December 2020, Johnson & Johnson announced the initial human Phase I clinical study (NCT03145181) data for teclistamab, which evaluated the efficacy of teclistamab in treating patients with relapsed or refractory multiple myeloma (MM).

Study results showed that among heavily pretreated patients, the overall response rate (ORR) in those receiving teclistamab at the Phase II clinical study recommended dose (RP2D, 1500 µg/kg) was 73% (16/22), with a partial response (PR) rate of 55% (12/22) and a complete response (CR) rate of 23% (5/22). After a median follow-up of 3.9 months (range: 1.7–7.4 months), 94% (15/16) of patients who achieved a response with RP2D treatment remained alive and progression-free.

Other companies in China developing BCMA/CD3 bispecific antibody therapies include Amgen (AMG 701) and Shandong New Era.