October 31, 2019

Impact: High

  • China regulators have cleared the IND for the fully human BCMA CAR-T, CT-103A, in development by Nanjing Iaso and Innovent Biologics.
  • In the recent issue of BioWorld (pages 1 & 6), Brian Hall, VP of Business Development at Iaso, stated that a phase 1b/2 trial to confirm the recommended phase 2 dose is planned to start 1Q20 and will enroll 60-70 patients. Hall also notes a CT-103A approval is planned in 2H21.
  • In the investigator-initiated trial at Tongji Hospital, CT-103A treatment led to an ORR of 100% (sCR: 71%, CR: 88%) and four patients who relapsed on a previous murine BCMA CAR-T therapy have all achieved > VGPR. Onset of CRS occurred within 2-5 days and resolved within two weeks.

inThought Analysis

CT-103A is forging ahead in an extremely crowded BCMA CAR-T landscape. Data were presented at three conferences already this year (ASCO, EHA and IMW) and the responses in prior murine BCMA CAR-T failures were a frequent topic of expert discussion, supporting the notion of trials testing BCMA-targeted agents to include patients previously treated with BCMA therapies.

The 2021 approval laso has guided towards may be considered somewhat ambitious, but this does confirm that a regulatory pathway for CT-103A is being sought after. At the ASCO poster session, Brian Hall acknowledged that China regulatory agencies are becoming stricter in attempt to align with FDA and it will be harder to achieve approvals over time.

Source: BioWorld