Imugene (IMU) Study update presentation summary

Study design and patient population

• Phase 1/1b study enrolled 25 adults with relapsed/refractory CD19+ B-cell malignancies, all CAR T-naive and with a median of 2 prior therapies.

• Eligible diseases included DLBCL, MZL, CLL, FL, PCNSL, WM, and PMBCL.

• Recommended phase 2 regimen: 500M CAR T cells, lymphodepletion, and low-dose SC IL-2.

Technology and manufacturing

• Azer-cel is an allogeneic, off-the-shelf CAR T therapy using ARCUS gene editing for precise CD19 CAR insertion into the TRAC locus.

• Non-integrating AAV vector minimizes off-target editing and allows efficient delivery.

Efficacy outcomes

• Objective response rate (ORR) was high across all indications, with 100% ORR in CLL and MZL, and 79% in DLBCL/RT.

• ORR among patients with indolent disease was 93%.

• Ongoing responses and molecular disease burden reduction observed in MZL and CLL cohorts.