Imugene (ASX:IMU) has released Phase 1b data that show promising activity for its off-the-shelf allogeneic CAR T therapy Azer-cel in patients with relapsed or refractory B-cell malignancies who had not previously received autologous CAR T treatment.
Nineteen patients received Azer-cel with low-dose IL-2, and 16 were evaluable at the first disease assessment on day 28.
The group had a median age of 59 and included patients with diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), primary central nervous system lymphoma (PCNSL), follicular lymphoma (FL), and Waldenström macroglobulinemia (WM), many of whom had undergone multiple prior therapies.
Among the 16 evaluable patients, the overall response rate was 81 per cent with responses observed across several disease subtypes. Reported response rates included 60 per cent in DLBCL, with one complete response and two partial responses. A 100 per cent response rate in MZL with three complete responses and one partial response, 100 per cent in CLL with three partial responses, 50 per cent in PCNSL with one partial response and 100 per cent in both FL and WM, with one complete response in FL and one partial response in WM.
The abstract is posted on the ASCO website. An updated dataset will be presented at the ASCO meeting in Chicago on 29 May.
Imugene said the data support its clinical direction and the potential of its allogeneic platform.
Dr John Byon, MD, PhD, Imugene Chief Medical Officer, said, “Our ASCO 2026 abstract supports our clinical strategy and highlights the potential of our off-the-shelf allogeneic CAR T platform. The response rates seen in this CAR T naïve patient group, particularly in these heavily pre-treated patients across multiple blood cancer types, are very encouraging. We look forward to presenting the updated dataset during our oral presentation at ASCO next week.”
Managing Director and CEO, Leslie Chong, added, “We are excited to showcase these highly encouraging results during our oral presentation at ASCO next week. This represents an important milestone for Imugene and further increases the Company’s visibility to an international audience, including leading cancer experts, potential pharmaceutical partners, and global investors.”
Imugene said it has also opened a cohort testing Azer cel in combination with a Bruton Tyrosine Kinase inhibitor and added mantle cell lymphoma as an indication, with the combination arm enrolling patients who previously failed BTKi therapy.