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Imugene Limited (ASX:IMU)

ALERT: Price-sensitive ASX Announcement for IMU
Current share price for IMU : $0.090 -0.23 (-71.88%)+
Announcement
Release
8 Dec 2025 8:49AM
Price at Release
$0.320
Full Release
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Summary
Imugene Limited announced that the U.S. FDA has supported the strategy towards registration for their drug azercabtagene zapreleucel (azer-cel). The FDA has confirmed that data from the current Phase 1b study, which includes azer-cel combined with IL-2 dosing and lymphodepletion conditioning, supports moving forward to a Phase 3 registrational study. The FDA endorsed targeting 3rd line and later diffuse large B cell lymphoma (DLBCL) patients, including those relapsed after autologous CAR-T therapy, as the study population. The FDA also supported a single randomized study using Overall Response Rate (ORR) and durability for accelerated approval, and Progression Free Survival (PFS) for full approval. Imugene’s Chemistry Manufacturing Controls (CMC) program has been deemed suitable for initiating a registrational study. Clinical results have shown 82% ORR in CAR-T relapsed DLBCL and 83% in CAR-T naïve niche indications, highlighting the potential of azer-cel across multiple CD19-positive cancers.
Key Points
  • FDA confirmed data from current Phase 1b study supports Phase 3 registrational study for azer-cel.
  • 3rd line and later DLBCL, including CAR-T relapsed patients, accepted as study population.
  • Single randomized study with ORR and durability for accelerated approval; PFS for full approval supported.
  • FDA agreed with Imugene’s Chemistry Manufacturing Controls (CMC) readiness.
  • Clinical results: 82% ORR in CAR-T relapsed DLBCL; 83% response in CAR-T naïve niche indications.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.