Highlights

• Imugene ended the June quarter with over AU$93 million in cash and equivalents, supporting operations through late 2025.
• The company is actively recruiting for three Phase 1/1b clinical trials across multiple countries.
• The Phase 1 onCARlytics trial for advanced solid tumors has seen its first patient dosed in the IV combination arm.
• The Phase 1 MAST dose escalation study has initiated its sixth cohort.

Clinical-stage immuno-oncology company Imugene Limited (ASX:IMU) made significant  progress with its clinical programs during the June quarter and ended the period with a cash position exceeding AU$93 million.

The company achieved several key milestones in its clinical trials. It is actively recruiting for three Phase 1/1b studies in the US, Australia, and the UK. Notably, recruitment for the Phase 1b study of azer-cel is ongoing, and the Phase 1 CF33-hNIS (VAXINIA) trial for bile tract cancer has recently opened. Additionally, the first patient was dosed in the IV combination arm of the Phase 1 onCARlytics trial, targeting advanced solid tumors.

As of the end of June, Imugene had AU$93.1 million in cash and equivalents. Additionally, the company expects an R&D tax rebate of approximately AU$11 million. The company believes this financial position provides sufficient runway to support its clinical pipeline and operations through late 2025.

Advances in Phase 1b Study for Azer-Cel

Azer-Cel is an innovative off-the-shelf cell therapy designed to target CD19 for the treatment of blood cancers. The ongoing Phase 1b allogeneic CAR T study focuses on patients with Diffuse-Large B-cell lymphoma (DLBCL), a challenging subset of non-Hodgkin’s lymphoma (NHL) that has relapsed after autologous CAR T therapy. This patient group faces limited treatment options and significant unmet medical needs.

Successful completion of this study could lead to a Phase 2/ registrational 3 study in 2025, potentially positioning azer-cel as the first approved allogeneic CAR T cell therapy for cancer.

Progress in Phase 1 MAST Dose Escalation Study

Aiming to enroll ten patients,  Phase 1 trial for bile tract cancer was initiated during the period.

Data source: Company update

The first patient was dosed after the quarter ended.  Additionally, the Phase 1 MAST monotherapy dose escalation study has progressed with the completion of the fifth cohort, and the sixth high-dose cohort is now underway.

Expansion of Phase 1 onCARlytics Study  

Towards the end of the quarter, Imugene dosed the first patient in the IV combination arm of the trial. The study, underway at three US sites, is targeting 40-45 patients with advanced solid tumors. The company plans to expand the study to ten locations. Preliminary data on the combination therapy is expected in 4Q 2024, depending on enrollment progress.

If successful, onCARlytics could advance CD19-targeted therapies for solid cancers.

During the quarter, Imugene also undertook significant corporate activities, reflecting ongoing developments and strategic initiatives.

Data source: Company update

IMU shares traded at AU$0.054 on 9 August 2024.