Imugene Advances Phase 1 onCARlytics Trial with IV Dose Escalation for Solid Tumours

Highlights

• Imugene Ltd (ASX:IMU) has progressed past the initial intravenous dose level in the Phase 1 onCARlytics trial following Cohort Review Committee clearance.
• The OASIS study continues evaluating onCARlytics in combination with blinatumomab to induce CD19 expression in solid tumours.
• The multi-centre trial across the US may expand to 10 sites, targeting enrolment of up to 50 patients with advanced, treatment-resistant solid tumours.

Imugene Ltd (ASX:IMU) has cleared the initial intravenous dose level in its Phase 1 onCARlytics clinical trial, marking a critical step forward in the development of novel immunotherapeutic strategies for advanced solid tumours. The progression follows the approval from the trial’s Cohort Review Committee (CRC) and enables the study to proceed to a higher dose level under its planned escalation protocol.

The ongoing clinical trial, known as the OASIS study, represents a first-in-human effort aimed at utilising onCARlytics—an innovative oncolytic virus—designed to induce the expression of CD19 in solid tumours. By enabling CD19 expression in otherwise CD19-negative solid tumours, onCARlytics seeks to make these tumours susceptible to established CD19-targeting immunotherapies, commonly used in hematologic malignancies.

The onCARlytics platform utilises a chimeric oncolytic virus called CF33-CD19, which selectively infects and destroys cancer cells while delivering a CD19 transgene. This approach aims to turn immunologically “cold” solid tumours into “hot” ones, capable of being targeted by bispecific T-cell engagers like blinatumomab, a monoclonal antibody already in clinical use for certain blood cancers.

The OASIS trial is being conducted in a dose escalation and expansion format, examining both intratumoural (IT) and intravenous (IV) routes of administration. It also includes combination therapy with blinatumomab (Blincyto®), which binds CD3 on T-cells and CD19 on cancer cells to direct immune-mediated tumour killing. The combination approach is being explored to amplify the immune response and broaden the applicability of CD19-directed therapies to solid tumour indications.

Currently underway at seven leading cancer centres across the United States—including institutions such as City of Hope, MD Anderson Cancer Center, and University of Pittsburgh—the study has the potential to expand to as many as 10 sites. The total planned enrolment for this Phase 1 trial includes between 40 and 50 adult patients with advanced or metastatic solid tumours that have proven resistant to conventional treatments.

The investigational approach being developed by Imugene Ltd (ASX:IMU) is targeting a critical limitation in the treatment of solid tumours. Unlike many hematological malignancies, solid cancers such as breast, lung, or gastric cancers typically lack a consistent, actionable surface antigen that can be therapeutically targeted. By leveraging onCARlytics to express CD19 on solid tumours, the company is working to unlock the potential of CD19-targeted therapies in these historically challenging cancer types.

The clinical trial is formally titled A Phase I, dose escalation and dose expansion, safety and tolerability study of onCARlytics (CF33-CD19), administered intravenously or intratumorally in combination with blinatumomab in adults with advanced or metastatic solid tumours. This study design allows for a thorough investigation into both safety and early signals of efficacy as different doses and administration methods are evaluated.

As dose escalation proceeds and more participants are enrolled, the study is expected to yield critical insights into the feasibility of repurposing CD19-based therapies beyond blood cancers. With the next dose level already underway, the trial is steadily progressing toward defining the optimal dosing regimen and establishing a safety profile that could support future clinical development stages.

This Phase 1 effort not only signals a promising therapeutic innovation but also aligns with broader trends in oncology research, where the use of viral vectors and immune system engineering are redefining the boundaries of cancer treatment. Imugene Ltd (ASX:IMU), through its onCARlytics program, continues advancing its pipeline of novel immunotherapies designed to reshape the treatment landscape for patients with high unmet medical needs in solid tumours.