Highlights

• The first patient has received treatment under the intravenous (IV) infusion combination arm of the Phase 1 onCARlytics trial.
• The trial aims to enrol nearly 40-45 patients with advanced solid cancers that have spread.
• Preliminary early combination data are expected in 4Q24.

Imugene Limited (ASX: IMU) has progressed its Phase 1 onCARlytics (CF33-CD19) clinical trial by administering the first dose to a patient with cholangiocarcinoma or bile tract cancer in the intravenous (IV) infusion combination arm.

The Phase 1 dose escalation onCARlytics clinical trial, known as OASIS, is a world-first trial combining a CD19-expressing oncolytic virus with a CD19-targeting drug. The trial specifically targets adult patients diagnosed with advanced or metastatic solid tumours.

The primary objective of the trial is to assess the safety and efficacy of two methods of administration —intratumoral (IT) injection and intravenous (IV) infusion—of onCARlytics alone or in combination with the CD19-targeting bispecific monoclonal antibody blinatumomab (Blincyto®), a form of cancer immunotherapy.

Details of the OASIS trial

Title of the trial is –

Data source: Company update

The OASIS trial is currently underway at three U.S. sites: City of Hope, University of Cincinnati, and MD Anderson Cancer Center. The trial has the potential to expand to a total of 10 sites, recruiting nearly 40-45 patients with advanced solid cancers that have spread.

In February, the company informed that the first bile tract cancer patient was administered under the IV monotherapy arm at the City of Hope, California.

Depending on the patient enrolment rate, initial early combination data is anticipated in the fourth quarter of 2024.

About onCARlytics  

CD19 has been an effective target for blood cancers, which account for approximately 10% of all cancers. However, solid tumours, such as those in the breast, lung, stomach, and colon, lack a common target on their cell surfaces and onCARlytics assists in presenting a common target for CD19 therapies.

onCARlytics is a CD19 oncolytic virus which move into solid tumour cells and induce them to display the CD19 marker on their surfaces. This transformation makes the cancer cell a target for existing CD19-targeting drugs, including blinatumomab, which kill blood cancers with CD19 targeting on their cells.

If this trial shows positive outcomes, then onCARlytics could potentially open up 90% of the cancer market, highlights the company update. This breakthrough could significantly increase the options available for treating patients with solid tumours, a market projected to be worth approximately US$532 billion by 2032 (as per data presented by the Precedence Research).

IMU shares were trading at AU$0.056 apiece at the time of writing on 24 June 2024.