Imugene doses first patient in “hard to treat” cancer drug trial

Fresh from news of a “complete response” from other clinical trials last week, Imugene has now dosed the first patient with a drug combination that seeks to expose and target difficult-to-treat solid cancers.

The latest clinical trial will test Imugen’s “onCARlytics intratumoural” combination trial dose on a colorectal cancer patient at Northwestern University in the US.

The Phase-1 OASIS (oncolytic assessment and safety in solid tumours) trial is a world-first in clinical research which combines the company’s CD19 oncolytic virotherapy with a CD19-targeting bispecific monoclonal antibody known as blinatumomab (Blincyto® Amgen).

The primary objective of the OASIS trial is to assess the safety and tolerability of Imugene’s onCARlytics (CF33-CD19) when administered intravenously (IV - into a blood vessel) or intratumorally (IT - injected directly into a tumour) in combination with blinatumomab.

The company first kicked off its OASIS trials in October last year at the City of Hope’s NCI-designated comprehensive cancer centre in Duarte, California, with the dosing of its first patient living with ovarian cancer.

The groundbreaking trial targets adult patients with advanced or metastatic solid tumours, usually thought of as a patient group with limited treatment options.

The combination approach is designed to convert patients’ “targetless” tumours to ones which express CD-19 which is a characteristic bio-marker for B-cell development and lymphoma diagnosis.

Imugene’s onCARlytics has the potential to induce expression of CD19 on the surface of solid tumours which then permits existing CD19 therapies to recognise and attack the cancer.

The technique means “invisible” solid cancers can be effectively rendered visible and vulnerable to attack by approved CD19 drugs such as Amgen’s Blincyto® and Gilead’s Yescarta®.

Importantly, when combined with the CD19-targeting (Blincyto® Amgen) treatment, onCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto® or similar therapies on their own.

We are pleased to have dosed the first patient in the intratumoural arm of our OASIS trial. With CD19 being a well-established target in blood cancers, we are optimistic about the effectiveness it could show in solid tumours. onCARlytics has the potential to induce expression of CD19 on the surface of solid tumours and allow existing CD19 therapies to recognise and attack the cancer. We’re pleased to continue advancing this prospective new treatment option for those in need.

The trial is being undertaken across seven sites in the US and has the potential to be extended to a total of 10 sites, with a capability of accepting up to 40 patients with advanced solid cancers which have metastasised – or spread to other parts of the body away from the point of its initial development.

Metastasis occurs when cancer cells break away from the original (primary) tumour and travel through the blood or lymphatic system and form one or more new tumours in other organs or tissues.

Evaluation of the safety and efficacy of onCARlytics will be undertaken on both intratumoural (IT) and intravenous (IV) administrations of the therapy, either on its own or in combination with blinatumomab.

In February, the first patient with bile tract cancer was dosed in the intravenous (IV) monotherapy component of the trial at City of Hope in California.

Subject to the rate of patient enrolment, Imugene expects to roll out its preliminary IT and/or IV combination status is expected to begin in the fourth quarter of 2024.

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