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Colin Hay

Immuno-oncology specialist Imugene (ASX: IMU) has dosed the first patient in the intravenous monotherapy arm of the Phase 1 clinical trial of its CD19 oncolytic virotherapy drug candidate onCARlytics.

Known as OASIS, the first-in-class clinical trial is targeting adult patients with advanced or metastatic solid tumours. The trial aims to evaluate the safety and efficacy of two routes of administration, intratumoural (IT) injection and intravenous (IV) infusion, either alone, or in combination with blinatumomab.

The trial is 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 Tumors.”

The combination arm of the study will include onCARlytics combined with CD19 targeting bispecific monoclonal antibody blinatumomab (marketed as Blincyto by Amgen).

onCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto therapy alone.

OASIS is a dose escalation trial being conducted in the United States, with the first IV patient dosed at City of Hope in California. Additional sites are expected to open for recruitment across the US with 52 patients proposed to take part in the trial.

“We’re pleased to see onCARlytics continue to advance in the clinic after the first patient on the trial was dosed in late October, and this move into intravenous administration marks another milestone in our mission to bring innovative cancer treatments to patients in need,” Imugene Managing Director and CEO, Leslie Chong, said.

“With the combination arm of the study still to come, we eagerly await the chance to see more on the potential onCARlytics holds."

onCARlytics is a CD19-expressing oncolytic virus that enters tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for CD19 targeting therapies.

Imugene is developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Its platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies.

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