Imugene Ltd (ASX:IMU, OTC:IUGNF) has dosed the first patient with bile tract cancer in the intravenous monotherapy arm of the Phase 1 onCARlytics clinical trial at City of Hope in California, USA.
Known as the OASIS trial, this is the first-in-class clinical trial targeting adult patients with advanced or metastatic solid tumours — a world-first in combining a CD19-expressing oncolytic virus with a CD19 targeting drug.
Imugene’s 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 managing director and CEO Leslie Chong said: “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.
“With the combination arm of the study still to come, we eagerly await the chance to see more on the potential onCARlytics holds."
Imugene expects 52 patients with advanced or metastatic solid tumours to be recruited for the trial, with additional sites expected to open for recruitment across the US.
Combination trial arm still to come
The OASIS 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 combination arm of the study will include onCARlytics combined with CD19 targeting bispecific monoclonal antibody blinatumomab (marketed as Blincyto® by Amgen (NASDAQ:AMGN)).
Imugene notes that onCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto® therapy alone.