Imugene Ltd (ASX:IMU, OTC:IUGNF) has dosed the first patient in the intravenous (IV) infusion combination arm of its Phase 1 onCARlytics trial.
The patient, suffering from cholangiocarcinoma (bile tract cancer), received treatment at City of Hope in California.
World-first oncolytic combination
Imugene’s OASIS trial marks a world-first in combining a CD19-expressing oncolytic virus with a CD19-targeting drug.
Managing director and CEO Leslie Chong said: “We are pleased to enrol the first IV combination patient and further advance our OASIS trial, which combines our CD19 oncolytic virus with the already approved and marketed CD19 bispecific in patients with advanced solid cancers.”
The Phase 1 dose escalation trial aims to evaluate the safety and efficacy of two administration routes—intratumoural (IT) injection and intravenous (IV) infusion—of onCARlytics (CF33-CD19).
This treatment may be administered alone or in combination with the CD19-targeting bispecific monoclonal antibody blinatumomab (Blincyto®), a cancer immunotherapy.
OASIS is currently being conducted at three sites in the United States - City of Hope, University of Cincinnati and MD Anderson Cancer Center.
There are plans to expand to a total of 10 sites to recruit around 40-45 patients with advanced solid cancers that have metastasised.
The primary objective is to assess the safety and efficacy of onCARlytics via IT injection or IV infusion, either as monotherapy or in combination with blinatumomab.
In February, the trial dosed its first patient with bile tract cancer in the IV monotherapy arm at City of Hope. Preliminary early combination data should be in by the fourth quarter of 2024.
Powerful target for blood cancers
CD19 has proven a powerful target for blood cancers, which constitute around 10% of all cancers. However, solid cancers, including breast, lung, gastric and colon cancers, lack a common surface target.
onCARlytics promise to address this by converting hard-to-treat “targetless” tumours into CD19-expressing solid tumours, making them susceptible to CD19-targeting therapies.
onCARlytics, a CD19 oncolytic virus, infects solid tumour cells and causes them to display the CD19 marker on their surface, thus becoming targets for approved CD19 therapies like blinatumomab.
This approach has the potential to open up CD19 therapies to 90% of the cancer market, valued at some US$532 billion by 2032.
“While CD19 has been a powerful target for blood cancers, no such targets currently exist for solid cancers.
“We aspire to change that with onCARlytics, which causes cancers to display CD19 on their cell surface so that an approved CD19 therapeutics can target and kill the cancer,” Chong said.
“If successful, onCARlytics could open up 90 per cent of the market as CD19 products are only approved in blood cancer and provide a new treatment option for patients with solid tumours.”