Imugene Limited (ASX: IMU), has dosed the first patient in the phase 1 clinical trial known as OASIS, which is testing its oncolytic virotherapy drug.
The clinical trial is targeting adult patients with advanced or metastatic solid tumours. The primary objective of the trial is to evaluate the safety and efficacy of onCARlytics, either by IT injection or IV infusion, either alone, or in combination with blinatumomab.
Imugene Managing Director & CEO Leslie Chong said: “We are pleased to enroll 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.
“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. “If successful, onCARlytics could open up 90 percent of the market as CD19 products are only approved in blood cancer and provide a new treatment option for patients with solid tumors.”
Imogen says OASIS is currently being conducted at three sites in the U.S., City of Hope, University of Cincinnati and the MD Anderson Cancer Center with the potential to open a total of 10 sites to recruit approximately 40-45 patients with advanced solid cancers that have spread.
In February, the first patient with bile tract cancer was dosed in the IV monotherapy arm of the trial at City of Hope in California.
Impgen said that subject to the rate of patient enrolment, preliminary early combination data is expected in the fourth quarter of 2024.
CD19 has proven a powerful target for blood cancers, which make up around 10% of all cancers. Solid cancers like breast, lung, gastric, and colon, etc. do not have a common target on their cell surface and so the goal of onCARlytics is to present a target for CD19 therapies.
onCARlytics is a CD19 oncolytic virus that enters solid tumor cells and causes them to display a marker or protein on the surface of the cancer cell called CD19, thus making the cancer cell a target for already approved CD19-targeting drugs, such as blinatumomab, that kill blood cancers with CD19 targets on their cells.
Imogen said that if successful, onCARlytics could open up 90% of the cancer market and allow CD19 therapies to become an option to treat patients with solid tumors.
IMU was trading at 5.9 cents.