On June 24, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its CD19 oncolytic virotherapy drug candidate onCARlytics (CF33-CD19), has dosed the first patient in the intravenous (IV) infusion combination arm of the Phase 1 clinical trial (Press release, Imugene, JUN 24, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/0940c6f1-f44a-9947-a02a-a76749b0800a/Imugene_onCARlytics_Doses_First_Patient_in_IV_Combination.pdf [SID1234644492]).
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Known as OASIS, the Phase 1 dose escalation onCARlytics 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 of either onCARlytics (a CD19-expressing oncolytic virus) alone, or in combination with CD19 targeting bispecific monoclonal antibody blinatumomab (Blincyto), which is a cancer immunotherapy.
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."
OASIS is currently being conducted at three sites in the U.S. (City of Hope, University of Cincinnati, and 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. 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. 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. Subject to the rate of patient enrolment, preliminary early combination data are expected in the fourth quarter of 2024.
CD19 has been 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. 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 (valued at ~USD$532B by 2032¹).
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." See View Source