On November 11, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported the dosing of the first patient in the intratumoural (IT) combination arm of its Phase 1 onCARlytics (CF33-CD19) clinical trial (Press release, Imugene, NOV 11, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/0b72d5aa-3410-e210-9537-71ef3b912378/onCARlytics_Trial_Doses_First_Patient_in_IT_Combination_Arm.pdf [SID1234648060]). This development is part of the OASIS trial, which is designed to assess the safety and efficacy of Imugene’s CD19 oncolytic virotherapy in patients with advanced or metastatic solid tumours.
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The OASIS trial is a Phase 1 dose escalation study that explores two routes of administration, intratumoural (IT) injection and intravenous (IV) infusion. onCARlytics, a CD19-expressing oncolytic virus, is being investigated both as a monotherapy and in combination with the CD19-targeting bispecific antibody blinatumomab, an established cancer immunotherapy.
Imugene Managing Director & CEO Leslie Chong said: "We are pleased to have dosed the first patient in the intratumoural arm of our OASIS trial. With CD19 being a well-established target in blood cancers, we are optimistic about the effectiveness it could show in solid tumours. onCARlytics has the potential to induce expression of CD19 on the surface of solid tumours and allowing existing CD19 therapies to recognise and attack the cancer. We’re pleased to continue advancing this prospective new treatment option for those in need."
OASIS is currently being conducted at seven sites in the U.S. including City of Hope, University of Cincinnati, and MD Anderson Cancer Center, with the potential to open a total of 10 sites to recruit up to approximately 40 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 IT and/or IV combination status is expected in the fourth quarter of 2024.
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