On May 19, 2023 Imugene Limited (ASX:IMU), a clinical stage immuno oncology company, reported that it has received US Food and Drug Administration (FDA) Investigational New Drug (IND) clearance to initiate a Phase 1 clinical study of its oncolytic virotherapy candidate, onCARlytics (on-CAR-19, CF33-CD19, HOV4) (Press release, Imugene, MAY 19, 2023, View Source [SID1234631874]).

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The FDA clearance of the IND allows Imugene to start patient recruitment and dosing in a first-in-class Phase 1 clinical study for the onCARlytics platform in patients with solid tumours: "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 (OASIS)."

Imugene’s CF33-CD19 oncolytic virus, when combined with the CD19 targeting bispecific monoclonal antibody blinatumomab (Blincyto), has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto therapy alone.