Imugenes onCARlytics Granted FDA Clearance to Initiate First-in-Class Clinical Study

May 19, 2023

Imugene Limited (ASX: IMU), a clinical-stage immune-oncology company, has obtained Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to commence a Phase 1 clinical study for their oncolytic virotherapy candidate, onCARlytics (on-CAR-19, CF33-CD19, HOV4). This milestone allows Imugene to initiate patient recruitment and dosing in a ground-breaking Phase 1 clinical trial called OASIS.

The study aims to evaluate the safety and tolerability of onCARlytics administered intravenously or intratumorally in combination with Blinatumomab in adults with advanced or metastatic solid tumors. By combining Imugene's CF33-CD19 oncolytic virus with Blinatumomab, onCARlytics shows potential in targeting and eliminating solid tumors that were previously untreatable with CD19-targeting biological drugs. Imugene's CEO, Leslie Chong, expressed the significance of this FDA clearance, highlighting the advancements in treating solid tumor cancers and the dedication of Imugene and City of Hopes research and development teams.

 

 

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