On October 25, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its CD19 oncolytic virotherapy drug candidate onCARlytics, has commenced a Phase 1 clinical trial, with the first patient now dosed (Press release, Imugene, OCT 25, 2023, View Source [SID1234636338]).
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The first-in-class Phase 1 clinical trial of onCARlytics (on-CAR-19, CF33-CD19 HOV4), known as OASIS, is being conducted in patients with solid tumours and 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
When combined with the CD19 targeting bispecific monoclonal antibody blinatumomab (Blincyto Amgen), onCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto therapy alone. The clinical trial, for adult patients with advanced or metastatic solid tumours, aims to evaluate the safety and efficacy of two routes of administration, intratumoral (IT) injection and intravenous (IV) infusion, either alone, or in combination with blinatumomab.
The study is a dose escalation trial and is being conducted in the United States. The first patient with ovarian cancer has been dosed at City of Hope’s NCI-Designated Comprehensive Cancer Center in Duarte, California, USA.
Imugene Managing Director and CEO Leslie Chong said: "This is a milestone we’ve been eagerly anticipating, given the encouraging signs we have seen from the pre-clinical work performed to date. We believe onCARlytics may provide a new solution for clinicians treating solid tumours that have previously been untreatable using CD19-targeting biological drugs, and we hope our technology can bring much needed relief to patients in want of new treatments."
I am particularly pleased with the speed at which our team drove the pre-clinical data from a novel therapy, into a Phase 1 trial in a little over two years, and reflects the enthusiasm for this promising therapy, from all involved."