On February 15, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its CD19 oncolytic virotherapy drug candidate onCARlytics (on-CAR-19, CF33-CD19 HOV4), has dosed the first patient in the intravenous monotherapy arm of the Phase 1 clinical trial (Press release, Imugene, FEB 15, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/7ffe1327-a379-db3f-e3a1-90fed6834c49/Phase_1_onCARlytics_Trial_Doses_First_Intravenous_Patient.pdf [SID1234640107]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Known as OASIS, the first-in-class 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, either alone, or in combination with blinatumomab.
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
The combination arm of the study will include onCARlytics combined with CD19 targeting bispecific monoclonal antibody blinatumomab (marketed as Blincyto by Amgen).
onCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto therapy alone.
OASIS is a dose escalation trial being conducted in the United States, with the first IV patient dosed at City of Hope in California. Additional sites are expected to open for recruitment across the US with 52 patients proposed to take part in the trial.
Imugene Managing Director and CEO Leslie Chong said: "We’re pleased to see onCARlytics continue to advance in the clinic after the first patient on the trial was dosed in late October, and this move into intravenous administration marks another milestone in our mission to bring innovative cancer treatments to patients in need. With the combination arm of the study still to come, we eagerly await the chance to see more on the potential onCARlytics holds."
onCARlytics is a CD19-expressing oncolytic virus that enters tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for CD19 targeting therapies.