The US Food and Drug Administration (FDA) has granted clearance to Imugene’s investigational new drug (IND) application for initiating a Phase I clinical trial of onCARlytics (on-CAR-19, CF33-CD19, HOV4), its oncolytic virotherapy candidate, to treat advanced or metastatic solid tumours.

A live, attenuated oncolytic orthopox (vaccinia) virus, CF33-CD19 encodes a truncated human CD19 transgene resulting in de novo CD19 expression at the tumour cell surface before virus-mediated tumour cell lysis.

The clearance allows Imugene to enrol and dose patients with advanced or metastatic solid tumours in its first-in-human (FIH) dose escalation study.

To be conducted in the US, the study intends to assess the efficacy and safety of CF33-CD19 alone or combined with blinatumomab (a bispecific CD19-directed CD3 T-cell engager [BiTE] specific to CD19 and CD3).

The treatment will be administered to patients by either intratumoral (IT) injection or intravenous (IV) infusion.

Imugene MD and CEO Leslie Chong said: “The start of our onCARlytics study, which is first-in-class, is a significant milestone for clinicians treating patients faced with the challenge of solid tumour cancers, which to date have been untreatable with CD19- targeting biological drugs.

“Accomplishing this goal speaks to the perseverance and dedication of Imugene’s and City of Hope’s research and development teams as we continue to build on our clinical and commercial potential.”

Last May, Imugene along with City of Hope dosed the first subject in Phase I study of a new cancer-killing virus, CF33-hNIS (Vaxinia), in patients with advanced solid tumours.