Clinical stage immuno-oncology company Imugene (ASX:IMU) says City of Hope, one of the largest cancer research and treatment organizations in the US, has dosed the first cohort two patient in the Phase I clinical trial of oncolytic virotherapy candidate, CHECKvacc (CF33-hNIS-antiPDL1).
The first-in-human, Phase 1, single-centre, dose-escalation study is recruiting patients with triple-negative breast cancer (TNBC).
The company said the purpose of the study is to evaluate the safety and initial evidence of the efficacy of intra-tumoral administration of CF33-hNIS-antiPDL1 against metastatic TNBC.
The current trial design will involve a dose escalation, followed by an expansion to 12 patients at the final dose, which will be the recommended phase 2 dose (RP2D).
The trial's principal investigator leading the trial is Dr Yuan Yuan.
Imugene managing director and CEO Leslie Chong said, “We are pleased with the results that we have seen so far in cohort 1 with no observed toxicity with early encouraging results in oncolytic virus infection and replication in the TNBC tumours. We look forward to continuing this study and reporting to the market of its progress.”
CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong. Professor Fong is the Sangiacomo Family Chair in Surgical Oncology at City of Hope.
Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival.