First patient dosed in phase one clinical trial of new oncolytic virotherapy

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Clinical stage immuno-oncology company Imugene (ASX:IMU) has announced that the City of Hope cancer research and treatment centre has dosed the first patient in the Phase 1 clinical trial of its oncolytic virotherapy candidate, CHECKvacc (CF33-hNIS-antiPDL1).

The first-in-human, Phase 1, single-centre, dose-escalation study of CHECKvacc 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 clinical trial is titled 'A Phase I Study of Intratumoral Administration of CF33-hNIS-antiPDL1 in Patients with Advanced or Metastatic Triple-Negative Breast Cancer'.

According to principal investigator Dr Yuan Yuan, “There are limited options for triple-negative breast cancer patients, a meaningful new treatment would be very much welcomed by both patients and the medical community.

"Oncolytic viruses such as CHECKvacc certainly hold significant potential to improve clinical response and survival, and we’re looking forward to investigating this drug in patients.”

Imugene managing director and CEO Leslie Chong added, “Following the outstanding work of Professor Yuman Fong, Dr Yuan Yuan and the City of Hope team, in addition to the positive pre-clinical results, we’re incredibly eager to unlock the potential of CHECKvacc.

"It is timely that we see our first patient joining the trial during breast cancer awareness month, an issue that is particularly critical right now as mammograms and breast screening are down sharply due to COVID-19 restrictions. We hope that in time, CHECKvacc provides an improved outcome for the many women who are diagnosed every year. We look forward to seeing the results of this trial and bringing continued updates to the medical community and our stakeholders moving forward.”