Imugene Ltd (ASX:IMU, OTC:IUGNF) and collaborator City of Hope®, one of the largest cancer research and treatment organisations in the United States, has dosed the first cohort two patient in the phase one clinical trial of its oncolytic virotherapy candidate, CHECKvacc.
Imugene is a clinical-stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours.
CHECKvacc is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong, Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, and a noted expert in the oncolytic virus field.
Oncolytic viruses 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.
First in-human study
The first-in-human, phase one clinical trial— a single-centre, dose-escalation study of CHECKvacc — is recruiting patients with triple-negative breast cancer to evaluate CHECKvacc's safety and initial evidence of efficacy against this metastatic cancer.
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 two dose
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".
Dr Yuan Yuan MD, PhD will lead the trial as principal investigator.
“We are pleased with the results that we have seen so far in cohort one, 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,” Imugene managing director and CEO Leslie Chong said.