Imugene Ltd (ASX:IMU, OTC:IUGNF) has confirmed that the phase 1 clinical trial of its oncolytic virotherapy candidate CHECKvacc will proceed to the second dose cohort at City of Hope, a world-renowned independent cancer research and treatment centre near Los Angeles.
Notably, the protocol management team agreed CHECKvacc to be safe with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed after review of all safety and tolerability data for the first three patients dosed with the lowest dose of CHECKvacc as monotherapy.
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).
Looking ahead, the trial is anticipated to run for 24 months and is funded from existing budgets and resources.
“No observed toxicity”
Imugene MD and CEO Leslie Chong said: “We are pleased with the results that we have seen so far 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.
"The Protocol Management Team for the study reviewed the first low dose cohort of patient’s data and has recommended to proceed to the next dose escalation due to safety and tolerability.
Clinical trial details
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' and will be led by principal investigator Dr Yuan MD, PhD.
Notably, the first-in-human, phase 1, single-centre, dose-escalation study of CHECKvacc is recruiting patients with triple-negative breast cancer (TNBC).
The purpose of the study is to evaluate the safety and initial evidence of the efficacy of intra-tumoural administration of CF33-hNIS-antiPDL1 against metastatic TNBC.
About CHECKvacc
CF33-hNIS-antiPDL1 (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 (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.
Furthermore, City of Hope’s preliminary animal studies demonstrated that tumour cells infected with CF33-hNIS-anti-PD-L1 successfully secrete functional hNIS and immune checkpoint.