Imugene Ltd (ASX:IMU, OTC:IUGNF) welcomes the news that the first patients have been dosed in its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA).
The patients were dosed in the intravenous and intratumoral cohorts of CF33-hNIS in combination with Pembrolizumab.
Setting an excellent pace
The trial recently cleared cohort two of the monotherapy dose escalation, and has now been able to progress to cohort one of the combination study and cohort three for both arms of the monotherapy dose escalation.
Imugene managing director and CEO Leslie Chong said: “Having continued through the monotherapy dose escalation with safety and early positive signals, we’re eager to see VAXINIA used in combination with the well-known drug Pembrolizumab and see the potential benefit this could bring to patients.
“We’re setting an excellent pace with the trial and look forward to data and results in due course.”
About the trial
The multi-centre Phase 1 MAST trial started with a low dose of VAXINIA in patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment.
The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.
Overall the study aims to recruit up to 100 patients across around ten trial sites in the United States and Australia.
The clinical trial is titled “A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST).”
The trial kicked off in May 2022 and is anticipated to run for some 24 months while being funded from existing budgets and resources.