On April 3, 2023 Imugene Limited (ASX: IMU), a clinical stage immunooncology company, reported that its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has dosed the first patients in the intravenous (IV) and intratumoral (IT) arms in cohort 3 of the monotherapy dose escalation trial (Press release, Imugene, APR 5, 2023, View Source [SID1234629813]).
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As noted below, the study continues its progression on schedule having now dosed patients in cohort 3 of the IV and IT arms of the monotherapy dose escalation, as well as cohort 1 of the study in combination with Pembrolizumab.
Imugene MD & CEO Leslie Chong said: "Still being less than 12 months since the very first patients were dosed, we’re now well advanced on amassing the critical data we require to publish on the outcomes of this study, and we remain very positive on the potential benefit to patients."
The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to 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 models¹. Overall the study aims to recruit up to 100 patients across approximately 10 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 commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.
Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484.