On June 9, 2023 : Imugene Limited (ASX: IMU), a clinical stage immunooncology company, reorted that its Phase 1 MAST (metastatic advanced solid tumours) trial evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has progressed to the next cohort of the intravenous (IV) arms of both the monotherapy and combination study (Press release, Imugene, JUN 9, 2023, View Source [SID1234632597]). As noted in the below graphic, the trial has now cleared cohort 3 and opened cohort 4 of the IV arm of the monotherapy dose escalation. In addition, cohort 1 of the IV arm of the combination study with Pembrolizumab has been cleared, allowing cohort 2 to be opened.
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Imugene MD & CEO Leslie Chong said: "As we continue to move through the cohorts at pace, we’re aiming to have this high-quality science peer reviewed and recognised within publications or conferences befitting of its results and potential benefit to patients in need."
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.