On August 14, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce that its Phase 1 MAST (metastatic advanced solid tumours) trial evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has cleared the cohort 3 intratumoral (IT) arm of the monotherapy dose escalation study (Press release, Imugene, AUG 14, 2023, View Source [SID1234634298]).
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This allows Imugene to commence recruitment for IT cohort 4 of the monotherapy dose escalation, whereby VAXINIA will be administered in three-to-six patients.
Imugene MD & CEO Leslie Chong said: "We continue to rapidly advance our monotherapy dose while the combination study continues its positive progress. We remain incredibly eager to bring the results of this trial to our shareholders, patients and the wider public."
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.