On November 2, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its Phase 1 MAST (metastatic advanced solid tumours) trial evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has now cleared cohort 4 of the intravenous (IV) arm of the monotherapy dose escalation study, as well as IV cohort 2 of the combination study where VAXINIA is administered with blockbuster checkpoint inhibitor drug pembrolizumab (KEYTRUDA) (Press release, Imugene, NOV 2, 2023, https://mcusercontent.com/e38c43331936a9627acb6427c/files/17bdc1de-a079-186b-11e8-6ef4ab6ae92a/Next_cohort_reached_in_IV_arms_of_CF33_hNIS_VAXINIA_study.pdf [SID1234636670]).
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Cohort 5 of the IV arm for the monotherapy dose escalation is now open as is IV cohort 3 of the combination study.
Imugene MD & CEO Leslie Chong said: "As we near closer to opening and completing the final cohorts that were planned at the beginning of the trial, we have an opportunity to expand the trial by enrolling patients in additional cohorts for the monotherapy dose escalation component. This will provide us with a far more robust data set to analyse and speak to at the conclusion of the MAST study, and provide us with a stronger platform as we further the clinical development of CF33 and VAXINIA."
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 models. 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.