On January 19, 2024 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 continued to progress with the first patients dosed in each arm of the higher dose cohort as part of the Phase 1 study (Press release, Imugene, JAN 19, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/bd9faf72-2b60-04da-3899-77e9cf4d3704/VAXINIA_Phase_1_trial_doses_patients_in_higher_dose_cohorts.pdf [SID1234639338]).
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In the monotherapy dose escalation, cohort 5 of the trial’s intratumoural (IT) and intravenous (IV) arm are now open with the first patients dosed on 16 January and 18 January 2024, respectively. The combination study, where VAXINIA is administered with pembrolizumab, also continues to actively enrol new patients with 13 patients enrolled to date.
Imugene Managing Director & CEO Leslie Chong said: "Following the positive news on VAXINIA’s early signals and FDA Fast Track Designation to end 2023, we are pleased to start the new year by announcing the ongoing progress of the MAST trial as we continue to see no safety issues with the drug. We also look forward to expanding the trial to take a closer look at bile duct cancer where we’ve seen early encouraging results."
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. With no safety signals identified to date, the trial has since progressed through the monotherapy dose escalation cohorts as well as the combination study, whereby VAXINIA is administered with well-known checkpoint inhibitor pembrolizumab. The City of Hope-developed CF33 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.