On February 2, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to reported that its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has cleared cohort 2 of both the intravenous (IV) and intratumoral (IT) arms of the monotherapy trial, allowing it to open cohort 1 of the combination study (with Pembrolizumab) and cohort 3 for both arms of the monotherapy dose escalation (Press release, Imugene, FEB 2, 2023, https://mcusercontent.com/e38c43331936a9627acb6427c/files/6edfd8aa-45a9-b542-d933-70735f592bbf/Imugene_VAXINIA_trial_advances_to_Combination_Cohort.pdf [SID1234626725]).
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The company announced the first patient had been dosed in IV cohort 2 on 5 December 2022, with the trial continuing its unimpeded progress since.
Imugene MD & CEO Leslie Chong said: "Early data arising from our patients dosed at low levels with our CF33 oncolytic virus have indicated immune activation is occurring in the tumour microenvironment, turning the tumour from ‘immunologically cold to hot’. This is a perfect time to introduce an immune checkpoint inhibitor such as pembrolizumab."
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.
The patients treated to date in the monotherapy group have received the lowest doses of VAXINIA and have demonstrated acceptable safety, allowing new study participants to receive it in combination with the immunotherapy pembrolizumab. 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.