Highlights
- First patients dosed in higher dose cohorts, cohort 5 of intratumoral and intravenous monotherapy arm.
- To date, 24 patients have been dosed in monotherapy arms and no safety issues have been reported.
- Across both monotherapy and combination arms, 38 patients have enrolled as of now.
Imugene (ASX: IMU) has further progressed with its Phase 1 MAST trial with the dosing of first patients in each arm of the higher dose cohort. Phase 1 trial is examining the safety of CF33-hNIS (VAXINIA). It is a cancer killing virus which was developed by the City of Hope.
Cohort 5 in the monotherapy dose escalation of the trial's intratumoural (IT) and intravenous (IV) arm are open. The first patients were dosed on 16 January under IT arm and on 18 January 2024 under IV arm.
The company is also advancing with the combination study in which VAXINIA is combined with pembrolizumab. New patients are enrolled actively and as of now, 13 patients have been enrolled.
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The company informed that the thymus cancer patient received treatment at St Vincent’s Hospital in Fitzroy, Victoria, while the melanoma cancer patient received treatment at UCSD in San Diego, California.
The Phase 1 MAST trial is a multi-centre study, initiated by administering a low dosage of VAXINIA to patients with metastatic or advanced solid tumours who have undergone minimum two prior rounds of standard care treatment. So far, no safety concerns have been observed. The trial has advanced through both monotherapy dose escalation cohorts and combination study involving the administration of VAXINIA alongside pembrolizumab. The overall goal of the trial is to enrol a maximum of 100 patients across ~10 trial sites in the US and Australia.
In May 2022, the study began and is likely to take nearly 24 months.
IMU shares up ~10%
IMU shares jumped 9.99% to trade at AU$0.110 apiece at the time of writing on 19 January 2024.