Imugene Ltd (ASX:IMU, OTC:IUGNF) has successfully progressed to the next stage of its Phase 1 clinical trial evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) in metastatic advanced solid tumours (MAST).
The company will now open cohort 2 for intravenous (IV) administration, having cleared IV cohort 1 and following on from the first patient being dosed as part of the intra-tumoral (IT) cohort 2 of the trial in October.
The Cohort Review Committee (CRC) again unanimously confirmed VAXINIA to be safe, with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed after the CRC reviewed all safety and tolerability data for the first three IV patients with the lowest dose of VAXINIA as monotherapy.
At completion of the review meeting, the CRC advised Imugene to proceed with opening the second VAXINIA Phase 1 IV cohort at the mid-dose level.
Positive momentum continues
“The MAST trial for VAXINIA has continued its positive momentum unimpeded to date, and again this is a credit to Imugene’s management,” Imugene managing director and CEO Dr Leslie Chong said.
“This momentum should be maintained with additional sites and broader patient recruitment as we move toward the new year.”
Once patients in the monotherapy group have been treated with the lowest doses of VAXINIA to the satisfaction of safety requirements, new study participants will receive it in combination with the immunotherapy pembrolizumab.
Imugene expects this phase of testing to begin following cohort 2 being cleared per route of administration.
Overall, the study aims to recruit up to 100 patients across some 10 trial sites in the United States and Australia.