On September 1, 2022 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has reached key next milestones in the trial (Press release, Imugene, SEP 1, 2022, View Source [SID1234618899]).
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The intratumoral (IT) cohort 1 has now cleared, which sees the opening of cohort 2 for IT administration, while in parallel intravenous (IV) cohort 1 has also opened. Multiple sites in the United States, have dosed the patients in IT cohort 1.
The Cohort Review Committee (CRC) unanimously agreed VAXINIA to be safe, with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed after CRC review of all safety and tolerability data for the first three patients dosed 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 cohort at the mid-dose level.
The multicenter Phase 1 trial has 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.
Once patients in the monotherapy group have been treated with the lowest doses of VAXINIA and acceptable safety has been demonstrated, new study participants will receive it in combination with the immunotherapy pembrolizumab. This is expected to begin following cohort 2 being cleared per route of administration. 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 is anticipated to run for approximately 24 months and is funded from existing budgets and resources.
Imugene MD & CEO, Ms Leslie Chong said: "Our VAXINIA trial has made headway since commencement in May. We expect this to continue as site activation and patient recruitment builds momentum and we look forward to updating our stakeholders as this positive progress continues throughout the year."