Highlights
- Imugene Limited (ASX:IMU) makes headway in its Phase I VAXINIA clinical trial, which evaluates the safety of VAXINIA, a cancer-killing virus, CF33-hNIS.
- 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.
- A total of 100 patients will be recruited for about 10 trial sites in the United States and Australia.
Clinical-stage immuno-oncology company, Imugene Limited (ASX:IMU), has achieved a major milestone in its Phase 1 MAST (metastatic advanced solid tumours) clinical trial, a study being conducted to measure the safety of VAXINIA, a City of Hope-developed cancer-killing virus, CF33-hNIS.
As per the latest release, 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 patients in IT cohort 1.
CRC reviews VAXINIA’s safety
The ASX-listed firm has received a review from the Cohort Review Committee (CRC) for VAXINIA. The CRC has regarded VAXINIA as safe, without any dose-limiting toxicities (DLTs). Also, no severe adverse reactions were observed when its dose was administered to the first three patients as part of monotherapy.
At the end of the review meeting, the CRC suggested Imugene continue with the opening of the second VAXINIA Phase 1 cohort at the mid-dose level.
Image Source: Company Announcement
An overview of Phase I Clinical Trial of VAXINIA
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).” Under this study, a total of 100 patients will be recruited for about 10 trial sites in the United States and Australia. It is expected that the trial will conclude in around two years.
The Phase 1 trial of the new Oncolytic Virus has been initiated with a low-dose administration of VAXINIA to patients having metastatic or advanced solid tumours with a minimum of two prior lines of standard of care treatment. In preclinical laboratory and animal models, it has been observed that VAXINIA shrinks colon, lung, breast, ovarian and pancreatic cancer tumours.
After acceptable safety is demonstrated in the patients treated with the lowest doses of VAXINIA, it will be administered to new study participants in combination with immunotherapy pembrolizumab. Most probably, this will start after cohort 2 gets cleared per route of administration.
Image Source: ©2022 Kalkine Media®, Data Source: Company Announcement