Clinical stage immuno-oncology company Imugene (ASX:IMU) reports it has progressed to the next stage of its phase one Metastatic Advanced Solid Tumours (MAST) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA).
The company’s intravenous (IV) cohort 1 has now cleared, which has resulted in the opening of cohort 2 for IV administration and is expected to run for about 24 months on funding from existing budgets and resources.
The Cohort Review Committee (CRC) have once again unanimously agreed that VAXINIA is safe, with no dose-limiting toxicities (DLTs) and no serious adverse reactions were observed after the CRC review of all safety and tolerability data.
Data was gathered from the first 3 patients dosed intravenously with the lowest dose of VAXINIA as monotherapy.
“The MAST trial for VAXINIA has continued its positive momentum unimpeded to date”
Speaking on the progression of the study, Imugene Managing Director and CEO, Leslia Chong said: “The MAST trial for VAXINIA has continued its positive momentum unimpeded to date, and again this is credit to Imugene’s management. This momentum should be maintained with additional sites and broader patient recruitment as we move toward the new year.”
Imugene also notes that upon completion of the review meeting, the CRC advised the company to proceed with opening the second VAXINIA phase one IV cohort at the mid-dose level.
The next study participants within this next phase of the study are expected to receive VAXINIA in combination with the immunotherapy pembrolizumab,
In addition, the study aims to recruit up to 100 patients across 10 trial sites in the United States and Australia.
It is also reported that this announcement comes following the first patient being dosed as part of intratumoral (IT) cohort 2 of the trial, as announced by the company in October.
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 Pembolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST).”
Imugene is a clinical stage immuno-oncology company with a goal of developing a range of new treatments that seek to activate the immune system of cancer patients to identify and eradicate tumours. The company’s lead candidate to achieve this goal is a chimeric vaccinia (pox) virus known as CF33, which was developed by Professor Yuman Fong at the prestigious city of Hope Comprehensive Cancer Center in Los Angeles, California.
CF33 represents a genetically stable double stranded DNA virus of the Poxviridae family and has a track record of safe use in millions of humans, as it was the active constituent of the vaccine that eradicated smallpox.
With VAXINIA now entering the second stage of clinical trials, Imugene announces it remains focused on maintaining its positive momentum with additional sites and broader patient recruitment as it enters into the new year.