Purple Biotech has dosed the first participant in the randomised stage of the Phase II clinical trial of CM24 to treat advanced metastatic pancreatic cancer (PDAC).
The Phase II open label clinical trial is evaluating CM24, a new humanised monoclonal antibody that blocks immune checkpoint proteins and targets CEACAM1.
CEACAM1 supports tumour immune evasion and survival through several pathways.
It will include nearly 30 participants in the experimental cohort and an additional 30 subjects in the control cohort.
A total of ten participants have already been enrolled in the trial’s safety run-in segment, during which no dose-limiting toxicities (DLTs) have been observed so far.
Currently, the trial is being conducted in 11 sites in Israel, Spain, and the US.
The company expects to open nearly ten additional sites in the upcoming months.
In a randomised fashion, the trial is designed to compare the treatment with CM24 along with nivolumab, a PD-1 immune checkpoint inhibitor, and standard of care (SoC) chemotherapy, against SoC chemotherapy in second line PDAC patients.
Overall survival is the primary endpoint of the trail’s randomised stage.
Purple Biotech CEO Gil Efron said: “We are excited with the progress made in this study as we start its randomised part.
“Patients with metastatic pancreatic cancer such as those we are enrolling in our ongoing trial have very few therapeutic options, with relatively short duration of survival. If this study is successful, it may open a path for a short time to market.”
The company expects to share interim results from the trial in the second half of this year, with a topline report on the complete study by the end of next year.