Faron Pharmaceuticals Ltd (LON: FARN) announced that Clinical Trial Application (CTA) to conduct a Phase I/II study with Clevegen, its wholly-owned novel precision cancer immunotherapy drug has been approved by the Finnish Medicines Agency (FIMEA).
The clinical stage biopharmaceutical company said that patient recruitment into the Phase I/II MATINS study is expected to commence shortly at Helsinki and Oulu University Hospitals in Finland, with Clevegen in development for the treatment of selected metastatic or inoperable tumours.
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The group added that same CTA is also under review by the UK's regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA) for opening sites in the UK - the Royal Marsden Hospital in London and the Queen Elizabeth Hospital in Birmingham.
Clevegen is a novel anti-Clever-1 antibody, which causes changes in the immune environment of solid tumours by switching Clever-1 positive immune suppressive macrophages to immune active macrophages.
Clever-1, a cell surface receptor expressed mainly by tumour vasculature and monocytes/macrophages, has been shown to control tumour growth, cell-mediated immunity, and to participate in the control of B cell response and antibody production.
Dr Markku Jalkanen, Faron’s chief executive officer said: "Approval of our CTA to conduct a Phase I/II study with Clevegen represents a significant milestone for the Company.
“Clevegen, our wholly-owned novel precision cancer immunotherapy drug, has already demonstrated promising pre-clinical results and provided human ex vivo data that supported earlier pre-clinical observations.”
He added: “We look forward to starting recruitment into the MATINS study soon and obtaining the first in vivo surrogate marker data from Clevegen treated patients during H1-2019."