Faron Pharmaceuticals and the University of Birmingham Medical School, have signed an agreement to begin a liver cancer program for clinical testing of Faron’s immuno switch antibody Clevegen.
This collaboration will focus on trial and protocol design for a Phase I/II trial, TIETALC, (Tumour Immunity Enabling Technology Against Liver Cancer) in liver cancer patients at Birmingham Health Partners’ NIHR Clinical Research Facility and the Centre for Liver Research.
Faron and the University of Birmingham should fill the clinical trial application (CTA) with the from the UK regulatory authorities MHRA in late 2017 or early 2018.
Besides the main focus of TIETALC to study the efficacy of Clevegen in liver cancer patients with hepatocellular carcinoma (HCC), the study will also examine the efficacy of Clevegen in reducing the number of Clever-1 positive, immune suppressive myeloid cells, circulating in the blood and entering tumour tissue of cancer patients where they can suppress anti-cancer immunity.
TIETALC may also assist Faron with its aim to develop a liquid biopsy based on recognition of Clever-1 positive circulating myeloid cells.
Dr Markku Jalkanen, CEO of Faron, said: “We are optimistic that Clevegen will stimulate strong immune responses against the cancer, restricting tumour growth and metastasis, and thereby improving the long term survival of these patients, whose prognosis with current therapies is very poor.”
Prof. David Adams from the University of Birmingham, said: “We are very familiar with the Clever-1 target molecule. Previously, we have demonstrated that it controls the accumulation of immunosuppressive regulatory lymphocytes in the liver1 and we have also shown in previous studies that liver cancer can be treated by stimulating anti-tumour immunity. We are excited to move towards commencement of trials using Clevegen which we believe has the ability to boost immune responses against liver cancer through a novel mechanism. The current prognosis for liver cancer patients is very poor and so potential treatments, like Clevegen, offer new possibilities in fighting this aggressive and poorly responsive cancer.”