Faron Pharmaceuticals (Faron), the clinical stage biopharmaceutical company, has signed an agreement with the University to initiate a liver cancer programme testing Clevegen, Faron’s immuno switch antibody, in clinical trials.
This exciting 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 the NIHR Birmingham Biomedical Research Centre (BRC), which was established on 1 April 2017.
Faron and the University anticipate filing the clinical trial application (CTA) with the UK regulatory authorities MHRA in late 2017 or early 2018. In the event of successful collaboration and CTA approval, it is expected that Faron and the University will conduct the TIETALC trial together.
The main focus of TIETALC is to study the safety, pharmacokinetics/pharmacodynamics and initial efficacy of Clevegen in liver cancer patients, focusing on those with hepatocellular carcinoma. 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.
Professor David Adams, Director of the NIHR Birmingham BRC and Head of the College of Medical and Dental Sciences at the University, 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 liver 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.’
Dr Markku Jalkanen, CEO of Faron, said: ‘We are excited to start this collaboration with this world-renowned liver cancer unit in Birmingham. Their substantial clinical expertise and numerous research programmes in liver cancer treatment will provide us with a unique opportunity to assess the effect Clevegen has on immune function in these patients.
‘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.’
Hepatocellular cellular carcinoma (HCC) is the most common liver cancer type and the leading cause of cancer-related morbidity and mortality worldwide. Less than 20% of HCC patients are alive five years post diagnosis and there is a clear unmet need for effective targeted therapies.
HCC is usually a complication of liver cirrhosis which may be caused by viruses, toxins (including alcohol) or autoimmune liver diseases. Additionally, the liver is a frequent site of metastasis from other cancers, particularly colorectal cancer. The immune positive phenotype of HCC and reports of responses to immunotherapy suggest that is an excellent target tumour for immuno-oncology treatments by the removal of immunosuppressive white blood cells including macrophages.