Date: 2017-04-18
Type of information: Clinical research agreement
Compound: Clevegen®
Company: Faron Pharmaceuticals (Finland) University of Birmingham Medical School (UK)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism:
- monoclonal antibody. Clevegen® is an antibody designed to prevent tumour growth and metastasis which targets the tumour immune suppressor molecule, Clever-1. Clever-1 is an adhesion, scavenging and signaling molecule involved in cancer growth and is found in lymphatic and vascular endothelium as well as type 2 immunosuppressive macrophages. When Clever-1 is blocked, tumour-associated macrophages (TAM) cannot enter the tumour site and their function in the tumour as an immune suppressive cell is diminished. Both these events change the tumour environment from immune suppression to immune stimulation, allowing the host immune system to fight the tumour cells.
Disease: liver cancer
Details:
- • On April 18, 2017, Faron Pharmaceuticals announced that it has signed an agreement with the University of Birmingham Medical School to initiate a liver cancer program testing Clevegen®, the Company's immuno switch antibody, in clinical trials. 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.
- As part of the preparations, approval will be sought from the UK regulatory authorities (MHRA) for an adaptive protocol, which would allow flexible administration of Clevegen based on results obtained in previous dosings. Faron and the University of Birmingham anticipate filing the clinical trial application (CTA) with the MHRA in late 2017 or early 2018. In the event of successful collaboration and CTA approval, it is expected that Faron and the University of Birmingham 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 (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. This detection could potentially become a surrogate marker of improved immune capacity in response to Clevegen and assist in the selection of those target cancer patients who are likely to benefit most from Clevegn treatment.
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