Heartcel is an immune-modulatory progenitor (iMP) cell therapeutic agent, made from somatic stem cells, for ischemic heart failure being developed by Cardiff, UK-based Cell Therapy Ltd (CTL).
The license agreement will see Daiichi Sankyo develop and market the product in Japan, while CTL will retain manufacturing responsibilities for clinical trials and commercialisation.
“iMP cells are uniquely engineered - i.e. not-naturally occurring - progenitor cells designed for cardiac and immuno-modulatory specificity,” CTL’s CEO Ajan Reginald told Biopharma-Reporter.com.
“The source material is peripheral blood or bone marrow from healthy volunteers modified by extensive multi-step iterative expansion and culture process,” and is thus allogeneic ‘off the shelf’ regenerative product, rather than made using a patient’s own cells (autologous).
Heartcel, set to enter Phase III clinical trials in Europe and the US, was developed using CTL’s tissue-specific cell generation platform technology.
While the manufacturing process of Heartcel and CTL’s other cell therapy candidates differ from that of other cell-based therapies such as monoclonal antibodies, Reginald was unable to disclose any further information about the process.
In other UK-based stem cell news, Oxford’s Oxstem has raised almost £17m for the development of its preclinical pipeline.
“We will identify small molecule drug candidates, which can programme adult stem and stem-like cells to repair and replace tissues affected by disease or injury,” said co-founder Steve Davies.
According to the company, current stem cell treatments focus on injection of cells into the body and are available only in hospitals with access to the specialist laboratory facilities needed to harvest, isolate and multiply stem cells.
“OxStem plans to reprogram stem and stem-like progenitor cells that already exist in the body with no need for cell transplantation procedures.”