In April, Reneuron relocated its headquarters to Cardiff, Wales after leasing an R&D and manufacturing site set to be ready for production next year. As the facility becomes live, the reliance on third party manufacturers will be reduced, according to an N+1Singer initiation of coverage report.
“A manufacturing facility, funded by the Welsh government, is estimated to be complete in H1 2015 with Phase III supply from H1 2016,” the report said. “This will provide the group with greater control over its manufacturing capabilities and development timelines. We initiate coverage with a 6.2p price target and Buy recommendation.”
The new facility in the Pencoed Technology Park will comprise of almost 26,000sq ft of R&D space, as well as GMP cleanrooms which will contain robotic cell culture arms from TAP Biosystems – now a part of Sartorius. The cost of converting and fitting out the facility is being paid for by the Welsh Government.
ReN001, Reneuron’s lead candidate, is a potential treatment for stroke disability currently in Phase II clinical trials. The firm was using Angel Biotech for its clinical trial supplies, but the contract manufacturing organisation (CMO) went bankrupt in early 2013. In September 2013, Reneuron inked a deal for ReN001 to be produced at Roslin Cells’ facility in Edinburgh, Scotland.
CTX cell line technology
The analyst firm was also positive about Reneuron’s CTX stem cell line platform which is being used to develop ‘off‐the‐shelf’ stem cell treatments for large patient population diseases. The cell line is produced from a single tissue sample and offers a number of advantages over other stem cell technologies, according to Reneuron:
“[The CTX cell line] represents a standardised, clinical and commercial-grade cell therapy product capable of treating all eligible patients presenting with the diseases targeted, without the need for additional immunosuppressive drug treatments,” the firm says.
“There will be no need to re-derive and test new cell lines for subsequent clinical trials or for the market – all such cells can simply be expanded from the existing banked and tested product.”
Reneuron’s lead candidate is a potential treatment for stroke disability currently in Phase II clinical trials. So far studies have shown the CTX mechanism improves blood flow following a stroke producing a disease‐modifying effect.
There have been a number of investments and deals made in the stem cell space over the past few years, and according to a report from GlobalData, such therapies are on the cusp of breaking through into the mainstream drug market.
“The off the shelf systems developed by Reneuron are still in the early stages of development,” Aparna Krishnan - GlobalData’s Analyst covering Healthcare Industry Dynamics – told this publication. “However, if successful, they represent another area of opportunity for stem cell firms.”