Press Releases

Cell therapy start-up set for the big time

(by Stuart Crayford, Bioventure View, 8th October 2003)

UK cell therapy company Intercytex will fly its incubator coop at the end of the year and move to a larger site five miles down the road. The Company is embarking on a clinical trial spree, and will need the extra space to cope with the manufacturing and scale-up of several products.

Intercytex is currently based in a bioincubator in Manchester, UK. Michael Leek, Commercial Director, told BVV that making the right location decision is essential. "If you get this wrong, it could be a company killer. Moving to the south-east may sound great as we could situate in a biotech cluster but a company can expect to lose perhaps a third of its overall workforce by relocating. Also all biotechs are keen to keep their burn rates to a minimum and in general, premises are less expensive in Manchester than Cambridge."

The Company is able to afford larger premises following the second closing of its series C fundraising in June this year, raising a total amount of £9 million. New investors were Scottish Equity Partners and NIF Ventures, who joined existing investors Avlar BioVentures, Cambridge Gateway, Johnson & Johnson Development, Merlin Ventures, 3i and Temasek. The Company has now raised a total of £17.5 million to date. "As our product portfolio matures, the IPO option will undoubtedly be considered," Leek added.

The reason for moving is primarily concerned with manufacturing its product candidates for clinical trials. At its current incubator site, Intercytex has only one clean room, whereas the new facility in Wythenshawe will have four. "The ability to make products to MHRA (the UK's Medicines and Healthcare products Regulatory Agency) and FDA standards is one of the core skills that sets us apart as a company, so we really need this additional manufacturing infrastructure," Leek explained.

The Company's lead product – ProtoDerm -is a treatment for chronic wound healing. It has already successfully completed Phase I/II trials, and a multi-site Phase II/III trial in the UK and Poland is set to begin next month, along with a Phase III trial in the US next year. "At this stage we have not partnered the product, although we have had some early interest. Our intention is to keep commercialisation options open, and define the marketing strategy when we have a better handle on both efficacy and cost to the end-user," said Leek.

Intercytex' second lead, TrichoCyte, relies on the injection of culture-expanded dermal papilla cells to induce new hair formation. A Phase la trial is planned in Manchester for late 2003, followed by a Phase II trial in the US. "TrichoCyte will be indicated initially as an adjunct to existing hair transplants, as current procedures are surgically demanding, require a significant amount of donor tissue and are very painful for the patient. Much of the early product development was performed at Intercytex’ laboratories in the US. Six months after forming the Company, we commissioned a facility in the Boston area. This has had several benefits - in particular allowing us to recruit key staff within the US. We were lucky to have a good set of VCs who understood that an early presence in the US would pay dividends," he commented.

One of the Company's earlier-stage products is aimed at treating end-stage renal disease by regenerating kidney tissue. The technology is based on the transplant of kidney precursor structures known as metanephroi, taken from pigs. "Although this programme is very technically demanding, we have made significant preclinical progress. Clinical trials for this type of kidney disease will be extremely expensive and time-consuming, so hopefully we will have either partnered the technology or will receive revenue from at least one of our leads before the approach is ready for the clinic," said Leek.

Intercytex' earliest programme is a stem cell technology, based on the use of cytoplasmic components to reprogramme adult somatic cells. Leek feels that it will be a long time before it reaches the clinic. "Until we can work out how to turn reprogrammed cells into functional tissue or organs, we can't put too much emphasis on this kind of technology. It's a very exciting platform, however it is much too early to be bullish about commercial implications."

ProtoDerm will be competing with wound-healing products from companies such as Organogenesis and Smith & Nephew. TrichoCyte, however, will not face direct competition. "There are currently no products like this on the market as most hair transplants are performed in private clinics throughout the US. The initial plan is to integrate TrichoCyte as a complementary therapy to surgery; however, with further development, TrichoCyte should become a stand alone alternative to conventional hair transplants," he said.

"Tissue engineered products have traditionally been very costly mainly because of complex manufacturing processes and the high cost of raw materials. One of our core aims is to produce products that are more cost-effective and efficacious than current cell-based technologies," Leek concluded.