Cell therapy company raises £68m to go it alone down R&D path
This article was originally published in Scrip
UK cell therapy company ReNeuron has raised £68.4m to advance two of its pipeline programs to regulatory filing stages.
It said the capital would allow it to further develop its core cell-based therapeutic programs, specifically its stroke disability and retinitis pigmentosa (RP) cell therapy products.
The company's stroke therapy is currently in Phase II studies and will advance into a Phase III trial next year. A Phase I trial of the company's RP product will begin this year with the aim of launching a Phase II/III pivotal trial two years from now. ReNeuron plans to be able to file its products for regulatory approval by the end of 2018.
Olav Hellebø, CEO of ReNeuron, told Scrip his company had enough cash now to advance its programs on its own. He said, "The nice thing about this funding round is that we are in control of our own destiny and we can progress our pipeline without being forced to do a deal." He pointed out that having to strike a licensing deal early in development was an issue for start-up biotechs. "They can't afford to take the next steps themselves, so they have to give away rights too early and too cheaply."
ReNeuron's funding, raised via a conditional placing of 1.3 billion shares priced at 5p per share, saw investment from existing and new parties predominantly based in the UK.
Mr Hellebø said that receiving significant investment from UK venture capitalists was important. "We have seen a great boom in biotech funding and in data production in the US, but it hasn't quite happened in the UK yet. We might be a few years behind the States but I think there is an opportunity to replicate that boom in Europe and that would be great," Mr Hellebø said.
Cell therapy has seen something of a reboot in recent months. The ReNeuron CEO said this was likely because of solutions in the manufacturing processes. "Cell therapy is starting to get somewhere," he said. "It has a lot of promise but hasn't quite delivered yet. We spent a long time dealing with manufacturing. Trying to manufacture these cells well, so they are of a high quality and a good quantity, has been a struggle for the industry. However, most companies are solving that problem now to a certain degree, including us. For us one of the breakthroughs was that we were able to preserve our cells." Instead of having just eight hours of shelf-life ReNeuron's cells now have a three month shelf-life. "And we will keep building on that," Mr Hellebø said.
Manufacturing is a big deal for the company and ReNeuron is in the process of taking over a manufacturing site in Wales, UK. "The goal for us is not only to take the site over but to make it a real center of excellence for stem cell manufacturing," the firm's CEO said. "It's extremely important to us to have full control of manufacturing, to have it in our own hands."
a growing crowd?
ReNeuron's CEO believes that even as cell therapy becomes a hot R&D space again, his firm can stay differentiated. "There are not many companies dealing with the same indications that we are. The number of players in heart disease directly or looking at spinal conditions, that sort of thing, is much higher."
ReNeuron also has an immortalized cell line, meaning a neverending supply. "I am not aware of any other cell therapy competitors that have this," Mr Hellebø said. "We have one cell we are using and we have cloned it into billions and billions of cells. Now we never have to go back again, that is unique. The cell itself is unique too; no one else can ever have that same cell."
ReNeuron's other pipeline programs besides its cell therapy studies in stroke and RP include a new exosome nanomedicine program in oncology, which the company hopes to take into the clinic next yearm and a Phase I program in critical limb ischemia (CLI), which will progress into Phase II next year.
Mr Hellebø highlighted that while there have been a lot of single-arm studies testing cell therapies in various indications, these tests have been in relatively small patient groups.
"It's not really enough to prove that these products work. But what is happening now, and what we have the funding to do, is the delivery of controlled clinical data from significant patient numbers to really show if these products are going to make a difference to patients."