What the company does
Human retinal progenitor cells (hRPC)
Human retinal progenitor cells differentiate into components of the retina.
Reneuron has developed the ability to scale up the manufacturing of hRPCs using a patented low-oxygen cell expansion technology.
The hRPC cell therapy candidate is being evaluated in an ongoing phase I/IIa clinical trial in the US in subjects with a blindness-causing inherited retinal disease, retinitis pigmentosa (RP).
CTX cell therapy candidate is a treatment for patients left disabled by the effects of a stroke.
Reneuron’s product is 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.
Data from the Phase II PISCES trial indicated CTX therapy was safe and well-tolerated and produced clinically meaningful and sustained improvement in the level of disability and dependence as well as motor function.
Exosomes are nanoparticles, released by cells, and contain a number of active proteins and micro RNAs, which are short non-coding RNAs capable of regulating gene expression, that are believed to play a key role in cell-to-cell communication.
ExoPr0, Reneuron’s first CTX-derived exosome therapeutic candidate, has demonstrated potential as both a novel therapeutic candidate as well as a drug delivery vehicle
How it is doing
In September it began dosing in the US for the expanded phase IIa trial of its hRPC cell therapy for the degenerative eye condition retinitis pigmentosa (RP).
ReNeuron expects to present further data over the next 12 months and it believes it will be able to compile enough clinical evidence in that time to seek approval in the second half of next year for a single pivotal clinical trial.
The US Food & Drug Administration (FDA) has also given the hRPC treatment fast-track status, which means it may be eligible for accelerated approval.
What the boss says: Olav Hellebo, chief executive
“The decision we have recently taken to focus our in-house activities on our retinal disease and exosome-based programmes provides the company with significant near-term opportunities to deliver value-enhancing data and commercial partnerships.”
“Our stroke disability programme will continue through regional partnerships and we are pleased to be working with Fosun Pharma as our partner for China, following the signing of the exclusive licence agreement for both our CTX and hRPC programmes in that territory during the period.”
- On the CTX front, a Phase IIb trial, called PISCES III, is underway.
- The results from this trial are expected in the first half of 2021 because patient recruitment has been slower than anticipated due to the nature and complexity of the study.
- ReNeuron remains in negotiations with potential partners for all of its key programmes.