Reneuron Regulatory News (RENE)

AIM: RENE 9 June 2016

ReNeuron Group plc

ReNeuron to pursue brain cancer as first clinical target for exosome nanomedicine platform

ReNeuron Group plc (the "Company") (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, is pleased to announce that it has selected glioblastoma multiforme ("GBM") as the first clinical target for its exosome nanomedicine platform, based on evidence of tumour-inhibiting activity from early pre-clinical studies with the technology.

GBM accounts for 16 per cent of all diagnosed brain cancers. Overall median survival for newly diagnosed disease is 12 to 15 months with 5 year survival rates of 4 to 6 per cent. The incidence rate in the US and Europe combined is around 25,000 patients per annum.

Exosomes are nanoparticles secreted from all cells including ReNeuron's proprietary CTX stem cell line. They play a key role in the transfer of beneficial proteins and particularly non-coding microRNAs ("miRNAs") from one cell to another. ReNeuron researchers have identified a unique mechanism by which exosomes expressed from CTX cells inhibit the growth and migration of glioblastoma cells in pre-clinical models of the disease. Earlier this year, a paper was published in the scientific journal PLOS ONE1 describing work undertaken by ReNeuron researchers to identify a unique set of highly enriched miRNAs contained within CTX-derived exosomes. The research demonstrated that these miRNAs may have significant impact in regulating cell growth and apoptosis in cancer.

Based upon these promising findings, ReNeuron is pursuing pre-clinical development of its selected exosome nanomedicine candidate, designated ExoPr0, targeting GBM. The Company is collaborating with the Netherlands Cancer Institute ("NKI") in order to further establish the efficacy of ExoPr0 in relevant pre-clinical models of the disease. NKI is one of Europe's most prestigious oncology research and clinical centres and has been at the forefront of some of the greatest recent breakthroughs in immuno-oncology. ReNeuron is also collaborating with the Cell and Gene Therapy Catapult and the Department of Biochemical Engineering at University College London under a recently awarded £2.1 million grant from Innovate UK. This grant will fund the development of robust manufacturing systems to enable the production of ExoPr0 at a commercial scale, as well as product characterisation work and pre-clinical efficacy and toxicity testing of the ExoPr0 candidate.

Assuming a successful outcome to the above pre-clinical development programme, the Company expects to be able to file an application to commence a first human clinical trial with ExoPr0 in the second half of next year.

Olav Hellebø, Chief Executive Officer of ReNeuron, said:

"ReNeuron is a global leader in the exciting new field of exosome therapeutics and the selection of our ExoPr0 therapeutic candidate, initially targeting glioblastoma, expands our therapeutic pipeline into oncology, a field with huge therapeutic and commercial potential. We are delighted to be working with such prestigious collaborators on this programme and we look forward to reporting further progress towards the clinic over the coming year."

1. Stevanato, L et al. Investigation of Content, Stoichiometry and Transfer of miRNA from Human Neural Stem Cell Line Derived Exosomes. PLOS ONE, doi 10.1371/journal.pone.0146353 (2016).

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About ReNeuron

ReNeuron is a leading, clinical-stage cell therapy development company. Based in the UK, its primary objective is the development of novel cell-based therapies targeting areas of significant unmet or poorly met medical need.

ReNeuron has used its unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered "off-the-shelf" to any eligible patient without the need for additional immunosuppressive drug treatments. The Company has therapeutic candidates in clinical development for motor disability as a result of stroke, for critical limb ischaemia and for the blindness-causing disease, retinitis pigmentosa.

ReNeuron is also advancing its proprietary exosome technology platform as a potential new nanomedicine targeting cancer and as a potential delivery system for gene therapy treatments.

ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. Further information on ReNeuron and its products can be found at www.reneuron.com.

This announcement contains forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of ReNeuron and certain of the plans and objectives of management of ReNeuron with respect thereto. These statements may generally, but not always, be identified by the use of words such as "should", "expects", "estimates", "believes" or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking statements involve risk and uncertainty because they reflect ReNeuron's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of factors could cause ReNeuron's actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements.