Reneuron Regulatory News (RENE)

AIM: RENE 31 January 2019

ReNeuron Group plc

("ReNeuron" or the "Company")

New exosome production scale-up data presented

ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, is pleased to announce that new data relating to the manufacturing scale-up of its GMP produced, CTX-derived exosomes will be presented today at a leading US forum on the manufacture of cell and gene therapies.

Dr Nicola Goddard of the Department of Biochemical Engineering, University College London, will present new data from a grant-funded collaboration between ReNeuron, UCL and the Cell and Gene Therapy Catapult at the ECI Advancing Manufacture of Cell and Gene Therapies VI conference in Coronado, California. The new data demonstrate the feasibility of scaling up the production of ReNeuron's CTX-derived exosomes utilising state-of-the-art bioreactor systems, representing a significant advance towards an industrial scale production process without affecting the quality and consistency of the final product.

The ongoing collaboration is part-funded by a grant from Innovate UK, the UK's innovation agency.

Further information about the ECI conference can be found at http://www.engconf.org/scale-up-and-manufacturing-of-cell-based-therapies-vi/

Commenting on the new data, Dr Randolph Corteling, Head of Research at ReNeuron, said: "Exosomes are biological nanoparticles ideally suited to the delivery of oligonucleotide and gene-based therapies due to their natural occurrence and abundance, their ability to protect their cargo from degradation, and their potential for favourable bio-distribution. The ability to scale-up production of our CTX-derived exosomes, as demonstrated by these new results, further exemplifies the capability of ReNeuron's exosome platform." 

ENDS

About ReNeuron's Exosome Platform

ReNeuron has established an endogenous, high-yielding, CTX cell-line derived exosome platform that can be produced through a fully qualified, xeno-free, optimised scalable GMP process. Conditional immortalisation of the cell-line ensures consistent exosome product. The company has been able to successfully load miRNA and protein into its exosomes.

The CTX producer cell-line can also be modified to carry siRNA/mRNA/miRNA, CRISPR/Cas9, proteins, small-molecule inhibitors and engineered to target particular tissues.

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 disability as a result of stroke and for the blindness-causing disease, retinitis pigmentosa.

ReNeuron is also advancing its proprietary exosome technology platform as a potential delivery system for drugs that would otherwise be unable to reach their site of action.

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.