REG - ReNeuron Group plc - Strategic update

ReNeuronAnnouncement

18/01/2022 07:05

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RNS Number : 7434Y  ReNeuron Group plc  18 January 2022

ReNeuron Group plc

("ReNeuron" or the "Company")

 

Strategic update

 

Priority focus now on Exosome drug delivery technology & Partnerships

Ophthalmology assets to be out-licensed

 

ReNeuron Group plc (AIM: RENE), a UK-based leader in Stem Cell and Exosomes
Technologies, announces a strategic update following a review of the latest
data from the hRPC (human retinal progenitor cells) Phase 2a clinical trial
for retinitis pigmentosa (RP) and an assessment of the commercial potential
for its Exosome technology.

 

Following a recent meeting of its Scientific Advisory Board in relation to the
RP programme, and having considered the commercial implications for the
Company, the ReNeuron Board has today taken the strategic decision to focus
its research and development on its Exosome technology platform, where it
currently has seven ongoing collaborations with further potential partnerships
in discussion. Concurrently, the Company intends to out-license its RP
programme assets following completion of the current clinical data package. A
more detailed update on the RP clinical trial is provided further below.

 

The immediate cost savings will be re-directed towards an increased investment
in the Exosome platform and provide a cash runway until late Q2 2023.

 

Olav Hellebø, Chief Executive Officer, commented: "While it is disappointing
that the RP clinical data achieved so far has been inconclusive as to which
patients respond best to our hRPC therapeutic candidate, we believe that the
programme still offers promise. However, we believe this would be best further
investigated by a partner. We are very excited about the market opportunity in
Exosomes and importantly our tissue-for-tissue matching expertise that gives a
truly differentiated offering to partners. We believe our work in this area
offers the best returns for our shareholders and we are confident that we will
increase the number of partners programmes this year and are already in the
process of recruiting additional employees in this field."

 

Iain Ross, Chairman of ReNeuron, added: "This has been a tough decision, but
it is clear from the clinical data generated to date we cannot justify further
substantial investment in the RP programme and that its future is better
served in the hands of a third party. This decision allows us to increase our
resource and investment in our Exosome technology platform and create
increasing and sustainable shareholder value."

 

Detailed update on Ophthalmology programme (hRPC Phase 2a trial)

The Company's RP study uses a cryopreserved hRPC formulation delivered via a
subretinal injection. It enrols subjects with advanced RP with some remaining
central vision. The study initially treated 10 patients with a 1 million cell
administration (the "Initial Study") and was followed by an additional
extension segment of the study proposing to dose up to nine patients with a
higher level 2 million cell dose.

 

In the period to the end of December 2021 the Company can confirm that seven
of the nine subjects in the extension arm have now been treated with the 2
million cell dose, with other potential subjects planned prior to year-end
either unable to complete screening or found to be unsuitable upon screening.
Although there have been no serious adverse events (SAEs) attributed to the
drug itself, experience in treating the subjects at the 2 million cell dose
has shown that the surgical procedure required to deliver this higher dose
(which involves a greater volume and therefore greater surgical complexity)
has led to more surgical complications compared to that seen with the 1
million cell dose. The data collected for this patient population, which was
impacted by the SAEs and difficulty in deploying the 2 million cell dose, have
to date shown very limited evidence of efficacy and given the SAEs, a number
of patients saw a reduction in visual acuity in the treated eye.

 

Additionally, while data from the Initial Study showed at 12 months a mean 9.9
letter improvement versus baseline in ETDRS letter score (the standardised eye
chart used to measure visual acuity in clinical trials), analysis of the
24-month data, while inconclusive, does appear to show that efficacy wanes
after 12 months. Four out of nine patients still show a positive response
versus baseline at month 24.

 

The Board has reviewed its commercial strategy and the financial resources
needed to progress the RP programme. Even though certain patients did appear
to benefit from the treatment (in particular in the first 12 months), further
patients would need to be treated at the 1m dose to try to identify which
sub-populations are most likely to lead to a higher and longer lasting
response. To fully understand this the Company believes an additional phase 2
trial would be needed and the Board believes that the size of the additional
investment required from ReNeuron into this programme would not be in the best
interests of shareholders. The Board believes that it therefore would be
better to complete a data package on the programme and look to out-license the
programme to a third party.

 

Focus on Exosome drug delivery technology

The Company's proprietary cell lines produce a panel of distinct tissue
matched Exosome drug delivery candidate which have the potential to target a
variety of indications and tissue types. Exosomes produced by the Company's
proprietary stem cell lines or via its induced pluripotent stem cell (iPSC)
platform can be manufactured through a scalable process and loaded with a wide
variety of payloads, such as nucleic acids (including siRNA, mRNA and miRNA),
proteins (such as Cas9, antibodies and peptides) as well as small molecules.

 

Positive pre-clinical data has already provided proof-of-concept that
ReNeuron's novel Exosome drug delivery technology can effectively deliver
therapeutic proteins to the specific region of the brain affected by several
neurological diseases such as stroke, Parkinson's disease and Huntington's
disease. These studies have shown that ReNeuron's Exosome technology offers
higher stability, more targeted delivery, and an increase in potency,
therefore potentially solving the delivery issues that can be experienced with
therapeutic proteins, and the Board believes this will be of interest to major
pharmaceutical companies to aid in the treatment of a variety of neurological
diseases.

 

Having already seen strong progress with the Company's Exosome platform,
ReNeuron is adding additional scientists in the next two months to focus on
this growth area.

 

 

 

Contacts:

 

 ReNeuron                                                 www.reneuron.com/investors (http://www.reneuron.com/investors)
 Iain Ross, Chairman
 Olav Hellebø, Chief Executive Officer                    Via Walbrook PR
 Catherine Isted, Chief Financial Officer

 Stifel Nicolaus Europe Limited (NOMAD and Joint Broker)  +44 (0)20 7710 7600

 Ben Maddison, Stewart Wallace

 Allenby Capital Limited (Joint Broker)                   +44 (0)20 3328 5656
 James Reeve/George Payne (Corporate Finance)
 Stefano Aquilino (Sales & Corporate Broking)

 Walbrook PR (Media & Investor Relations)                 +44 (0)20 7933 8780 or reneuron@walbrookpr.com
 Paul McManus/Alice Woodings                              +44 (0)7980 541 893 / +44 (0)7407 804 654

 

 

About ReNeuron

 

ReNeuron is a UK based Proprietary Stem Cell based Exosome Technologies
company, harnessing its unique stem cell technologies to develop 'off the
shelf' treatments for disease with significant unmet needs.

 

ReNeuron's stem cell derived proprietary Exosome Technology platform offers a
delivery mechanism for a variety of payloads such as siRNA, mRNA, proteins,
small molecules and genes. The Company has a growing number of partner
collaborations with Global Pharma, Biotech and academic partners in this
fast-expanding area of scientific and commercial interest. ReNeuron also has
the ability through its conditionally immortalised induced pluripotent stem
cell (iPSC) platform to make allogeneic tissue cells of choice and has the
potential to produce exosomes with tissue specific targeting ability.

 

The Company also has a Phase 2 cell therapy candidate in retinitis pigmentosa
which it plans to out-license and also has out-licensed its CTX programme in
stroke disability to Fosun in China.

 

ReNeuron's shares are traded on the London AIM market under the symbol
RENE.L.  For further information visit www.reneuron.com
(http://www.reneuron.com)

 

This announcement contains inside information. The person responsible for
arranging for the release of this announcement on behalf of the Company is
Catherine Isted, Chief Financial Officer.

 

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