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RNS Number : 7356P
Silence Therapeutics PLC
21 October 2021
Silence Therapeutics Provides mRNAi GOLD(TM) Platform and
Pipeline Updates at 2021 R&D Day
- Announces plans to initiate a Phase 1 study in polycythaemia
vera (PV) with SLN124, the third indication being assessed using
endogenous hepcidin modulation
- SLN360 single-ascending dose study on-track for topline data
in Q1'22 - independent review committee recommends extending
follow-up period to assess potential longer duration of action
- Advancing mRNAi GOLD(TM) platform programs - poised to deliver 2-3 INDs per year
from 2023
21 October 2021 , LONDON and NEW YORK -- Silence Therapeutics
plc (AIM: SLN and Nasdaq: SLN ), a leader in the discovery,
development and delivery of novel short interfering ribonucleic
acid (siRNA) therapeutics for the treatment of diseases with
significant unmet medical need , announces it is hosting its
R&D Day in New York City today.
During the event, Silence plans to showcase its proprietary
mRNAi GOLD(TM) platform and current clinical programs, including
SLN360 for cardiovascular disease due to high lipoprotein(a), or
Lp(a), and SLN124 for thalassemia and myelodysplastic syndrome
(MDS) as well as a newly added program in polycythemia vera (PV).
Silence will also provide an update on its growing discovery
pipeline and plans to deliver 2-3 INDs per year from 2023.
Mark Rothera, President and Chief Executive Officer of Silence
Therapeutics, said: "The vision at Silence has always been to build
an exquisite platform that would enable the development of
longer-lasting precision medicines to transform patients' lives. We
are pleased to report strong progress across both our proprietary
and partnered pipelines, including plans to further expand the
SLN124 program into a third indication, PV, where endogenous
hepcidin modulation can potentially improve outcomes for 3.5
million people worldwide who currently have very limited treatment
options. Through our hybrid business model, we are committed to
maximizing the substantial opportunity for our mRNAi GOLD(TM)
platform and remain well positioned to deliver 2-3 INDs per year
from 2023."
Giles Campion, MD, EVP, Head of R&D and Chief Medical
Officer of Silence Therapeutics, said: "We are very encouraged by
the outcomes from our recent safety review committee meeting for
SLN360. Based on their recommendations, we have now defined our
dose range and are ready to start the multiple-ascending dose
study. We are also extending the follow-up period in the
single-ascending dose study to fully characterize SLN360's duration
of action, which may be even longer than we initially anticipated.
We look forward to further evaluating SLN360 in the clinic and
remain on-track to report topline data in the single-ascending dose
study in the first quarter of 2022."
mRNAi GOLD(TM) Proprietary Program Updates
SLN124 Program
New highlighted updates include:
-- Plans to pursue new PV indication and start a phase 1 trial in the second half of 2022.
-- FDA acceptance of the US IND in myelodysplastic syndrome (MDS).
-- Enrollment continues in the two single-ascending dose studies
for thalassemia and MDS. Silence anticipates topline data from both
studies in the third quarter of 2022.
-- Positive results from the healthy volunteer study reported in
May 2021 accepted for poster presentation at the American Society
of Hematology (ASH) Annual Meeting being held December 11-14,
2021.
SLN360 Program
New highlighted updates include:
-- On-track to report top-line data in the single-ascending dose
study in the first quarter of 2022.
-- Key outcomes from the independent safety review committee meeting:
o Recommendation to extend follow-up period in the
single-ascending dose study from 150 days to 365 days to fully
assess the duration of action, which may be longer than initially
anticipated based on preclinical modelling.
o The therapeutic dose range has been established based on
Cohorts 1-4 (optional Cohort 5 not needed) and study can now
proceed to the multiple-ascending dose phase.
-- On-track to initiate phase 2 development in the second half
of 2022, pending regulatory discussions.
Building Proprietary Pipeline
-- Advancing two new undisclosed proprietary programs following
the Hansoh collaboration announced last week (read full release
here). Hansoh has the option to license China region rights at the
end of phase 1.
mRNAi GOLD(TM) Partnered Program Updates
AstraZeneca Collaboration for Cardiovascular, Renal, Metabolic
and Respiratory Diseases
-- Continuing work with AstraZeneca to develop siRNAs for two undisclosed targets.
-- On-track to initiate work on five targets within the first three years of the collaboration.
Mallinckrodt Collaboration for Complement-Mediated Diseases
-- Progressing IND-enabling studies for SLN501 C3-targeting
program and expect to initiate a phase 1 study in the first half of
2022.
-- Developing siRNAs for two other undisclosed complement-mediated disease targets.
Hansoh Collaboration
-- In addition to the two proprietary programs outlined above,
Silence will work with Hansoh on a third undisclosed program which
Hansoh has the option to license worldwide at the point of IND
filing.
-- As part of the Hansoh agreement, Hansoh made a $16 million
upfront cash payment and Silence has the potential for up to $1.3
billion in additional milestones plus royalties tiered from low
double-digit to mid-teens on Hansoh net product sales.
Targeting 2-3 INDs per year from 2023
-- Silence remains on-track to deliver 2-3 INDs per year from
2023 through both its proprietary and partnered mRNAi GOLD(TM)
platform programs. Key highlighted updates include:
o Expanded translational genomics efforts, contributing both to
finding new, genetically validated disease-causing genes and
continuously fine-tuning the siRNA design algorithm using machine
learning
o A fine-tuned drug discovery process
o Aiming for a mixed-risk portfolio of validated and novel
targets with projects at different stages of drug discovery
ensuring multiple shots on goal
The Company's R&D Day will be held today, October 21, 2021
from 9:00 am to 11:30 am ET at the Convene, 530 Fifth Avenue, in
New York City and will include a live video stream.
Webcast Link:
https://silence-therapeutics-rd-day.convene.com
Enquiries:
Silence Therapeutics plc Tel: +1 (646) 637-3208
Gem Hopkins, Head of IR and Corporate Communications
ir@silence-therapeutics.com
Investec Bank plc (Nominated Adviser and Broker) Tel: +44 (0) 20
Daniel Adams/Gary Clarence 7597 5970
European PR Tel: +44 (0) 20 3709
Consilium Strategic Communications 5700
Mary-Jane Elliott/Chris Welsh/Angela Gray
silencetherapeutics@consilium-comms.com
US Media Relations
MKC Strategies, LLC Tel: +1 (516) 606-6545
Mary Conway
MConway@MKCStrategies.com
About Silence Therapeutics
Silence Therapeutics is developing a new generation of medicines
by harnessing the body's natural mechanism of RNA interference, or
RNAi, to inhibit the expression of specific target genes thought to
play a role in the pathology of diseases with significant unmet
need. Silence's proprietary mRNAi GOLD(TM) platform can be used to
create siRNAs (short interfering RNAs) that precisely target and
silence disease-associated genes in the liver, which represents a
substantial opportunity. Silence's wholly owned product candidates
include SLN360 designed to address the high and prevalent unmet
medical need in reducing cardiovascular risk in people born with
high levels of lipoprotein(a) and SLN124 designed to address
iron-loading anemia conditions. Silence also maintains ongoing
research and development collaborations with AstraZeneca,
Mallinckrodt Pharmaceuticals, and Takeda, among others. For more
information, please visit
https://www.silence-therapeutics.com/.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking
statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 and other securities laws, including
with respect to the Company's clinical and commercial prospects and
the anticipated timing of data reports from the Company's clinical
trials. These forward-looking statements are not historical facts
but rather are based on the Company's current expectations,
estimates, and projections about its industry; its beliefs; and
assumptions. Words such as 'anticipates,' 'expects,' 'intends,'
'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions
are intended to identify forward-looking statements. These
statements are not guarantees of future performance and are subject
to known and unknown risks, uncertainties, and other factors, some
of which are beyond the Company's control, are difficult to
predict, and could cause actual results to differ materially from
those expressed or forecasted in the forward-looking statements,
including those risks identified in the Company's most recent
Admission Document and its amended Annual Report on Form 20-F filed
with the U.S. Securities and Exchange Commission on April 29, 2021.
The Company cautions security holders and prospective security
holders not to place undue reliance on these forward-looking
statements, which reflect the view of the Company only as of the
date of this announcement. The forward-looking statements made in
this announcement relate only to events as of the date on which the
statements are made. The Company will not undertake any obligation
to release publicly any revisions or updates to these
forward-looking statements to reflect events, circumstances, or
unanticipated events occurring after the date of this announcement
except as required by law or by any appropriate regulatory
authority.
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END
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