REG - Syncona Limited - SwanBio Provides Clinical and Financing Update

SynconaAnnouncement

04/10/2023 12:15

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RNS Number : 6852O  Syncona Limited  04 October 2023

Syncona Limited

 

SwanBio Provides Clinical and Financing Update

 

 

04 October 2023

 

Syncona Ltd, a leading healthcare company focused on creating, building and
scaling global leaders in life science, notes that its portfolio company,
SwanBio Therapeutics ("SwanBio"), has provided a clinical and financing
update.

 

Highlights include:

 

·      SwanBio has begun the second dose-escalation cohort of its
clinical trial, PROPEL

·      PROPEL is a phase I/II first-in-human clinical trial assessing
the safety and efficacy of SBT101, an investigational gene therapy for
adrenomyeloneuropathy (AMN)

·      Dosing of SBT101, SwanBio's lead programme, was successfully
completed for the initial low-dose cohort with the therapy being well
tolerated and no serious adverse events related to SBT101 nor the
administration procedure reported to date

·      Following the review of this initial safety data readout in
August, an independent Data Safety Monitoring Board (DSMB) recommended
progressing the study to the higher-dose cohort, and the first patient in this
cohort has now received SBT101

·      Syncona will provide an additional $10 million (£8.2 million)
commitment 1  to SwanBio for it to complete dosing of the higher-dose cohort;
the company continues to work on its financing options

·      Following this investment, Syncona's holding in SwanBio is valued
at £77.1 million 2 

 

Chris Hollowood, CEO of Syncona Investment Management Limited, said:
"Following a review of the patient data from the first cohort, we are
encouraged that the DSMB has recommended the initiation of the higher-dose
cohort and we look forward to seeing the data generated from this cohort. Our
further investment of $10m will enable the company to deliver additional data
to deliver its long-term potential."

 

The announcement can be accessed on SwanBio's website at
https://swanbiotx.com/investors-and-media/
(https://swanbiotx.com/investors-and-media/) and the full text of the
announcement from SwanBio is contained below.

 

 ENDS 

 

Enquiries

 

Syncona Ltd

Annabel Clark

Tel: +44 (0) 7880724159

 

FTI Consulting

Ben Atwell / Natalie Garland-Collins / Tim Stamper

Tel: +44 (0) 20 3727 1000

 

About Syncona

 

Syncona's purpose is to invest to extend and enhance human life. We do this by
creating and building companies to deliver transformational treatments to
patients in areas of high unmet need.

 

Our strategy is to create, build and scale companies around exceptional
science to create a diversified portfolio of 20-25 globally leading healthcare
businesses, across development stage and therapeutic areas, for the benefit of
all our stakeholders. We focus on developing treatments for patients by
working in close partnership with world-class academic founders and management
teams. Our balance sheet underpins our strategy enabling us to take a
long-term view as we look to improve the lives of patients with no or poor
treatment options, build sustainable life science companies and deliver strong
risk-adjusted returns to shareholders.

 

Copies of this press release and other corporate information can be found on
the company website at: www.synconaltd.com Forward-looking statements - this
announcement contains certain forward-looking statements with respect to the
portfolio of investments of Syncona Limited. These statements and forecasts
involve risk and uncertainty because they relate to events and depend upon
circumstances that may or may not occur in the future. There are a number of
factors that could cause actual results or developments to differ materially
from those expressed or implied by these forward-looking statements. In
particular, many companies in the Syncona Limited portfolio are conducting
scientific research and clinical trials where the outcome is inherently
uncertain and there is significant risk of negative results or adverse events
arising. In addition, many companies in the Syncona Limited portfolio have yet
to commercialise a product and their ability to do so may be affected by
operational, commercial and other risks.

 

 

SwanBio Advances to Higher-Dose Cohort in First-in-Human Study of Gene Therapy
for Adrenomyeloneuropathy

 

Independent Data Safety Monitoring Board (DSMB) recommended dose escalation

 

First patient in cohort 2 has received SBT101

 

Majority investor Syncona providing new financing for further clinical
development

 

PHILADELPHIA, 04 October, 2023 - SwanBio Therapeutics (https://swanbiotx.com/)
, a gene therapy company developing AAV-based therapies for the treatment of
devastating, inherited neurological conditions, today announced it has begun
the second dose-escalation cohort of its first interventional clinical study,
PROPEL. PROPEL is a Phase 1/2 first-in-human clinical trial assessing the
safety and efficacy of SBT101, an investigational gene therapy designed to
compensate for the ABCD1 mutation that causes adrenomyeloneuropathy (AMN).

 

An independent Data Safety Monitoring Board (DSMB) recommended progressing the
study to the higher-dose cohort following the review of the initial safety
data readout in August. Patients in the first cohort received a single
intrathecal administration of the lower of two planned doses and were assessed
for treatment safety and tolerability. Dosing procedures were completed
successfully. No serious adverse events related to the procedure, nor the gene
therapy product, have been reported to date.

 

"We're proud to share that our lead candidate - the only gene therapy in
clinical development for the treatment of AMN - has been successfully
administered to and well-tolerated by men living with this devastating
disease," said David Weiner, chief medical officer, SwanBio. "Today's
milestone of progressing to our second cohort takes us one step closer to our
goal of bringing a safe and therapeutically meaningful drug to men and
families impacted by this disease."

 

Lead investor and majority shareholder, Syncona, Ltd. has made an additional
$10 million commitment to fund the second cohort of PROPEL.

 

"Following a review of the patient data from the first cohort, we are
encouraged that the DSMB has recommended the initiation of the higher-dose
cohort and we look forward to seeing the data generated from this cohort,"
said Chris Hollowood, CEO of Syncona Investment Management Limited. "Our
further investment of $10m will enable the company to deliver additional data
to deliver its long-term potential."

 

Currently active in the United States, PROPEL is expanding into Europe
following the recent approval of its Clinical Trial Application (CTA) from the
Central Committee on Research Involving Human Subjects (CCMO) in the
Netherlands. SwanBio is already active in Europe with multiple clinical sites
participating in CYGNET, a five-year natural history study in men with AMN,
that completed enrollment in 2022.

 

SwanBio's PROPEL study leverages learnings from CYGNET (NCT05008874), which is
piloting the use of wearable technologies to reduce onsite patient visits and
is exploring more efficient ways to capture disease progression.

 

Visit the SwanBio website for more information about PROPEL
(https://swanbiotx.com/pdfs/PPL_Patient%20Enrollment%20Flyer_FINAL.pdf)
(NCT05394064), which is actively recruiting patients.

 

About SBT101

SBT101 is the first clinical-stage adeno-associated virus (AAV)-based gene
therapy candidate for people with adrenomyeloneuropathy (AMN). In preclinical
studies, treatment with SBT101 demonstrated dose-dependent improvement of
disease markers and functional improvement in AMN mouse models. SBT101 was
also shown to be well-tolerated and persistent in non-human primates through
twelve months post-treatment. The clinical program for SBT101 builds on this
positive preclinical data, in addition to SwanBio's deep understanding of the
underlying pathophysiology of AMN and the AMN patient experience, including
new insights being gathered in the ongoing, proprietary natural history study,
CYGNET.

 

SBT101 has been granted Fast Track and Orphan Drug Designation from the U.S.
Food and Drug Administration and Orphan Drug Designation from the European
Medicines Agency.

 

About Adrenomyeloneuropathy

Adrenomyeloneuropathy (AMN) is a progressive and debilitating
neurodegenerative disease caused by mutations in the ABCD1 gene that disrupt
the function of spinal cord cells and other tissues. AMN is characterized by
loss of mobility in adulthood, incontinence, pain, and sexual dysfunction,
which all affect quality of life. Patients often experience adrenal gland
dysfunction as well. Between 8,000-10,000 men in the United States and EU5
(France, Germany, Italy, Spain, and the United Kingdom) are living with AMN.
There are no approved therapies for the treatment of the disease; current
standard of care is limited to symptom management.

 

About SwanBio Therapeutics

SwanBio Therapeutics is a gene therapy company that aims to bring
life-changing treatments to people with devastating, inherited neurological
conditions. SwanBio's initial focus is on gene therapies designed to be
delivered intrathecally to address targets within both the central and
peripheral nervous systems. This approach has the potential to be applied
broadly across three disease classifications - spastic paraplegias, monogenic
neuropathies, and polygenic neuropathies. SwanBio is supported by long-term,
committed investment partners, including its primary investors Syncona, Ltd.
(lead investor and majority shareholder) and Mass General Brigham Ventures.
For more information, visit SwanBioTx.com.

 

 

Media Contact:

Lara Furst

+1-703-946-0183

media@swanbiotx.com (mailto:media@swanbiotx.com)

 

Investor Contact:

Jan Case

investors@swanbiotx.com (mailto:investors@swanbiotx.com)

 1  Included in total deployment figure of £58.6m as at 28 September

 2  Valued at adjusted cost

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