REG - Sareum Holdings PLC - CTA application to MHRA and Corporate Update

Sareum HoldingsAnnouncement

28/07/2022 07:17

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RNS Number : 9953T  Sareum Holdings PLC  28 July 2022

Sareum Holdings PLC

("Sareum" or the "Company")

Sareum submits Clinical Trial Authorisation application to UK MHRA for
development of TYK2/JAK1 inhibitor SDC-1801 and provides an Operational Update

á    Clinical Trial Authorisation application for a Phase 1a/b clinical
trial with SDC-1801 submitted to the UK Medicines and Healthcare Products
Regulatory Agency

á    Sareum has made significant progress advancing SDC-1801 towards
clinical development and plans to initiate Phase 1 clinical trials in 2022,
with a study in psoriasis targeted for 2023

á    The Company continues to progress translational studies to support
its cancer immunotherapy candidate, SDC-1802

á    New EU patent granted (April 2022), protecting the SDC-1802 molecule
and pharmaceutical preparations as a therapeutic to treat T-cell acute
lymphoblastic leukaemia

á    Sareum had a cash position of approximately £4.3 million as at 30
June 2022

á    A presentation to investors will take place on 4 August 2022 at
10.00am via the Investor Meet Company platform. See below for registration
details.

 

Cambridge, UK, 28 July 2022 Ð Sareum Holdings plc (AIM: SAR), the specialist
drug development company, today announces that it has submitted an application
for a Clinical Trial Authorisation ("CTA") to the UK Medicines and Healthcare
Products Regulatory Agency ("MHRA") for the development of SDC-1801 as a
potential new therapeutic for a range of autoimmune diseases with a focus on
psoriasis.

Sareum also provides a broader update on operational activities and pipeline
progress.

OPERATIONAL HIGHLIGHTS - STRONG PIPELINE PROGRESS

SDC-1801 (autoimmune disease)

SDC-1801 is a TYK2/JAK1 inhibitor being developed as a potential new
therapeutic for a range of autoimmune diseases with an initial focus on
psoriasis, an autoimmune condition affecting the skin.

 

Preclinical development activities required to apply for the CTA have been
successfully concluded and, consistent with the Company's clinical development
plan, an application for a CTA has now been filed.

 

TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune
system and has strong clinical validation in psoriasis and psoriatic
arthritis. Psoriasis is an autoimmune dermatological condition affecting more
than 60 million adults worldwide, with a market size for potential treatments
worth more than US$30 billion. Sareum believes that TYK2/JAK1 inhibition
offers potential for increased efficacy in psoriasis, compared with existing
approved therapies.

 

Sareum, working alongside a specialist contract research organisation (CRO),
has designed a Phase 1a/b clinical trial with SDC-1801 in healthy subjects and
psoriasis patients. Subject to regulatory approval from MHRA, the Phase 1a
trial is planned to commence in Q4 2022 and will investigate the safety and
tolerability of an oral formulation of SDC-1801 in ascending doses
administered to healthy subjects. In addition, the trial will evaluate the
effect of SDC-1801 on certain biomarkers of autoimmune disease that could be
predictive of efficacy when tested in patients.

 

The Phase 1a part of the trial is expected to provide safety and dosing
information applicable for any future trials in patients with other autoimmune
diseases and the acute respiratory symptoms of viral infections, including
COVID-19, should the Company decide to progress such trials.

 

Provided satisfactory safety data is obtained from this initial study, and
subject to additional funding, a Phase 1b clinical study will commence in
psoriasis patients in 2023. The CRO conducting and managing the studies has
extensive experience in conducting trials in inflammatory diseases and will
recruit up to 120 subjects at a site in Manchester, UK.

 

Synthesis of SDC-1801 drug substance under GMP conditions has been completed
successfully, with a surplus of material for the planned Phase 1 clinical
trials. GMP-compliant manufacture of capsules of SDC-1801, intended for use in
the Phase 1 trial, is also complete, and the capsules are undergoing rigorous
quality control checks before delivery to the clinical unit.

SDC-1802 (cancer immunotherapy)

Sareum continues to work on the translational studies needed to define the
optimal cancer application prior to completing toxicology and manufacturing
studies.

In April 2022, the Company was granted a new patent, protecting the SDC-1802
molecule and pharmaceutical preparations thereof as a therapeutic to treat
T-cell acute lymphoblastic leukaemia (T-ALL Ð a cancer of a particular type
of white blood cell called a T lymphocyte) and other cancers that are
dependent on TYK2 kinase for survival.

Licensed Programme Ð SRA737: A Selective Chk1 inhibitor

As noted in April 2022, Sierra Oncology, Inc ("Sierra"), the licence holder
for SRA737 (a novel Chk1 inhibitor discovered and initially developed by
scientists at The Institute of Cancer Research in collaboration with Sareum,
and with funding from Sareum and Cancer Research UK, licensed to Sierra in
September 2016), has been acquired by GlaxoSmithKline plc ("GSK") for US$1.9
billion in cash. The transaction was completed on 1 July 2022, and we await an
update concerning GSK's plans in respect of SRA737.

FINANCIAL POSITION

Sareum had a cash position of approximately £4.3 million as at 30 June 2022
(cash of £5.6 million as at 31 December 2021).

Dr Tim Mitchell, CEO of Sareum, commented:

"The CTA application for SDC-1801 is an important milestone as we advance this
promising potential new therapeutic into the clinic.

"SDC-1801 is a TYK2/JAK1 inhibitor which we believe has significant potential
in autoimmune disease and we plan to explore this initially in psoriasis,
where we believe dual inhibition of both TYK2 and JAK1 has the potential to
offer superior efficacy compared to small molecules currently available and in
development inhibiting each of the targets individually.

 

"We have completed most of the preparatory work for the clinical trial and
have built a robust data package to support our ongoing partnering activities
for this asset. Subject to regulatory approval by MHRA, we look forward to
advancing SDC-1801 into clinical development."

Investor Presentation:

A presentation to the investment community by Chief Executive Tim Mitchell and
Chief Scientific Officer John Reader will take place on 4 August 2022 at
10.00am via the Investor Meet Company platform.

Existing and potential investors wishing to participate in the presentation
can register here
(https://www.investormeetcompany.com/sareum-holdings-plc/register-investor) .

Questions can be submitted before the event via the Investor Meet Company
dashboard or at any time via the live presentation via the "Ask a Question"
function. Responses from the Q&A session will be published at the earliest
opportunity on the IMC platform.

A copy of the presentation will be made available on the Company's website
following the presentation.

- Ends -

 

For further information, please contact:

 Sareum Holdings plc

 Tim Mitchell, CEO                                   01223 497700

 Strand Hanson Limited (Nominated Adviser)

 James Dance / James Bellman                         020 7409 3494

 Peel Hunt LLP (Joint Corporate Broker)

 James Steel                                         020 7418 8900

 Hybridan LLP (Joint Corporate Broker)

 Claire Noyce                                        020 3764 2341

 Consilium Strategic Communications (Financial PR)

 Jessica Hodgson / Davide Salvi / Stella Lempidaki   0203 709 5700

 

About Sareum

Sareum is a specialist drug development company delivering targeted small
molecule therapeutics to improve the treatment of cancer and autoimmune
diseases. The Company aims to generate value through licensing its candidates
to international pharmaceutical and biotechnology companies at the preclinical
or early clinical trials stage.

Sareum is advancing internal programmes focused on distinct dual tyrosine
kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors into clinical development
as potential new therapies for autoimmune diseases (with an initial focus on
psoriasis), respiratory symptoms arising from viral infections and cancer
immunotherapy. Sareum is also eligible to receive certain milestone payments
and future royalties on SRA737, a clinical-stage, oral, selective Checkpoint
kinase 1 (Chk1) inhibitor that targets cancer cell replication and DNA damage
repair mechanisms. SRA737 was licensed to Sierra Oncology, which was acquired
by GSK in June 2022.

Sareum Holdings plc is listed on the AIM market of the London Stock Exchange,
trading under the ticker SAR. For further information, please visit the
Company's website at www.sareum.com (http://www.sareum.com)

 

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