Covid-19 Research Grant Confirmed

SAREUM HOLDINGS PLC

("Sareum" or "the Company")

Sareum Formally Awarded Grant Funding from the UK Government (UKRI) to Explore Potential of SDC-1801, a Selective TYK2/JAK1 Inhibitor, to Treat Covid-19

Cambridge, UK, 3 December 2020 - Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases, is pleased to announce that, further to the Company's announcement on 27 October 2020, the Grant Offer Letter from UK Research & Innovation ("UKRI") has been received and approved. This confirms Sareum's successful application for approximately £174,000 in grant funding (the "Grant") to investigate the therapeutic potential of SDC-1801, its selective, small molecule TYK2/JAK1 kinase inhibitor, in severe-phase Covid-19.

The Grant has been awarded to Sareum through the Innovate UK Sustainable Innovation Fund for projects that address and mitigate the health, social, cultural and environmental impacts of the Covid-19 outbreak. Under the conditions of the Grant, Sareum will contribute an additional c.£64,000 in cash as well as commit additional management time to the project, which is expected to take approximately six months to complete.

The aim of Sareum's Covid-19 research programme is to investigate the effects of SDC-1801 on cytokine signalling after human cells are infected with SARS-CoV-2, to confirm whether an over-active inflammatory response (known as a 'cytokine storm') via the Interferon Type 1 pathway can be blocked in this disease. The Company will also investigate whether treatment with SDC-1801 in disease models can re-establish protection against bacterial pneumonia following SARS-CoV-2 infection.

If this research and the ongoing preclinical development of SDC-1801 is successful, and subject to further funding, Sareum would aim to begin a clinical trial of SDC-1801 in severe-phase Covid-19 patients during 2021.

Overview of SDC-1801 and rationale for development in Covid-19

SDC-1801 was designed by Sareum to be a potent and selective dual inhibitor of tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1), which are part of the JAK family of proteins. These are important in cytokine-mediated cell signalling, which is a key component of the inflammatory response seen in autoimmune diseases and potentially the cytokine-release syndrome (CRS) associated with severe Covid-19. JAK inhibition, therefore, presents an attractive therapeutic strategy for CRS, which is a common cause of adverse clinical outcomes in Covid-19 and other viral infections.

SDC-1801 has demonstrated a potent anti-inflammatory effect in multiple disease models and is currently in preclinical development with the potential to become a new therapeutic targeting a wide range of inflammatory diseases, such as psoriasis, systemic lupus erythematosus (SLE) and Crohn's disease. It has demonstrated an encouraging safety profile in initial toxicity studies.

Covid-19 is caused by the virus SARS-CoV-2 and usually results in a mild disease that resolves on its own. However, some patients develop a potentially fatal severe disease due to inflammation arising from an overreaction of the immune system, known as CRS or a 'cytokine storm', leading to Acute Respiratory Distress Syndrome (ARDS), requiring intensive care. A major inflammatory pathway mediated by TYK2/JAK1 - the Interferon Type 1 pathway (Type 1 IFN) - is over-activated in severe Covid-19 patients and this pathway may be able to be blocked by SDC-1801.

Recently, researchers have observed the similarity between severe Covid-19 and the acute flares of lupus, an autoimmune disease characterised by overproduction of Type I IFN¹. As Sareum reported in July 2020, SDC-1802, a close analogue of SDC-1801, demonstrated encouraging results in a disease model of lupus. The Company believes that SDC-1801 could potentially benefit severe-phase Covid-19 patients by blocking signalling along this inflammatory pathway and therefore reducing the 'cytokine storm'.

Furthermore, disease model studies have reported that specifically inhibiting TYK2 activity restores the body's ability to protect against bacterial pneumonia following influenza infection², suggesting that a TYK2 inhibitor, such as SDC-1801, may have the same effect in Covid-19 patients. Serious bacterial infections have been reported in up to 50% of critically ill Covid-19 patients.

Positive results in its Covid-19 studies might lead to further opportunities for the Company to investigate SDC-1801 in treating severe and life-threatening inflammation that occurs as a result of other viral infections.

Sareum's CSO, Dr John Reader, commented:

"We are delighted that UKRI has now confirmed the grant funding to support our new studies to investigate the therapeutic potential of SDC-1801, our proprietary TYK2/JAK1 inhibitor, in severe-phase Covid-19. Alongside vaccines, there is a pressing need for new therapies to treat severe respiratory inflammation arising from viral infections such as Covid-19 and compelling scientific evidence to show that TYK2/JAK1 signalling may play an important role in the inflammatory cascade that leads to the cytokine storm observed in some patients. We will now move with all speed to begin our studies under this grant, which if successful - and also considering the safety/toxicity and other data from the formal preclinical studies - could enable us to advance this novel candidate into clinical development in severe Covid-19 patents during 2021."

In a UK Government press release regarding the grant fund*, Business Secretary, the Rt Hon Alok Sharma MP, said:

"The UK's response to coronavirus has demonstrated the very best of British ingenuity, and it is this resourcefulness that will help us navigate our way through this pandemic."

And in the same announcement, Innovate UK Executive Chair, Dr Ian Campbell, said:

"In these difficult times we have seen the best of British business innovation. The pandemic is not just a health emergency but one that impacts society and the economy.

"Every initiative Innovate UK has supported here is an important step forward in driving sustainable economic development. Each one is also helping to realise the ambitions of hard-working people."

*https://www.gov.uk/government/news/134-million-boost-to-help-uk-businesses-build-back-greener 

This announcement contains inside information for the purposes of Article 7 of Regulation 596/2014.

References 

¹ Woodruff M, et al. Critically ill SARS-CoV-2 patients display lupus-like hallmarks of extrafollicular B cell activation. medRxiv [Preprint]. (2020) May 3:2020.04.29.20083717. doi: 10.1101/2020.04.29.20083717. PMID: 32511635; PMCID: PMC7276991.

² Berg J, et al. Tyk2 as a target for immune regulation in human viral/bacterial pneumonia. Eur. Respir. J. 2017; 50: 1601953 https://doi.org/10.1183/13993003.01953-2016.

For further information, please contact: 

Sareum Holdings plc

Tim Mitchell, CEO                                                          01223 497 700

Strand Hanson Limited (Nominated Adviser)

James Dance / Richard Tulloch                                   020 7409 3494

Hybridan LLP (Nominated Broker)

Claire Noyce / John Beresford-Peirse                         020 3764 2341

Citigate Dewe Rogerson (Financial PR)

Mark Swallow / David Dible                                         020 7638 9571

About the Sustainable Innovation Fund

The Sustainable Innovation Fund, delivered through Innovate UK, is a cornerstone of the £1.25 billion investment package announced by the Chancellor in April 2020 to help ambitious, innovative businesses survive and thrive during the current pandemic. The investment forms part of the government's commitment to support the UK's entrepreneurs and start-ups to scale up their innovations, set out in its ambitious R&D Roadmap in July this year.

Nearly 1,200 companies across the UK will share £134 million of new Innovate UK investment through its latest dedicated COVID-19 innovation recovery fund. The £134 million funding comes from Innovate UK's Sustainable innovation Fund, which was launched as part of the £550 million package of measures to support innovative SMEs responding to COVID-19.

Each successful company will receive up to £175,000 to accelerate commercial production of their innovative products and services.

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 through preclinical development as therapies for autoimmune diseases, including the 'cytokine storm' immune system overreaction to Covid-19 and other viral infections, (SDC-1801) and cancer immunotherapy (SDC-1802).

The Company's preclinical FLT3+Aurora inhibitor programme targeting haematological cancers is licensed to a China-based specialty pharma company.

Sareum also has an economic interest in SRA737, a clinical-stage oral, selective Checkpoint kinase 1 (Chk1) inhibitor that targets cancer cell replication and DNA damage repair mechanisms. Preliminary Phase 2 and comprehensive preclinical data suggest SRA737 may have broad application in combination with other oncology and immune-oncology drugs in genetically defined patients.

SRA737 was 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. SRA737 was licensed by CRT Pioneer Fund (CPF) to Sierra Oncology Inc. Sierra is currently exploring options to obtain the funding or support necessary to advance the future development of SRA737.

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.

About UKRI

UK Research and Innovation works in partnership with universities, research organisations, businesses, charities, and government to create the best possible environment for research and innovation to flourish. The UKRI aims to maximise the contribution of each of its component parts, working individually and collectively. The UKRI works with its many partners to benefit everyone through knowledge, talent and ideas.

Operating across the whole of the UK with a combined budget of more than £8 billion, UK Research and Innovation brings together the seven research councils, Innovate UK and Research England.

For further information, please visit UKRI's website at www.ukri.org.