Arcadia Clinical Trial Results Published

18 August 2022

Cizzle Biotechnology Holdings Plc

("Cizzle Biotechnology", "Cizzle" or the "Company")

Arcadia Clinical Trial Results Published for Cizzle Biotechnology's Royalty Bearing interest in AZD1656

Cizzle Biotechnology, the UK-based diagnostics developer, is pleased to report that St George Street Capital ("SGSC") has announced the publication in Lancet eClinicalMedicine of the results of their Phase 2 clinical trial, ARCADIA.  The trial investigated AZD1656 for people with diabetes hospitalised with COVID-19.  As previously announced, Cizzle secured royalty sharing rights for the commercialisation of AZD1656 for COVID-19 and other indications, including inflammatory pulmonary and cardiovascular disease.

Highlights

·    Lancet eClinicalMedicine publishes results of ARCADIA Phase 2 clinical trial on AZD1656 for COVID-19 therapy

·    SGSC progressing commercial discussions with potential pharmaceutical partners to fund the additional clinical studies required and to bring AZD1656 to the market

·    Cizzle has a significant royalty bearing economic interest in AZD1656 for the treatment of COVID-19, and other diseases including inflammatory pulmonary and cardiovascular disease

eClinicalMedicine is an open access clinical journal published by The Lancet. It is an internationally trusted source of essential, early evidence in clinical research.  It has published a paper on the results of the ARCADIA clinical trial on the use of AZD1656 to treat COVID 19.  Patients in the AZD1656 arm were observed to have lower mortality; additionally, AZD1656 was shown to have immunomodulatory capability, as predicted.  The paper also details their sub-group analysis of patients considered to be at higher risk of worse COVID-19 outcomes, either with elevated Interleukin 6 (IL-6) or those with low Vitamin D status.  As surmised in the paper: "the evidence presented here suggests that specific activation of Tregs might suppress the inappropriate inflammation which is the prime cause of tissue damage in autoimmune disease."

The full eClinicalMedicine paper may be accessed here: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00334-0/fulltext.

SGSC continues to progress commercial discussions with potential pharmaceutical partners to fund additional clinical studies, in both Covid-19, and potentially in further indications, required to bring AZD1656 to the market with the aim of generating revenues through milestone and or royalty payments, or by the outright sale of AZD1656.

On 14 February 2022, Cizzle announced that it had entered into an agreement with Conduit Pharmaceuticals Limited ("Conduit"), the commercial partner of SGSC and SGSC itself, to acquire a 5% uncapped economic interest (after deductions) in the commercialisation of AZD1656, in addition to its previous rights, as announced on 20 September 2021, to royalties of up to £5m for the treatment of COVID-19 and other diseases such as inflammatory pulmonary and cardiovascular disease.

Allan Syms, Executive Chairman of Cizzle Biotechnology, said

"The publication of the ARCADIA trial in such a prestigious journal as Lancet eClinicalMedicine provides a high level of scrutiny to support the evidence that certain COVID-19 patients could benefit from treatment with AZD1656.  That it seems to be doing so by acting as an immunomodulator to dampen inflammatory response suggests it could have wider applications in managing serious cardiovascular and lung diseases. This aligns with our strategy of building a portfolio of early detection tests, companion diagnostics and royalty bearing stakes in significant drug assets and ultimately progress our ability to earn revenues through royalty sharing rights."

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About Cizzle Biotechnology

Cizzle Biotechnology is also developing a blood test for the early detection of lung cancer.  Cizzle Biotechnology is a spin- out from the University of York, founded in 2006 around the work of Professor Coverley and colleagues.  Its proof-of-concept prototype test is based on the ability to detect a stable plasma biomarker, a variant of CIZ1 known as CIZ1B.  CIZ1 is a naturally occurring cell nuclear protein involved in DNA replication, and the targeted CIZ1B variant is highly correlated with early-stage lung cancer.

For more information, please see https://cizzlebiotechnology.com

You can also follow the Company through its twitter account @CizzlePlc and on LinkedIn.

About SGSC

SGSC is a UK-based medical-charity led by a group of highly experienced academics and ex-pharma executives, that was formed to deliver much needed treatments to patients. SGSC's strategy is to take clinical-ready assets from pharmaceutical companies and to progress them through Phase II trials before licensing them on for Phase III trials and commercialisation, to create a return for investors and the charity alike

For more information please see St George St (sgscapital.org)

About AZD1656

AZD1656 was originally developed by AstraZeneca as a diabetes treatment and has an extensive record of safety in clinical studies involving more than one thousand subjects.  Preclinical data suggested a likely immune mode of action, leading SGSC to secure a licence to the agent as a therapy for inflammatory conditions.

In addition to the ARCADIA study supported by Excalibur Medicines Limited, the Mubadala Sovereign Wealth Fund, Chlodwig Enterprises and UKRI / Innovate UK, SGSC has actively built on the scope of AZD1656 through patent filing (COVID-19 combination treatment) and intends to exploit the beneficial immunomodulatory effect in immune dysfunction applications.

Excalibur Medicines Ltd (EML) is a subsidiary of Excalibur Healthcare Services, founded by leading scientific entrepreneur, Professor Sir Chris Evans, OBE. EML brought together the scientific intellectual property, international funding and a world leading team to take forward the ARCADIA trial.