Cizzle Biotech Regulatory News (CIZ)

7 March 2022

Cizzle Biotechnology Holdings Plc

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

Further positive outcomes from the Arcadia Clinical Trial by SGSC and Excalibur Medicines 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 provided an update on the further analysis of data from the ARCADIA clinical study, which confirms the potential value of AZD1656 treatment for COVID-19 patients. According to SGSC, in addition to the clinical benefit observed, the immunological data strongly support its rationale that AZD1656 is an immunomodulator which damps down the inflammatory response characteristic of COVID-19 infection, while enhancing the part of the immune response that helps fight the virus.

Highlights

· SGSC announces an important update on the positive outcome of the Arcadia COVID-19 therapy trial of AZD1656

· SGSC is actively engaged in commercial discussions with appropriate global and regional pharmaceutical companies

· Cizzle has built a significant royalty bearing Economic Interest in AZD1656 for the treatment of COVID-19 and other diseases such as Inflammatory pulmonary and cardiovascular disease

· The SGSC update supports the Company's ambitions to expand into the pharmaceutical industry and is in line with its strategy of building a portfolio of early cancer detection tests, companion diagnostics and royalty bearing stakes in related drug assets

As previously announced, Cizzle has secured royalty sharing rights for the commercialisation of AZD1656 for COVID-19 and other indications, including inflammatory pulmonary and cardiovascular disease.

On 14 February 2022, Cizzle announced that it had entered into an agreement with Conduit Pharmaceuticals Limited ("Conduit") and SGSC 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 (the "Economic Interest").

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.

SGSC and Conduit are actively engaged in commercial discussions with appropriate global and regional pharmaceutical companies, with the objective of outright sale, partnership in future development or securing funding for the additional clinical studies necessary to get AZD1656 to market and patients. These opportunities are for AZD1656 in both Covid-19, and potentially in further indications. Conduit is the exclusive funding partner to SGSC.

Allan Syms, Executive Chairman of Cizzle Biotechnology, said

"The announcement today by SGSC is important because it provides further strong evidence that AZD1656 is a potentially valuable treatment for certain COVID-19 patients and that it seems to be providing benefit by acting as an immunomodulator, which damps down the inflammatory response. This should support SGSC's and Conduit's commercial ambitions to secure agreements with appropriate pharmaceutical companies, which should ultimately yield revenues for Cizzle through our royalty sharing rights.

"SGSC has also shown a role for AZD1656 in controlling Regulatory T Cells ("Tregs") which may be important in managing serious cardiovascular and lung diseases, and which are linked with the development of lung cancer. This enhances the Company's ambitions to expand its target customer base in the pharmaceutical industry through a strategy of building a portfolio of early cancer detection tests, companion diagnostics and royalty bearing stakes in significant drug assets." 

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About Cizzle Biotechnology

Cizzle Biotechnology is 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 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.