Cizzle Biotech Regulatory News (CIZ)

22 July 2021

Cizzle Biotechnology Holdings Plc

("Cizzle Biotechnology" or the "Company")

Collaboration with FairJourney Biologics to Develop Proprietary Antibodies for Early Lung Cancer Detection Tests

Cizzle Biotechnology, the UK based developer of a blood test for the early detection of a majority of the different forms of lung cancer, is pleased to announce the signing of a collaboration with FairJourney Biologics for the development and supply of proprietary key monoclonal antibodies that are the foundation for developing an enzyme-linked immunosorbent assay ("ELISA"), together with appropriate core reagents which are important requirements in the Company's roadmap for the commercial development of the Company's prototype CIZ1B biomarker test.

The Company's strategy, as outlined in its prospectus published in May 2021, is to develop Cizzle Biotechnology's prototype CIZ1B biomarker test into a commercial, CE marked and/or FDA 510(k) cleared diagnostic immunoassay that can be readily performed as a sufficiently reliable test in a hospital setting.

In order to pursue this goal, the Directors believe that Cizzle Biotechnology's testing methodology needs to be such that it can be deployed in a standardised sensitive and specific format for potential use in hospital laboratories. To achieve this, one approach is to take the current prototype ELISA assay developed by Cizzle Biotechnology and update it so that it can be performed using a monoclonal antibody or other detector proteins which may meet the requirements of regulatory bodies to bring the test to market. This requires that Cizzle Biotechnology work with a leading manufacturer such as FairJourney Biologics to produce the antibodies and reagents that may be used to validate its test format in clinical trials.

FairJourney Biologics, headquartered in Porto, Portugal, is a leading biologics clinical research organisation ("CRO"), providing integrated services across antibody discovery, engineering and production to global biopharma companies. They have successfully completed more than 500 projects with over 100 biotechnology and pharmaceutical companies. FairJourney Biologics merged with Cambridge, UK, based IONTAS in 2020 which was founded by John McCafferty, the co-discoverer of antibody phage display for which Professor Sir Greg Winter was awarded the Nobel prize for Chemistry in 2018. Earlier this year FairJourney Biologics opened a new purpose-built state of the art facility to carry out the type of key development activities that will be central to the programme for Cizzle Biotechnology.

Commenting, Allan Syms, Executive Chairman of Cizzle Biotechnology, said: "I am delighted that we have contracted with FairJourney Biologics to develop and supply the monoclonal antibodies and reagents required for our ELISA assay and future diagnostic platforms and tests. FairJourney Biologics is a recognised leader in its field and will be an important partner in our strategy to commercialise as quickly as possible our CIZ1B biomarker test for the early-stage detection of lung cancer.

"Since the admission of Cizzle Biotechnology to trading on the London Stock Exchange in May we are already making significant progress and I look forward to providing further updates in due course."

Commenting, António Parada, Chief Executive Officer of FairJourney Biologics, said: "We are excited to collaborate with Cizzle Biotechnology in discovering novel antibodies to be used as promising diagnostic tools. We believe that innovative diagnostic platforms such as the CIZ1B biomarker test will be a major step to hinder the progression of lung cancer and improve patient's prognosis in the long-term."

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About the Company

Cizzle Biotechnology is developing a blood test for the early detection of a majority of the different forms 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 Fairjourney Biologics

FairJourney Biologics ("FJB") is a leading biologics CRO, providing integrated services across antibody discovery, engineering, and production to global biopharma. Founded in 2012 and headquartered in Porto, FJB has grown to over 120 highly technically skilled employees today. The company operates a flexible, customer-oriented 'one-stop shop' approach to biologics development focused on quality, reliability, and partnership. The company's significant expertise in phage display technology, combined with a diverse approach to generating both immune and naïve antibody libraries have contributed to a market leading 99%+ project success rate.

For more information visit www.fjb.pt

IONTAS was recently integrated in the FairJourney Group and offers services for antibody discovery using phage display technology and mammalian display. The innovative mammalian display platform enables full-length antibodies to be expressed in the context of a mammalian cell, thereby allowing selection based on function, stability, expression and developability.

For more information visit www.iontas.co.uk