Cizzle Biotech Regulatory News (CIZ)

23 November 2022

Cizzle Biotechnology Holdings Plc

("Cizzle Biotechnology" or the "Company")

Clinical Pilot Study for Early Lung Cancer Detection in China

Cizzle Biotechnology, the UK based diagnostics developer, is pleased to announce that today, at an official signing ceremony at the Chinese Medical Equipment Fair ("CMEF"), it signed a further Memorandum of Understanding ("MOU") with the International Co-Innovation Centre for Advanced Medical Technology ("iCCAMT") for a clinical pilot study with the Cancer Hospital Chinese Academy of Medical Sciences, National Cancer Center of China.  This follows Cizzle Biotechnology's full commercial agreement with iCCAMT announced on 3 February 2022.

Background

Lung cancer remains the most prevalent of all cancers in China and resulted in approximately three million deaths in 2020*. This creates both a major health and economic burden with the estimated total national medical cost of treating lung cancer patients in China estimated to be over US$10 billion **.

Early diagnosis of lung cancer is important in the strategy to detect and treat the cancer early and the CMEF exhibition is China's largest healthcare event to highlight the importance of Cizzle Biotechnology's early cancer biomarker test.

The MOU

The new MOU reflects progress by iCCAMT to implement a clinical pilot study to evaluate optimised assays using a monoclonal antibody that Cizzle Biotechnology has developed that specifically detects CIZ1B, which is highly associated with stage 1 lung cancer. The initial pilot clinical studies will be conducted at the Cancer Hospital Chinese Academy of Medical Sciences, National Cancer Center of China.  These results will have the potential to provide a platform for developing full commercial tests that can be made available throughout China.

Commenting, Allan Syms, Executive Chairman of Cizzle Biotechnology, said:

"In February 2022, we signed a full commercial agreement with our partners iCCAMT and Intelliphecy to address a major social and economic challenge in China, lung cancer. Since that time, we have made significant progress in developing our reagents and monoclonal antibodies that will enable the commencement of initial pilot trials with China's leading scientists and centers of excellence.

"We are delighted to announce this further MOU focused on our clinical trial programme at CMEF which is the largest HealthTech expo in China, attracting over 100,000 attendees each year, and bringing together leading international medical equipment companies, doctors, regulators and government agencies. (https://www.cmef.com.cn/en). The event had been delayed because of COVID restrictions in China, but because of the importance of progressing partnerships in China, the signing ceremony was conducted virtually."

Commenting, Dr Hui Wu, CEO and Founder of iCCAMT said:

"This new MOU is an important document covering new progress from both sides and we are now prepared and ready to commence clinical pilot studies. The new monoclonal CIZ1B antibody developed by our British partner is now being optimized in assays to be delivered to the National Cancer Center of China in Beijing, and iCCAMT has been collaborating on the design of a pilot clinical study proposal with leading clinical researchers from the center. We are looking forward to continuing our partnership and to securing successful outcomes in the near future."

This announcement contains inside information for the purposes of article 7 of EU Regulation 596/2014 which forms part of domestic UK law pursuant to the European Union (Withdrawal) Act 2018 ("UK MAR"). Upon the publication of this announcement this inside information is now considered to be within the public domain.

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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 International Co-Innovation Centre for Advanced Medical Technology ("iCCAMT")

iCCAMT, founded with German Medical Valley, Robert Bosch GmbH, and Sinopharm Group, aims to accelerate global healthcare innovation in China. iCCAMT is dedicated to support innovative healthcare SMEs (small and medium sized companies) to grow in China and promote technology transfer. With a global health technology network and supports from industry giants, iCCAMT has developed comprehensive platforms to strengthen cross-border health technology collaborations and help global health technology companies enter the China market.

For more information, please see http://www.iccamt.com

About the Cancer Hospital, Chinese Academy of Medical Sciences, National Cancer Centre

The Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS), is located in the south-eastern part of Beijing. It was built in 1958 and is a national center of advanced cancer research and treatment, which is also rated in first place for cancer prevention and treatment in Asia in terms of scale. It is one of the World Health Organization (WHO) collaborative centers for cancer research in China and one of the bases for drug clinical trials for the Food and Drug Administration of State (SFDA). It offers advanced cancer treatment, engages in cancer research, comprehensive education and research-based prevention of both common and rare cancers. It is considered a "state-level hospital" with comprehensive oncology departments, strong technical force and advanced medical equipment. The major treatments include surgery, chemotherapy, radiotherapy, biological therapy, intervenient therapy, and laser therapy.

References

*https://www.statista.com/statistics/1042899/china-new-cancer-case-number

** Fan S, Mao Z, Lee AH, Teh-wei H (2018) Economic Costs of Lung Cancer in China. Int J Oncol Res 1:007. doi.org/10.23937/ijor-2017/1710007