Cizzle Biotech Regulatory News (CIZ)

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.

3 February 2022

Cizzle Biotechnology Holdings Plc

("Cizzle Biotechnology" or the "Company")

Royalty Strategic Alliance for Early Lung Cancer Detection in China

Cizzle Biotechnology, the UK based diagnostics developer, is pleased to announce that following the signing of a Memorandum of Understanding ("MOU") with the International Co-Innovation Centre for Advanced Medical Technology ("iCCAMT") and Shenzhen Intelliphecy Life Technologies Co., Ltd. ("Intelliphecy"), announced on 25 November 2021, a full commercial agreement has now been executed to develop and market the Company's proprietary early lung cancer diagnostic tests in China (the "Agreement").

Highlights

· Commercial agreement reached with iCCAMT and Intelliphecy

· iCCAMT backers include German Medical Valley, Robert Bosch GmbH and Sinopharm Group

· iCCAMT and Intelliphecy to fund all activities in China, including development, clinical trials, manufacture and distribution

· 10% royalty for the Company over all sales of products and services using CIZ1B in China

· Initial pilot of 300 patients planned

Background

Around 816,000 new lung cancer cases were diagnosed in China in 2020, accounting for almost 18 percent of all the 4.6 million new cancer cases in China. In that year, approximately three million deaths in China were caused by cancer*. It is also known that there are serious challenges in being able to detect cancer early and a great need for screening and diagnosing cancers among the Chinese population when targeted interventions can improve timely access to cancer care and save lives**.

The Agreement

The Agreement will generate future revenues for Cizzle Biotechnology via a 10% royalty on the sales of all products and services using its proprietary CIZ1B technology and from payment for monoclonal antibodies and reagents.

The China partners will be solely responsible for funding all activities in China including development, clinical trials, manufacturing, and distribution. It is intended that initial development will commence within 60 days of Cizzle Biotechnology supplying its immunoreagents to the China partners, which is anticipated to be in Q2 2022.

An initial pilot covering 300 patients is planned at China's premier cancer hospitals, which will allow for a true representative patient cohort to be included and, if successful, is expected to accelerate adoption and product rollout in China.

The China partners

iCCAMT, founded with German Medical Valley, Robert Bosch GmbH and Sinopharm Group, aims to accelerate global med-tech innovation in the Chinese market, by bringing together world leading expertise. The strategic alliance is intended to accelerate product development and clinical trials to achieve early adoption within major cancer centers throughout China.

Intelliphecy is aiming to innovate technologies in the hope to win the war against cancer, aspiring to out-smart cancer cells with an intelligent prophecy. At the core of Intelliphecy's technology portfolio lies artificial intelligence driven big data analytics, which is devoted to predictive modeling of cancer, a methodology which has proved timely given the global pandemic's digital health and data adoption trends.

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

"As reported in November 2021, when we signed our MOU with iCCAMT and Intelliphecy, lung cancer in China is a huge social and economic challenge, especially because of the difficulties in being able to detect it early enough to make clinical intervention effective. We are now pleased to report that as planned we have completed detailed commercial negotiations and have entered into a full binding agreement that will enable us to bring our early cancer testing technology to this important market. Our Chinese partners will be financing all activities in China in exchange for providing us with important and repeatable royalty revenues and covering the costs for all key reagents and our proprietary monoclonal antibodies. We are excited to be working with our new partners in China and look forward to beginning our initial pilot trials with China's leading scientists and centers of excellence."

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

"This agreement represents a significant opportunity to bring early and cost-effective cancer detection to the people of China. It is estimated that about 95.8 million people in China have a high risk of lung cancer and if screening was performed every three years, then more than 30 million tests per year would be required. At a target price of about £100 per test, the total available market for tests based on the CIZ1B biomarker would be £3 billion. (Frost & Sullivan estimates the market size in China is US$5.7 billion). We have already secured strong interest from our nationwide network of national clinical centers and key opinion leaders because of the promising results using the CIZ1B biomarker for lung cancer early detection in the UK and one our first tasks is to commence pilot studies at the Cancer Hospital, Chinese Academy of Medical Sciences, National Cancer Centre, and Beijing Cancer Hospital, affiliated with Peking University."

Commenting, Dr Xiaoyun Huang, CEO and Founder of Intelliphecy said:

"Lung cancer is the one with the highest incidence in China. The fact that many lung cancer patients are diagnosed with advanced disease hampers therapeutic efficiency and patient survival. There is an urgent need for early lung cancer detection in China. We are extremely happy to have finalized the details of a formal agreement on a Royalty Strategic Alliance for Early Lung Cancer Detection in China with Cizzle and iCCAMT. This marks the first milestone of our strategic alliance since the signing of MOU. We are looking forward to initiating the development of CIZ1B based early lung cancer detection products and services as soon as possible."

Enquiries:

Notes to Editors:

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, 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 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 Shenzhen Intelliphecy Life Technologies Co., Ltd. ("Intelliphecy")

Intelliphecy is aiming to innovate technologies in the hope to win the war against cancer, aspiring to out-smart cancer cells with an intelligent prophecy. At the core of Intelliphecy's technology portfolio lies artificial intelligence driven big data analytics, which is devoted to predictive modeling of cancer hallmarks using quantitative information. Its research and development is grounded in both identification of cancer at early stage and prediction of optimal treatment strategies for individual cancer patients. Intelliphecy has established research collaborations with major cancer centres throughout China.

For more information, please see http://www.intelliphecy.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 southeastern 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 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.

About Beijing Cancer Hospital affiliated with Peking University

Peking University Cancer Hospital & Institute is one of the top academic cancer centers in China. It is devoted to offering the best of evidence-based and patient-centered medical care, conducting high-level basic and translational researches, and providing high-quality basic medical teaching and specialisation training programs. Peking University Cancer Hospital & Institute is one of the most versatile cancer centers in China, using surgery, radiation therapy, chemotherapy and interventional therapy to treat a wide range of tumors, especially gastrointestinal cancers, breast cancer, melanoma, lymphoma, liver cancer and lung cancer. It advocates multidisciplinary cooperation, integrating all available expertise and resources to offer patients the best tailored comprehensive therapies possible. Peking University Cancer Hospital & Institute has a strong capacity in basic and clinical studies on cancer. There are more than 140 talented researchers working in 10 laboratories equipped with the most advanced apparatus and up-to-date research technologies in cell biology, proteomics and genomics. Prominent progress has been achieved in research on carcinogenesis, cancer prevention, biology, epidemiology and biotherapy relating to the most common cancers in China, especially gastric cancer and breast cancer.

References

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

** https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(21)00157-2/fulltext