REG - Cizzle Biotechnology - Expansion of Research Agreement and CIZ1B Update

Cizzle Biotechnology HoldingsAnnouncement

10/08/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230810:nRSJ8524Ia&default-theme=true

RNS Number : 8524I  Cizzle Biotechnology Holdings PLC  10 August 2023

10 August 2023

Cizzle Biotechnology Holdings Plc

("Cizzle Biotechnology" or the "Company")

Expansion of Research Agreement with the University of York for Cancer Diagnosis and Therapy and Update on Progress to Launch CIZ1B Biomarker Early Stage Lung Cancer Test

 

Cizzle Biotechnology, the UK based diagnostics developer, is pleased to
announce an expansion of its current research programme with the University of
York to develop its CIZ1B biomarker technology for early stage cancer
diagnosis, and other potential applications in cancer therapy. This follows
significant progress in isolating additional new and specific monoclonal
antibodies to the CIZ1B biomarker and incorporating these into a new
high-throughput clinical diagnostic immunoassay platform. The recent
developments meet key milestones to begin commercial clinical trials. The
Company is now engaged in clinical trials design to support the validation and
accreditation of the CIZ1B test prior to commercial launch.

 

Highlights

 ·    Successful development of additional specific monoclonal antibodies
 for CIZ1B Biomarker

 ·    Application to a new high-throughput immunoassay platform.

 ·    Significant expansion of current research and development agreement
 with the University of York, to allow continued access to state of the art
 facilities and world-leading scientists.
 ·    All intellectual property rights arising from the work to be owned by
 the Company

 

Cizzle Biotechnology and the University of York have benefited from a
long-standing close relationship since the Company was spun out from the
University in 2006. That collaboration has continued since the Company was
admitted to trading on the London Stock Exchange and currently has a funded
programme until 25 September 2024. During this period the team at the
University of York under the direction of Professor Dawn Coverley has
successfully isolated and validated an additional panel of specific monoclonal
antibodies for the CIZ1B biomarker, which is highly associated with early
stage lung cancer.

 

A key milestone for the Company was to take the proof of concept test for
CIZ1B and develop an accredited and commercially viable assay that could be
used in a laboratory to test for early stage lung cancer. A common first
approach to achieve this, known as an enzyme-linked immunosorbent assay
(ELISA), involves a multistep process of analysing multiple blood samples in
either manual or robotic handling systems. A major breakthrough by the team at
the University of York has significantly improved on this traditional approach
using alternative high-throughput assay formats for CIZ1B, that will now be
used as the basis for a commercial product.

 

The next steps are to finalise standard production and operating protocols and
to commence clinical trials that should lead to an accredited Laboratory
Developed (LDT) test for launch initially in the USA. The Company will then
extend that to other key markets and will extend its use through regulatory
approval with the FDA in the USA, the EMA for a CE mark in Europe, the MHRA in
the UK for UKCA approval, and with the appropriate regulatory groups elsewhere
in the world including China.

 

Cizzle Biotechnology will continue to own all intellectual property rights
and, through its further funding of research programmes at the University of
York, aims to create new solutions for early cancer diagnostics and develop
new therapeutic tools.

 

Commenting, Allan Syms, Executive Chairman of Cizzle Biotechnology, said: "The
University of York has been the home of the Company's research and development
from its inception. Under the expert and insightful leadership of Professor
Coverley, the laboratory team have made excellent progress in developing our
test for the CIZ1B Biomarker to be used for detecting lung cancer at its
earliest stage. This provides a much-needed solution to early diagnosis, which
can save lives. The latest exciting developments have met important milestones
and so I am delighted to expand our investment with the University, which
continues to provide support to the Company from the leading-edge research and
state of the art laboratories. This new agreement aligns will an exciting
phase of the Company's plans to achieve regulatory approval and bring our
early detection tests for lung cancer to market."

 
Enquiries:

Cizzle Biotechnology Holdings
plc                                Via IFC
Advisory

Allan Syms (Executive Chairman)

 

Allenby Capital Limited
 
+44(0) 20 33285656

John Depasquale Alex Brearley

 

Novum Securities Limited                                               +44(0) 20 7399 9400

Colin Rowbury Jon Belliss

 

IFC Advisory Limited                                                          +44(0) 20 3934 6630

Tim Metcalfe Florence Chandler

 

About the Company

Cizzle Biotechnology is developing a blood test for the early detection of
lung cancer. The Company is a spin- out from the University of York, founded
in 2006 around the work of Professor Coverley and colleagues. Its
proof-of-concept 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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCEAKPNEAEDEFA