Cizzle Biotechnology Holdings PLC Expansion of Research Agreement and CIZ1B Update (8524I)
10 Agosto 2023 - 1:00AM
UK Regulatory
TIDMCIZ
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.
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