REG - Cizzle Biotechnology - Collaboration with Moffitt Cancer Center

Cizzle Biotechnology HoldingsAnnouncement

09/09/2024 07:00

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RNS Number : 3273D  Cizzle Biotechnology Holdings PLC  09 September 2024

9 September 2024

Cizzle Biotechnology Holdings plc

("Cizzle", "Cizzle Biotechnology", or "the Company")

Collaboration with Moffitt Cancer Center to evaluate patients with suspected
lung cancer

 

Cizzle Biotechnology, the UK based diagnostics company focused on developing a
cost-effective biomarker test to help detect early-stage lung cancer, is
pleased to announce that it has been selected by the Moffitt Cancer Center
("Moffitt"), the number one cancer hospital in Florida and the Southeast USA,
to test patients with suspicious lung nodules in a clinical evaluation using
the Company's proprietary CIZ1B biomarker assay.

With multiple sites and over 7000 employees, Moffitt is the only US National
Cancer Institute-designated 'Comprehensive Cancer Center' based in Florida.
They have developed a comprehensive lung cancer screening programme that is
among the best in the United States, which has resulted in them being named a
Screening Center of Excellence by the GO2 Foundation for Lung Cancer.
(https://go2foundation.org/for-professionals/excellence-in-screening-and-care/)

Highlights

·   Collaboration with Moffitt Cancer Center, a leading dedicated cancer
centre in the USA

·   First time suspected lung cancer patients will be tested for the CIZ1B
Biomarker as part of a major clinical evaluation

·   Study follows US national guidelines

·   Cizzle selected after scientific review by Moffitt and as a result of
the Company's partnership in the USA with Cizzle Bio Inc

·   First use of new monoclonal antibodies to be delivered shortly by
Cizzle's strategic commercial manufacturing partner, BBI Solutions

·   Blood samples from US patients will be analysed at the University of
York

·   More clinical collaborations planned by Cizzle BIO in the USA

·   Will help validate use of CIZ1B for early lung cancer detection

As part of Moffitt's Phase 2 programme, "Using Biomarkers for Diagnosis, Risk
Stratification of Post-treatment Recurrence and Long Term Survival of Lung
Cancer", a large observational prospective study in patients with suspicious
indeterminant (undiagnosed) lung nodules seen in the Lung Cancer Early
Detection (LEAD) Center Lung Nodule Clinic, led by its Director Dr. Lary
Robinson, the Company will for the first time be analyzing patient blood
samples to determine biomarker accuracy in predicting whether or not a nodule
is likely to be cancer. The study follows US nationally recommended guidelines
and will be using the first batch of the Company's new commercial monoclonal
antibody, to provide new sensitivity and specificity data of the CIZ1B
biomarker blood test in the diagnosis of early-stage lung cancer in people
with indeterminant lung nodules. The blood sample tests for CIZ1B will be
conducted in Professor Dawn Coverley's laboratory at the University of York.

The collaboration with Moffitt arises from the progress being made, and
extensive network being generated, by the Company's US licensing partner
Cizzle Bio Inc ("BIO"). The Company expects to shortly complete its formal
licensing agreement with BIO following the signing of a MOU with them on 2
April 2024, which was extended until 30 September 2024. Since signing the MOU,
BIO have been establishing clinical partnerships across the USA as part of a
planned expansion to make the CIZ1B biomarker test available throughout North
America. BIO expect to announce further clinical evaluations with additional
major cancer centers and clinics this year, to be conducted in their growing
network of laboratories accredited by the College of American Pathology
Pathologists (CAP) with Clinical Laboratory Improvement Amendments (CLIA)
certification. On signing of the full agreement with BIO a further US$300,000
advance royalty fee will be paid to the Company.

Further Information

More people die from lung cancer than any other cancer, and every day nearly
5000 people lose the battle to survive. This is due, in large part, to the
unmet clinical need for a simple blood test that can detect lung cancer at an
early-stage. While both the USA and UK are rolling out screening programmes
based on low dose CT scanning, uptake has been poor and still too many people
present with suspicious lung nodules that are not cancer, leading to
unnecessary stress, avoidable radiation, high costs and consumption of
valuable clinician time. The identification of the CIZ1B biomarker and its
association with early-stage lung cancer offers an opportunity to add a
valuable tool in the clinician's armoury to improved cancer detection rates
and ultimately save lives. The Company remains focused on bringing its
proprietary test forCIZ1B to market at the earliest opportunity. Bringing the
test initially to the USA provides an important platform to then enter new
markets and meet the demand for a cost-effective biomarker test globally.

Allan Syms, Executive Chairman of Cizzle Biotechnology, said:

"Today's announcement of the collaboration with the Moffitt Cancer Center
marks a major inflection point in the Company's development, and delivery of
our proprietary CIZ1B biomarker test to market, by enabling patients in a
major cancer clinic with suspicious lung nodules to be tested for the presence
of the biomarker.  Having transitioned from the development phase into full
commercial manufacture of the Company's CIZ1B monoclonal antibody and in
establishing a guaranteed royalty bearing licence with our US partners Cizzle
BIO, we are now able to forge new links with doctors, hospitals and major
cancer clinics, initially in North America and then to make the test available
elsewhere in the world.

"The collaboration with Moffitt is significant given their leading position as
one of the largest dedicated cancer centers in the USA and already
demonstrates the benefit of our new relationship with our US partners Cizzle
BIO. This will be the first-time patients with suspicious lung nodules, will,
as part of their clinical assessment provide blood samples in a prospective
study to test for the CIZ1B biomarker. The results could benefit patients by
helping reduce false positives associated with CT screening and provide a
valuable tool in helping clinicians identify at risk patients that may have
early-stage lung cancer."

Dr. Lary Robinson, Director of the Lung Cancer Early Detection (LEAD) Center
Lung Nodule Clinic at Moffitt Cancer Center, said:

"The only current, proven way to find lung cancer early is with low-dose
screening chest CT scans for individuals considered high risk. But,
unfortunately, we have only been able to get 6% of people at risk to obtain
this scan.  However, even with chest CT scans, at least 25% of patients will
be found to have a lung nodule. The majority of these are false positive
results, that nevertheless require careful evaluation, often invasive tests,
and long-term follow-up.

"Development of a reliable, highly accurate blood biomarker for discovery of
early-stage lung cancer would be a tremendous advancement and would be far
easier to implement in the routine clinical setting. There are three scenarios
where a highly accurate blood test would be of potential benefit: 1. Aid in
the determination of whether an indeterminant lung nodule found on CT scan is
cancer; 2. Use as a primary blood screening test for lung cancer; 3. Use for
periodic long-term surveillance for recurrent lung cancer or second primary
lung cancer for patients who have had curative lung cancer treatment.  I am
hopeful that the CIZ1B biomarker will prove to be that much-desired lung
cancer diagnostic test."

Bill Behnke, Chairman and CEO of Cizzle Bio Inc, commented:

"The team at Cizzle Bio is grateful for the positive reception we have
received in the short 7 months we have been in the market. Early detection is
crucial in saving lives and we find it quite inspiring to watch the healthcare
community welcome us with strong interest in the CIZ1B test that will have a
positive impact on so many lives."

Enquiries:

 

 Cizzle Biotechnology Holdings plc                            Via IFC Advisory

 Allan Syms (Executive Chairman)

 Allenby Capital Limited                                      +44(0) 20 3328 5656

 John Depasquale/George Payne (Corporate Finance)

 Stefano Aquilino/Amrit Nahal (Sales and Corporate Broking)

 Novum Securities Limited                                     +44(0) 20 7399 9400

 Colin Rowbury / Jon Bellis

 IFC Advisory Limited                                         +44(0) 20 3934 6630

 Tim Metcalfe / Florence Chandler

About Cizzle Biotechnology

Cizzle is developing a blood test to help in the early detection of lung
cancer. The Company was spun out from the University of York, in 2006, around
the work of Professor Coverley and colleagues and was admitted to the Standard
segment of the main market of the London Stock Exchange in May 2021. Its test
is based on the ability to detect a stable plasma biomarker, a variant of CIZ1
known as CIZ1B. Normal CIZ1 is a naturally occurring cell nuclear protein
involved in DNA replication, and the targeted CIZ1B variant has been shown to
be highly correlated with early-stage lung cancer. For more information,
please see https://cizzlebiotechnology.com (https://cizzlebiotechnology.com/)

You can also follow the Company through its twitter account @CizzlePlc and on
LinkedIn.

About Moffitt Cancer Center

Moffitt (https://moffitt.org/) is dedicated to one lifesaving mission: to
contribute to the prevention and cure of cancer. The Tampa-based facility is
one of only 57 National Cancer Institute-designated Comprehensive Cancer
Centers (https://www.cancer.gov/research/nci-role/cancer-centers) , a
distinction that recognizes Moffitt's scientific excellence, multidisciplinary
research, and robust training and education. Moffitt's expert nursing staff is
recognized by the American Nurses Credentialing Center with Magnet(®) status,
its highest distinction. For more information, visit MOFFITT.org
(http://www.moffitt.org/) , and follow the momentum on Facebook
(https://www.facebook.com/MoffittCancerCenter) , Twitter
(https://twitter.com/moffittnews) , Instagram
(https://www.instagram.com/moffittcancercenter/) and YouTube
(https://www.youtube.com/user/MoffittNews) .

About Cizzle Bio

Cizzle Bio, Inc. stands at the forefront of biotechnological innovation,
dedicated to revolutionizing the detection of lung cancer through
groundbreaking diagnostic tools. We are driven by a commitment to improve
early cancer detection and enhance patient outcomes. With a passion to improve
cancer patient survival and recognising that one of the main causes of poor
survival rates for certain cancers, and in particular lung cancer, is because
diagnosis is often when the disease is at an advanced state, there is an unmet
need for a simple blood test that can be used to detect cancer early.  As a
result of the strategic importance of the USA, Cizzle and BIO have entered
into a MOU which will shortly become an exclusive licensing agreement for the
CIZ1B biomarker in the USA and Canada. BIO has already made significant
progress in adding a Chief Medical Officer to its experienced healthcare
management team and in forging links with large physician groups, hospitals
and major cancer centers across the USA.

You can find more about Cizzle BIO at Early Lung Cancer Detection | Innovative
CIZ1B Biomarker Blood Test | Cizzle Bio, Inc. (https://www.cizzlebio.com/)

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