Cizzle Biotechnology Holdings PLC on Monday announced that its proprietary test for the CIZ1B biomarker has been chosen as part of ‘an important clinical study’ at a ‘leading’ US cancer centre.
Shares in Cizzle were up 4.1% to 1.51 pence each on Monday afternoon in London.
The London diagnostics developer company, which is developing a blood test for the early detection of different forms of lung cancer, said the selection was thanks to early collaboration with Cizzle Bio Inc, its planned strategic and exclusive licensing partner in the US.
At the ‘major cancer centre’, Cizzle will evaluate CIZ1B testing to confirm whether lung nodules identified by CT scanning are positive for the CIZ1B biomarker.
Cizzle announced the signing of a memorandum of understanding with Bio in early April, after which it received an initial non-refundable $100,000 payment, granting Bio a 120-day exclusive negotiating period. It expects a further $300,000 once a binding legal agreement is completed, granting Bio an ‘exclusive licence to develop and market clinical diagnostic assays based on the CIZ1B biomarker to facilitate the early detection of lung cancer in North America’.
Subsequently, ‘guaranteed’ minimum advance royalty payments of $2.3 million will be due over a 30 month period, as part of the 10% royalty payable on gross revenue. Cizzle will also own 10% of Bio.
Cizzle said it ‘has been working closely with Bio’s US management team to determine a timetable with key milestones for bringing the company’s CIZ1B biomarker test to market’.
Cizzle said Bio expects to register its first US clinical laboratory improvement amendments-accredited lab with the Food & Drug Administration in September, with full product launch planned for April 2025.
‘After years of research at the University of York and further investment and development by Cizzle, the company is now at an exciting inflection point,’ commented Executive Chair Allan Syms.
‘The partnership...has opened doors to work with major cancer centres, brings clarity to route and time of first product launch and generates guaranteed revenue streams going forward.
‘This is an exciting time for Cizzle Biotechnology and I look forward to completing the binding agreement with Bio and providing more details on the significant clinical trial programme with top hospitals in the territory, in due course.’
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