Cizzle Biotechnology (CIZ) , a UK-based diagnostics developer, said its proprietary test for the CIZ1B biomarker has been selected for a major study in the US. 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.
The study will test patients suspected to have lung cancer arising from CT scanning, to be conducted at a leading cancer center in the US. Cizzle's continued assay development and clinical evaluation of CIZ1B is supported by its R&D contract with the University of York, currently set to run until July 2025.
On April 1, 2024, Cizzle signed a Memorandum of Understanding with Cizzle Bio (BIO) for an exclusive licensing agreement to develop and offer its CIZ1B test in the US and Canada. The new partnership incorporates CIZ's existing relationship with Corepath Laboratories, a full-service cancer reference laboratory, through the newly incorporated Texas-based BIO.
Today, CIZ said it has received the initial upfront payment of US$100k to grant BIO an exclusive negotiating period of 120 days from the signing of the MoU. CIZ expects a binding agreement for an exclusive license, together with an additional royalty payment of US$300k, to be completed within the 120-day window.
BIO expects to register its first US CLIA accredited lab with the FDA for the CIZ1B test in September 2024, and to achieve CLIA certification for the test in November 2024, with insurer reimbursement code and full product launch in April 2025.
Allan Syms, Executive Chairman of Cizzle Biotechnology, commenting: "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. The partnership with BIO in North America 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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Cizzle announces further positive developments regarding its partnership with BIO, and the selection of its proprietary test for the CIZ1B biomarker for a study at a leading US cancer center. CIZ shares climbed 14% on the news. CIZ1B is highly correlated with early-stage lung cancer.
Cizzle's test promises to disrupt detection of lung cancer, which remains the biggest cause of cancer deaths worldwide. The announced study represents a major endorsement of CIZ's proprietary technology. It will confirm whether lung nodules identified by CT scanning are positive for the CIZ1B biomarker, in order to develop a simple and accurate blood test for early detection.
As part of CIZ's licensing strategy for North America, it established the abovementioned partnership with newly incorporated BIO, with clear milestones to roll out the commercial test by 2025. Details of the first hospital locations, clinical trials, and initial deployment, are expected in the coming months. On completion of CIZ's agreement with BIO, Cizzle will own 10% of BIO for no cash consideration.
After years of R&D, CIZ is at a significant value inflection point with a clear commercial strategy for the US market being advanced and targeting a 2025 launch. With guaranteed royalties over a 30-month period and potential upside through CIZ's 10% ownership of BIO, Cizzle aims to address the low uptake in cancer testing in the US, relating to the US Preventive Services Task Force's target of screening 14.2 million at-risk adults.
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