NEW YORK – UK-based diagnostics developer Cizzle Biotechnology said Monday that it has signed an exclusive licensing agreement with its US-incorporated partner Cizzle Bio for the rights to commercialize in the US and Canada a proprietary biomarker-based immunoassay for the early detection of lung cancer.
Cizzle Biotechnology said that its CIZ1B blood test for the detection of lung cancer is being evaluated in a clinical study at the Moffitt Cancer Center, and the firm hopes to receive CLIA accreditation for the test this year followed by a product launch in North America in April 2025. The study results will be used to help validate the use of the test to differentiate between malignant and benign lung nodules.
"The structure of the agreement not only secures immediate and long-term revenue for Cizzle but also positions us to expand into new markets and drive further innovation, such as our point-of-care test," Cizzle Biotechnology Executive Chairman Allan Syms said in a statement. "By collaborating with a highly experienced and well-funded US-based team, we are accelerating the delivery of our CIZ1B biomarker test to market, bringing hope to millions of patients through early lung cancer detection."
Cizzle Biotechnology said that Cizzle Bio, which is an independently funded corporation, has agreed to cover the costs of clinical evaluations, accreditation, and marketing of CIZ1B immunoassays in North America. Under the terms of the deal, the UK-based firm will receive royalties of 10 percent of gross sales after tax and a minimum of $2 million in royalty payments over 30 months, and the US-based company has already made an upfront royalty payment of $300,000. Cizzle Biotechnology also will benefit from the increased value of Cizzle Bio through an equity agreement.
The deal also involves incentives for Cizzle Bio through milestone-based payments to accelerate the marketing of a CIZ1B immunoassay in North America. Cizzle Bio expects to soon announce its first contract with a clinical laboratory.
Cizzle Biotechnology had announced in April a memorandum of understanding in anticipation of the licensing deal, and Cizzle Bio agreed to pay an upfront fee of $100,000 for a 120-day exclusivity period. That payment was in addition to the $300,000 royalty payment.
It said at the time that Cizzle Bio would collaborate with San Antonio, Texas-based CorePath Laboratories, and the firms planned to restructure a royalty agreement that was inked by Cizzle Biotechnology and CorePath when the firms forged a partnership in 2022 on plans to develop and offer a liquid biopsy test for early-stage lung cancer.
Cizzle Biotechnology is a spinout of the University of York, where researchers who were studying the cell nuclear protein CIZ1, which is involved in DNA replication, determined that the variant CIZ1B is connected with early-stage cancer. The firm said that it plans to expand testing to new regions as well as advance the development of a point-of-care lung cancer test.