Cizzle Bio, Inc. Announces Strategic Partnership with BBI Solutions for Monoclonal Antibody Manufacturing
Introduction
Cizzle Biotechnology Holdings plc is thrilled to announce a strategic agreement with BBI Solutions to supply its first order of commercial proprietary monoclonal antibodies. This partnership marks a significant milestone in Cizzle's mission to commercialize its cost-effective biomarker test for early-stage lung cancer detection.
Key Highlights:
Partnership with BBI Solutions: BBI will manufacture commercial CIZ1B monoclonal antibodies.
Certified Manufacturing: Production in ISO 13485-certified facilities ensures adherence to stringent quality standards.
Sufficient Initial Supply: The first batch will support up to 5000 blood tests for the CIZ1B biomarker.
Supporting Clinical Evaluation: The antibodies will facilitate clinical evaluations with a major US cancer center, crucial for confirming the presence of lung cancer in patients with indeterminate lung nodules identified by CT scans.
Commercialization and Regulatory Strategy:
US CLIA Accreditation: Cizzle Bio aims to register its first US CLIA accredited lab with the FDA for the CIZ1B LDT test in September 2024.
CLIA Certification and Product Launch: Cizzle Bio plans to achieve CLIA certification for the LDT in November 2024, with an anticipated product launch and insurer reimbursement code achievement by April 2025.
Point of Care Development: Plans include developing a POC test for use in pharmacies, doctors’ offices, and by healthcare providers.
Expanded Research: Continued R&D at the University of York to explore the utility of CIZ1B in detecting other cancers.
Further Information:
With nearly 5000 lives lost daily to lung cancer, largely due to the lack of a simple early detection test, Cizzle is dedicated to bringing its proprietary CIZ1B test to market as quickly as possible. This partnership with BBI is a pivotal step in providing reliable clinical results and developing a user-friendly point-of-care test.
The supply of the new commercial monoclonal antibodies will be used to provide clinical results on patients suspected to have early-stage lung cancer arising from CT scanning in the US cancer center, developing a simple finger prick point-of-care test for the CIZ1B biomarker, and continuing Cizzle’s work to determine the utility of the test for other cancers.
Quotes:
Allan Syms, Executive Chairman of Cizzle Biotechnology: "We are making significant progress in bringing the company’s CIZ1B test to market. CIZ1B is highly associated with early-stage lung cancer, and we are now at a point where the test will be made available to clinicians and patients to help in the drive to detect cancer early and as a result save lives."
Mario Gualano, CEO of BBI: "We are excited to partner with Cizzle Biotechnology in their mission to bring an innovative lung cancer detection test to market. Our expertise in producing high-quality immunodiagnostic reagents will ensure that Cizzle's CIZ1B monoclonal antibodies meet the highest standards."
About Cizzle Biotechnology:
Cizzle Biotechnology is a UK-based diagnostics company focused on developing a cost-effective biomarker test to help detect early-stage lung cancer. Spun out from the University of York in 2006, the company was admitted to the Standard segment of the main market of the London Stock Exchange in May 2021. Its test is based on the detection of a stable plasma biomarker, a variant of CIZ1 known as CIZ1B, which is highly correlated with early-stage lung cancer.
About Cizzle Bio, Inc.:
Cizzle Bio Inc, a company registered in Texas, USA, is dedicated to improving cancer patient survival through the early detection of lung cancer using the CIZ1B biomarker test. The company is led by Bill Behnke, an accomplished entrepreneur with extensive experience in healthcare business development.
About BBI Solutions:
BBI Solutions is a leading global immunodiagnostic reagents producer, specializing in high-quality raw materials and custom development solutions. The company’s ISO 13485 certification underscores its adherence to the highest global standards, ensuring superior performance and compliance.
Conclusion:
This strategic partnership with BBI Solutions represents a significant advancement in Cizzle Bio's mission to bring its innovative lung cancer detection test to market, potentially saving thousands of lives through early diagnosis.
For more information, please visit BBI Solutions.
