SuperFolder CD19 for detection of CAR-T cells

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The CAR-T cell therapy is a personalized and highly potent anti-cancer treatment that uses the patient’s own immune system to attack cancer cells. However, CAR-T cells are difficult to monitor in a patient, complicating an assessment of their expansion and function in vivo. We have developed an easy solution to study leukemia- and lymphomaspecific CAR-T cells in patient samples, as well as in laboratory experiments. Approved CAR-T cell therapies target the B cell surface marker CD19. Since CAR-T cells act as a “living drug” within the patient, it is imperative to monitor their expansion, persistence and function. For optimal monitoring and diagnostics, the specifically recognized CAR antigen (i.e., CD19) represents the perfect staining reagent for CAR-T cells. However, CD19 is classified as a “difficult-to-express” protein that is prone to aggregation and misfolding, representing a major obstacle for the development and analysis of CD19-targeted therapeutics. Technology: We engineered stabilized CD19 variants, called SuperFolder CD19, which are wellfolded and easy to produce in large quantities. Importantly, in contrast to the misfolded and aggregated wild type protein, our final SuperFolder CD19 candidate enables the monitoring and phenotypic characterization of CAR-T cells in the blood of cancer patients using flow cytometry. Thus, the SuperFolder CD19 is a valuable tool in clinical settings to immediately assess a patient’s treatment using standard flow cytometry instruments and to make early and better informed decisions for that patient’s continued care.

Use CasesContent extracted from patent full text and abstract with AI.

• Clinical monitoring & diagnostics for CD19 CAR-T therapy
• Research & development tool for CAR-T characterization

BenefitsContent extracted from patent full text and abstract with AI.

• SuperFolder CD19 is fully functional & highly stable
• Monitoring of CAR-T cells in patient samples
• Analysis of CAR-T cell subtypes and their activation/exhaustion
• Assessment tool for CAR-T cell efficacy

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Patent Abstract

An extracellular domain of CD19 (CD19-ECD) which comprises at least 90% sequence identity to SEQ ID NO:1, a first core region at positions 2-98 of SEQ ID NO:1, a second core region at positions 167-258 of SEQ ID NO:1, a third core region at positions 99-166 of SEQ ID NO:1, and at least one stabilizing point mutation at an amino acid position within said first and/or second and/or third core regions, wherein the CD19-ECD has an increased thermal stability compared to CD19-ECD which consists of an amino acid sequence identified as SEQ ID NO:1.