Personalized CAR-T Immunotherapy Platform

Transcription

1 GLP, GMP, and CLIA-Certified Lab Personalized CAR-T Immunotherapy Platform Accelerate your cancer research and drug discovery

2 Platform Overview 1500 Existing Hybridomas and Antibody Engineering Custom Lentiviral CAR Construction (GMP) High-Throughput Multiplex Cytotoxicity Assays In Vivo Efficacy and Toxicity Validation CAR-T Cell Manufacturing (GMP) NRAS EGFR VIII CD19 Biomarker Discovery QClamp Genomic Profiling Fluorescence Cycle Melting Profile Next-Generation Sequencing CAR-T Infusion Treatment Powered by DiaCarta Genomics and ProMab CAR-T Technologies

3 Comprehensive Services by the Personalized CAR-T Immunotherapy Platform Genomic Profiling Biomarker discovery and CAR-T profiling Gene mutation analysis by QClamp XNA-PCR Gene expression by QuantiMarker TM assays OptiSeq TM next-generation sequencing GLP and CLIA lab settings Cytokines Assays Bead-based multiplex protein tests run on Bio-Rad Bio-Plex platform Standard assays for cytokine detection in activated CAR-T cells (e.g. IL-2, IL-6, IFN-ϒ) Customized assays for quantitating up to 50 cytokines GLP and CLIA lab settings CAR-T Services Focus on generating CAR for murine-based pre-clinical studies or use as a clinical tool Antibody discovery (hybridomas, mouse, rabbit and human library) Customized lentiviral CAR construction CAR-T cell manufacturing Real-time cytotoxicity assay (RTCA) Multiplex cytokine screening Mouse in vivo efficacy and toxicology modeling In vivo imaging by Xenogen/PerkinElmer IVIS system GMP manufacturing of CD3/CD28 beads (coming soon) GMP manufacturing of lentiviral CAR (coming soon)

4 In the era of the Cancer MoonShot 2020 Program - the nation s most comprehensive cancer collaborative initiative to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients, DiaCarta and ProMab have joined hands to offer the next-generation Chimeric Antigen Receptor T-Cell (CAR-T) immunotherapy platform. OptiSeqTM detects what other NGS platform missed Real-Time Cytotoxicity Assay (RTCA) shows CD19 CAR NK cell s cytotoxic activity and IFN-gamma secretion by CD19 CAR T-cells QClamp detects mutant DNA template with ultra sensitivity (< 0.1%) 5 50% MT Fluorescence 4 10% MT 5% MT 1.5 1% MT % MT Cycle Control QClamp JAK2 V617F mutant dilution study shows < 0.1% detection sensitivity of mutant DNA About Our Platform QClamp XNA-PCR platform dramatically suppresses wild-type DNA template to provide ultra sensitive detection for mutant template. OptiSeqTM next-gen sequencing enriches mutant targets to enable 10x lower limit of detection than conventional methods. These platforms are ideal for the screening of human antibody libraries and detection of rare mutations in oncogenes such as NRAS and EGFR VIII as well as CD19-specifc chimeric antigen receptor. CytoPlexTM cytokine assays are solutions for assessing multiple protein biomarkers in a single tube, powered by a unique multiplex bar-coding technology. Using SuperbDNATM signal amplification technology, QuantiMarkerTM can effectively detect overexpression of tumor antigens and develop neo-tumor antigen discovery. CAR-T service is a completely inclusive program based on antibody products from the generation of a single-chain variable fragment (scfv) targeting your tumor antigen to in vitro cytotoxicity analyses and in vivo animal modelling. The sophisticated computer modeling and bioinformatics approaches are applied to the antibody humanization projects. This repository and fully human antibodies provide a source of multi-affinity clones to tackle novel therapies and questions of cytotoxic specificity.

5 Features and Benefits at a Glance QClamp (qpcr) Ultra sensitive: detect 0.1% mutations Rapid: turn around time ~ 2 hours Sample ready: suitable for liquid biopsy, FFPE sample and more Versatile: works with most PCR machines Reproducible: robust XNA-PCR minimizes variability ACGA GATACA CATCA TCA OptiSeq TM (NGS) Ultra sensitive: detect 0.1% mutations and < 1% indels Rapid: 10x lower sequencing depth in 3 to 5 days Accurate: fewer errors by enriching mutant reads Sample ready: suitable for ctdna, CTC and FFPE samples Reproducible: robust XNA-PCR minimizes variability Affordable: reduce number of reads by 10x Cytoplex TM (Multiplex Protein Tests) Mutiplex: measure 50 analytes simultaneously Rapid: turn around time 3 hours (analysis of up to 50 cytokines in 80 samples) Cost efficient: use only 25 to 50 µl of sample with lower amount of reagents Sensitive: bead-based assay with ultra signal amplification Streamlined: custom data interpretation and reporting QuantiMarker TM (Gene Expression Assays) Convenient: direct assay on samples without RNA purification Sensitive: signal amplification by SuperbDNA TM technology Accurate: quantitate original RNA population directly from lysates Sample ready: compatible with all tissues and fluid types Simple to use: standard ELISAlike assays with luminometer CLIA- Certified Lab Clinical operations in both United States and China with same LIMS and quality system GMP-compliance lab over 18,000 square feet Oncology and pathology expertise High regulatory and compliance standards Flexibility to handle evolving needs Strong customer support CAR-T Services Expertise in humanizing mouse -specific single chain variable fragment (scfv) to generate CAR-T cells with fully human extracellular recognition domain Capable of combined testing of CAR-T cells and checkpoint inhibitors plus modulators Productive and experienced in antibody development with 1500 commercial monoclonal antibodies Dedicated CAR-T scientists and project managers Total solution for precision medicine

6 Innovative Personalized CAR-T Immunotherapy Platform addresses unmet medical needs and drives development of precision medicines in cancer treatment. DiaCarta, Inc ProMab, Inc Discover more at and