Chad R. Stevens

Ligand non-competitive GITR antibody prevents formation of the obligatory signal-triggering GITRL: GITR stoichiometry

Yan Jing, Jessica Haewon Min-DeBartolo, Ching-Shin Huang, M Sharif et autres

The prevalence of autoimmune diseases such as inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) is increasing. Glucocorticoid-induced TNFR-related protein (GITR), a TNF receptor superfamily (TNFRSF) member, is activated by GITR-ligand (GITRL). GITR signaling is pathogenic in models of RA and IBD, …

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2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A – Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B – Regulatory Agencies’ Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV))

Sarah Hersey, Kristina McGuire, Olga Kholmanskikh, Nicoletta Bivi et autres

The 19th Workshop on Recent Issues in Bioanalysis (19th WRIB) took place in New Orleans, LA, USA on April 7-11, 2025. Over 1200 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest …

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2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( PART 2A – Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) PART 2B – Regulatory Agencies’ Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)

Nicoletta Bivi, Danielle L. Graham, Laura Joglekar, Kristina McGuire et autres

The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest …

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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization

Giane Sumner, Steve A. Keller, James W. Huleatt, Roland F. Staack et autres

The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place in Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in …

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Table S1 from A Novel GUCY2C-CD3 T-Cell Engaging Bispecific Construct (PF-07062119) for the Treatment of Gastrointestinal Cancers

Divya Mathur, Adam R. Root, Bozena Bugaj‐Gaweda, Stephanie Bisulco et autres

Immunohistochemistry based H-scores for GUCY2C cell surface expression in human colorectal, gastric, esophageal and pancreatic cancer

Supplementary Methods from A Novel GUCY2C-CD3 T-Cell Engaging Bispecific Construct (PF-07062119) for the Treatment of Gastrointestinal Cancers

Divya Mathur, Adam R. Root, Bozena Bugaj‐Gaweda, Stephanie Bisulco et autres

Supplementary Methods

Table S2 from A Novel GUCY2C-CD3 T-Cell Engaging Bispecific Construct (PF-07062119) for the Treatment of Gastrointestinal Cancers

Divya Mathur, Adam R. Root, Bozena Bugaj‐Gaweda, Stephanie Bisulco et autres

Table S2. Surface Plasmon Resonance binding affinities of anti-GUCY2C/anti-CD3ε bispecifics to human, mouse and cynomolgus GUCY2C

Figure S2 from A Novel GUCY2C-CD3 T-Cell Engaging Bispecific Construct (PF-07062119) for the Treatment of Gastrointestinal Cancers

Divya Mathur, Adam R. Root, Bozena Bugaj‐Gaweda, Stephanie Bisulco et autres

Mouse body weights of LS1034 tumor bearing mice treated with GUCY2C(M)-CD3 using adoptive T cell transfer

Figure S1 from A Novel GUCY2C-CD3 T-Cell Engaging Bispecific Construct (PF-07062119) for the Treatment of Gastrointestinal Cancers

Divya Mathur, Adam R. Root, Bozena Bugaj‐Gaweda, Stephanie Bisulco et autres

GUCY2C expression in non-intestinal human tissues

Figure S7 from A Novel GUCY2C-CD3 T-Cell Engaging Bispecific Construct (PF-07062119) for the Treatment of Gastrointestinal Cancers

Divya Mathur, Adam R. Root, Bozena Bugaj‐Gaweda, Stephanie Bisulco et autres

PF-07062119 binds to Cynomolgus Monkey T cells

Figure S8 from A Novel GUCY2C-CD3 T-Cell Engaging Bispecific Construct (PF-07062119) for the Treatment of Gastrointestinal Cancers

Divya Mathur, Adam R. Root, Bozena Bugaj‐Gaweda, Stephanie Bisulco et autres

Toxicity and pharmacokinetic evaluation with PF-07062119 in cynomolgus monkeys

Figure S4 from A Novel GUCY2C-CD3 T-Cell Engaging Bispecific Construct (PF-07062119) for the Treatment of Gastrointestinal Cancers

Divya Mathur, Adam R. Root, Bozena Bugaj‐Gaweda, Stephanie Bisulco et autres

cGMP assay to test GUCY2C pathway agonism and neutralization