Steven Eck
A5054978978- Monoclonal and Polyclonal Antibodies Research
- Cancer Immunotherapy and Biomarkers
- Immunotherapy and Immune Responses
- T-cell and B-cell Immunology
- CAR-T cell therapy research
- Biosimilars and Bioanalytical Methods
- Cell Image Analysis Techniques
- Radiopharmaceutical Chemistry and Applications
- Immune Cell Function and Interaction
- Single-cell and spatial transcriptomics
- Cancer, Hypoxia, and Metabolism
- Chronic Lymphocytic Leukemia Research
- Galectins and Cancer Biology
- Glycosylation and Glycoproteins Research
- Immunodeficiency and Autoimmune Disorders
- Lymphoma Diagnosis and Treatment
- Immune cells in cancer
- Biosensors and Analytical Detection
- Nanoparticle-Based Drug Delivery
- Chemical Reactions and Isotopes
- Statistical Methods in Clinical Trials
- Cancer Cells and Metastasis
- Synthesis and Biological Evaluation
- Inflammatory mediators and NSAID effects
- Animal Disease Management and Epidemiology
AstraZeneca (United States)
2019-2025
AstraZeneca (Brazil)
2025
Pfizer (United States)
2006
University of Pennsylvania
1997-2006
Abstract Background CD73 upregulation in tumors leads to local immunosuppression. This phase I, first-in-human study evaluated oleclumab (MEDI9447), an anti-CD73 human IgG1λ monoclonal antibody, alone or with durvalumab patients advanced colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), epidermal growth factor receptor-mutant non-small-cell lung (NSCLC). Methods Patients received 5–40 mg/kg (dose-escalation) 40 (dose-expansion) intravenously every 2 weeks (Q2W), (escalation...
VIB4920, a nonantibody scaffold protein, blocks CD40L and reduces autoantibodies disease activity in patients with rheumatoid arthritis.
Immune checkpoint blockade has demonstrated clinical benefits across multiple solid tumor types; however, resistance and relapse often occur. New immunomodulatory targets, which are highly expressed in activated immune cells, needed. MEDI0562, an agonistic humanized mAb, specifically binds to the costimulatory molecule OX40. This first-in-human study evaluated MEDI0562 adults with advanced tumors.In this phase I, multicenter, open-label, single-arm, dose-escalation (3+3 design) study,...
Analytical method validation provides a means to ensure that data are credible and reproducible. This unit will provide brief introduction analytical as applied cellular analysis by flow cytometry. In addition, the practical procedures for three different types of validation. The first is limited protocol applicable research settings non-regulated laboratories. second presents minimum requirements in regulated third transfer be used when methods transferred between recommendations presented...
The 17
Abstract Background Management of patients with small bowel Crohn’s disease (SBCD) remains challenging due to limited efficacy from current therapeutic options. AZD7798 is a first-in-class monoclonal antibody for CD that depletes CCR9+ lymphocytes, potential targeted treatment SBCD given the critical role CCR9 plays in lymphocyte homing bowel. Monitoring cell depletion and repletion blood straightforward, but difficult accessibility biopsy. Here we use positron emission tomography (PET)...
Abstract Background Crohn’s disease (CD) can affect any part of the gastrointestinal tract, but about 30% patients have inflammation restricted to ileum. In clinical trials, are typically enrolled irrespective localisation, with outcomes focusing on a broad patient population. Anecdotally, small bowel healing in CD is often reported as challenging. Our aims were investigate unmet need treating ileal and explore potential drug targets for this subpopulation. Methods A systematic review...
The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place San Antonio, TX, USA 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 bioanalysis. WRIB included 3 Main Workshops 7 Specialized that together spanned 1 week allow an exhaustive thorough coverage all major issues bioanalysis biomarkers, immunogenicity, gene therapy, cell therapy vaccines....
Objectives: Volrustomig (MEDI5752) is a monovalent bispecific antibody (DuetMab) with an Fc-domain engineered to reduce effector function, targeting two clinically validated negative T cell regulators, Programmed death 1 (PD-1) and cytotoxic T-lymphocyte-associated protein-4 (CTLA-4). The has been designed suppress the PD-1 pathway provide enhanced CTLA4 inhibition in context of PD1 expression, such as PD1+/CTLA4+ activated cells. Our goal was develop validate dual TMDD model by...
Abstract Ligation of OX40 (CD134, TNFRSF4) on activated T cells by its natural ligand (OX40L, CD252, TNFSF4) enhances cellular survival, proliferation, and effector functions such as cytokine release cytotoxicity. We engineered a recombinant human OX40L IgG4P Fc fusion protein termed MEDI6383 that assembles into hexameric structure exerts potent agonist activity following engagement OX40. displayed solution-phase was enhanced when the clustered gamma receptors (FcγRs) surface adjacent cells....
Abstract The current consensus recommendation papers dealing with the unique requirements for analytical validation of assays performed by flow cytometry address sensitivity (both and functional) only in general terms. In this paper, a detailed approach designing validating rare event methods is described. impact panel design optimization on lower limit quantification (LLOQ) suggestions reporting data near, or below, LLOQ are addressed. This paper serves to provide best practices...
Abstract Analytical method validation provides a means to ensure that data are credible and reproducible. This article will provide brief introduction analytical as applied cellular analysis by flow cytometry, along with practical procedures for four different types of validation. The first, Basic Protocol 1 (the limited protocol), is recommended research non‐regulated laboratories. Next, 2) presents reasonable, fit‐for‐purpose approach appropriate biopharma settings. 3 addresses the type...
The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually June 15-29, 2020 with an attendance over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations, and regulatory agencies worldwide. WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days order to allow exhaustive thorough coverage all major issues bioanalysis, biomarkers, immunogenicity, gene...
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held 27 September to 1 October 2021. Even with a last-minute move from in-person virtual, an overwhelmingly high number nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), multiple regulatory agencies still eagerly convened actively discuss most current topics interest bioanalysis. WRIB included three Main Workshops seven Specialized that together spanned...
The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place Atlanta, GA, USA 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 bioanalysis. WRIB included 3 Main Workshops 7 Specialized that together spanned 1 week order allow exhaustive thorough coverage all major issues bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy...
Objective Immune complexes (ICs) play a critical role in the pathology of autoimmune diseases. The aim this study was to generate and characterise first-in-class anti-FcγRIIA antibody (Ab) VIB9600 (previously known as MEDI9600) that blocks IgG immune complex-mediated cellular activation for clinical development. Methods humanised optimised from IV.3 Ab. Binding affinity specificity were determined by Biacore ELISA. Confocal microscopy, Flow Cytometry-based assays binding competition used...
Introduction: Cyt-Geist: Current and Future Challenges in Cytometry 601 Chapter 01: Trends 01 Introduction WS18: Flow Drivers WS06: the Era of Human Cell Atlas 000 WS07: CYTO Lab Hacks: Inspiring Innovation Through Open Collaboration 605 WS15: The Status Microbiome 607 Conclusion 610 02: Shared Resource Laboratory (SRL) Best Practices 02 WS01: Balancing Science Service a 611 WS02: A Successful Imaging Facility: Guidelines for Management Publication 613 WS05: Identification Areas Where...
Abstract Background: IL-12 is a key mediator of antitumor immune response. In preclinical models, IT mRNA led to IFNγ release and CD8+ T cell-dependent tumor regression potentiated PD-L1 blockade. MEDI1191, lipid nanoparticle-formulated encoding delivered by injection, drives production enhances response with improved tolerability. We hypothesized that combining MEDI1191 blockade would augment immunity in vivo. Here we report updated results from the dose-escalation phase first-in-human...
To determine activation status of the IL-2R-associated (Jak/STAT) pathway in HTLV-I infected cells, we examined tyrosine phosphorylation Jak3, STAT3, and STAT5 several (+) T-cell lines uncultured leukemic T cells isolated from patients with adult lymphoma/leukemia (ATLL). Constitutive basal Jak3 and, usually, STAT3 was detected all four IL-2-independent cell tested, but none three IL-2-dependent lines. Similarly, there no detectable ATLL (0/8 0/3, respectively). However, stimulation IL-2...
Physiologically relevant full activation of T cells requires signal transduction through the cell receptor and additional costimulatory surface molecules. Best understood these interactions are those between CD28 its ligands B7-1 (CD80) B7-2 (CD86). While bind same receptors (CD28 CTLA-4), they share only 25% sequence homology, expressed at different times during immune responses, in some systems have been shown to differentially affect cytokine expression. Although is an antigen, expression...
Abstract Background: Volrustomig (MEDI5752) is designed to fully inhibit PD-1 while preferentially inhibiting CTLA-4 on activated PD-1+ T cells. In a FTiH trial, volrustomig demonstrated meaningful clinical activity in patients with solid tumors (including 1L RCC and NSCLC), acceptable safety profile, sustained receptor occupancy, cell proliferation at levels greater than seen clinically tolerable doses of inhibitors co-administration anti-PD(L)-1. We sought further characterize...
The Clinical and Laboratory Standards Institute (CLSI) H62-Validation of Assays Performed by Flow Cytometry guideline, released in 2021, provides recommendations for platform workflow quality system essentials, instrument setup standardization, assay development optimization fit-for-purpose analytical method validation. In addition, CLSI H62 includes some the validation strategies after a validated flow cytometric has been modified. This manuscript builds on those discusses impact different...
Abstract This conference report summarized a full-day workshop, “best practices for the development and fit-for-purpose validation of biomarker methods,” which was held prior to American Association Pharmaceutical Scientists (AAPS) PharmSci360 Congress, San Antonio, TX, November 2019. The purpose workshop bring together thought leaders in assay order identify parameters key statistical measures need be considered when developing assay. A diverse group more than 40 scientists participated...