Publications by authors named "C H Fleener"
Purpose: Stimulation of effector T cells is an appealing immunotherapeutic approach in oncology. OX40 (CD134) is a costimulatory receptor expressed on activated CD4 and CD8 T cells. Induction of OX40 following antigen recognition results in enhanced T-cell activation, proliferation, and survival, and OX40 targeting shows therapeutic efficacy in preclinical studies.
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- The 2019 Workshop on Recent Issues in Bioanalysis (WRIB) held in New Orleans attracted over 1000 professionals from various sectors, including pharmaceuticals and regulatory agencies, focusing on current bioanalysis challenges and innovations.
- The event featured extensive discussions on topics like bioanalysis methods, biomarkers, and regulatory compliance, leading to the creation of a comprehensive White Paper to guide the bioanalytical community.
- The White Paper is divided into three parts, with Part 3 specifically addressing topics such as biomarker assay validation, reagent management strategies, and gene therapy challenges, while earlier parts discuss other key regulatory recommendations and method development.
The immunologic landscape of the host and tumor play key roles in determining how patients will benefit from immunotherapy, and a better understanding of these factors could help inform how well a tumor responds to treatment. Recent advances in immunotherapy and in our understanding of the immune system have revolutionized the treatment landscape for many advanced cancers. Notably, the use of immune checkpoint inhibitors has demonstrated durable responses in various malignancies.
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- The 2018 Workshop on Recent Issues in Bioanalysis was held in Philadelphia with over 900 attendees from various sectors, focusing on bioanalysis, biomarkers, and immunogenicity over five days.
- The workshop aimed to facilitate discussions on current topics in bioanalysis, including small- and large-molecule assays utilizing LCMS and other methods, and resulted in comprehensive recommendations outlined in a White Paper.
- The White Paper is divided into three parts, with Part 3 specifically addressing large molecule bioanalysis and related topics, while Parts 1 and 2 cover small molecules and hybrid approaches, respectively.
We report pharmacokinetics, pharmacodynamics, and safety of a novel anti-CD28 domain antibody antagonist (lulizumab pegol) in healthy subjects following single- or multiple-dose administration. A minimal anticipated biological effect level approach was used to select a 0.01 mg starting dose for a single-ascending-dose (SAD), double-blind, first-in-human study.
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