Publications by authors named "S A Irvin"
The ADA testing strategy for protein therapeutics was established almost two decades ago when assay methodologies were rudimentary, and serious immunogenicity-related safety issues had recently been observed with some biotherapeutics. The current testing paradigm employs multiple tiers and stringent cut points to minimize false negatives, reflecting a conservative stance towards ADA analysis. The development of highly sensitive ADA assay platforms and technologies such as humanized or fully human monoclonal antibody (mAb) drugs has put the traditional, resource-intensive 3-tiered testing approach under scrutiny.
View Article and Find Full Text PDFOvarian cancer is the fifth leading cause of cancer related death in the United States. Cisplatin is a platinum-based anti-cancer drug used against ovarian cancer that enters malignant cells and then damages DNA causing cell death. Typically, ovarian cancer cells become resistant to cisplatin making it necessary to increase subsequent dosage, which usually leads to side-effects including irreversible damage to kidney and auditory system tissue.
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- Pregnant women with COVID-19 are at higher risk for severe outcomes, and this study evaluated the safety and effectiveness of the monoclonal antibody treatment CAS+IMD in this population.* -
- The study, which involved 82 pregnant participants, found that CAS+IMD was well tolerated with minimal adverse reactions, and it effectively reduced viral loads without significantly affecting fetal development.* -
- Overall, the treatment showed promising safety and efficacy, suggesting it could be a viable option for managing COVID-19 in pregnant women, although conclusions about its effects are limited due to a small number of placebo recipients.*
Safety and Pharmacokinetics of Casirivimab and Imdevimab (CAS + IMD) in Pediatric Outpatients With COVID-19.
J Pediatric Infect Dis Soc
November 2024
Article Synopsis
- A clinical trial assessed the safety of the combination of casirivimab and imdevimab (CAS + IMD) in children with COVID-19.
- The results showed that the treatment was well tolerated, similar to findings in adults, with minimal immune response side effects.
- The study supports further development of advanced monoclonal antibodies for children at higher risk for COVID-19.
Effect of timing of casirivimab and imdevimab administration relative to mRNA-1273 COVID-19 vaccination on vaccine-induced SARS-CoV-2 neutralising antibody responses: a prospective, open-label, phase 2, randomised controlled trial.
Lancet Infect Dis
January 2025
Background: Deeper insight is needed on how monoclonal antibodies (mAbs) affect vaccine-mediated immune responses when targeting the same protein. We describe the first prospective randomised trial designed to understand mAb-mediated alterations in vaccine-induced immune responses to SARS-CoV-2 spike protein epitopes.
Methods: This randomised, open-label, parallel-group study assessed the potential interaction of a mAb combination, casirivimab and imdevimab, with a vaccine, Moderna's mRNA-1273, in healthy SARS-CoV-2 immunologically naive, seronegative adults at six centres in the USA.