A patient may have pre-existing antibodies (PEXA) to a therapeutic, which can impact the immune response to the drug in question. In this paper, we discuss the nature of PEXAs, how they can be detected and characterized, and how sponsors should proceed when they are present.
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Monoclonal antibodies and next-generation molecules such as antibody-drug conjugates (ADC) are being developed and moved into early-phase clinical testing. In this study, we detect Pre-Existing Antibodies (PEXA) using a homogenous MesoScale assay.
Frontage develops a full validation of the XTMAB-16 NAb (neutralizing antibody) assay with acceptable drug and target tolerances to guide future clinical trials.
This study is aimed at developing a Nanoemulsion formulation of a poorly water-soluble and thermally, oxidatively, and photolytically unstable active pharmaceutical ingredient (API) for ophthalmic application, specifically for the reduction of intraocular pressure (IOP) and to provide neuroprotection.