Safety assessment of fluorescently labeled anti-EGFR Nanobodies in healthy dogs

荧光标记抗EGFR纳米抗体在健康犬中的安全性评估

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作者:Nayra Cristina Herreira do Valle, Simone Janssen, Marcus C M Stroet, Sofie Pollenus, Sonja Van den Block, Nick Devoogdt, Jens M Debacker, Sophie Hernot #, Hilde De Rooster #

Discussion

These are the first results to indicate that 7D12-s775z is well tolerated in dogs and paves the way to conduct clinical trials in canine patients with EGFR-overexpressing spontaneous tumors.

Methods

To determine the safety profile of the study drug, three healthy purpose-bred dogs received an intravenous injection of the tracer at 5.83, 11.66, and 19.47 mg/m2, separated by a 14-day wash-out period. Physical examination and fluorescence imaging were performed at established time points, and the animals were closely monitored between doses. Blood and urine values were analyzed pre- and 24 h post administration.

Results

No adverse effects were observed, and blood and urine values stayed within the reference range. Images of the oral mucosa, acquired with a fluorescence imaging device (Fluobeam®), suggest rapid clearance, which was in accordance with previous in vivo studies.

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