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Article History

Received: 8 December 2025

Accepted: 12 May 2026

First Online: 21 May 2026

Declarations

:

: Gender-pooled human K3EDTA plasma (Catalog No. HUMANPLK3-0103451, Lot HMN1362972; BioIVT) was used in this study. Plasma was obtained under an Institutional Review Board (IRB)-approved protocol (WCG IRB, Protocol No. 2010-017, IRB Tracking No. 20161665), with prospective collection of biological specimens from consenting donors for research purposes. All procedures complied with ethical guidelines for human subject research.All animal studies were conducted under institutional and national regulations for the care and use of laboratory animals. PDX and CDX studies were approved by Charles River Laboratories (Regierungspräsidium Freiburg) and Biocytogen IACUC (Beijing). Cynomolgus monkey toxicity studies were performed in an AAALAC-accredited, GLP-compliant facility, in accordance with EU Directive 2010/63/EU and French decree No. 2013-118, and authorized under APAFIS #2015122215443923. All procedures adhered to ARRIVE guidelines.

: Not applicable.

: Authors IV, LKS, IP, FJ, TS, EK, KR, UM, RS were employed by SOTIO Biotech a.s. Authors LB, LW, RB were employed by NBE-Therapeutics AG. Authors IV, LKS, UM, LB, LW and RB are inventors of the patent covering the Claudin 18.2 antibody-drug conjugate which is described in the manuscript. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.