Evidence map›Paper›PMID 37860278›Full record

ArticleOncoimmunology2023

Preclinical characterization of an mRNA-encoded anti-Claudin 18.2 antibody.

Hayat Bähr-Mahmud, Ursula Ellinghaus, Christiane R Stadler, Leyla Fischer, Claudia Lindemann, Anuhar Chaturvedi, Jan Diekmann, Stefan Wöll, Imke Biermann, Bernhard Hebich and 8 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Oncoimmunology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04683939 (Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT141 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With CLDN18.2-positive Solid Tumors), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
8.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04683939 phase1 / phase2terminatednot on this map

Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT141 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With CLDN18.2-positive Solid Tumors

TypeinterventionalSponsorBioNTech SERan2022 to 2023Enrolled13ConditionsSolid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal AdenocarcinomaArmsBNT141, Nab-paclitaxel, Gemcitabine
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 26 citations in OpenAlex.

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  16. Molecular therapy. Nucleic acids · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 2 institutions in 1 country.

Hayat Bähr-MahmudBioNTech SE, Mainz, Germany.
Ursula EllinghausBioNTech SE, Mainz, Germany.
Christiane R StadlerBioNTech SE, Mainz, Germany.
Leyla FischerBioNTech SE, Mainz, Germany.
Claudia LindemannBioNTech SE, Mainz, Germany.ORCID 0000-0002-6987-2398
Anuhar ChaturvediBioNTech SE, Mainz, Germany.ORCID 0000-0002-9597-3010
Jan DiekmannBioNTech SE, Mainz, Germany.
Stefan WöllBioNTech SE, Mainz, Germany.
Imke BiermannBioNTech SE, Mainz, Germany.
Bernhard HebichBioNTech SE, Mainz, Germany.
Caroline ScharfBioNTech SE, Mainz, Germany.
Manuela SiefkeBioNTech SE, Mainz, Germany.
Alexandra S RothBioNTech SE, Mainz, Germany.
Martin RaoBioNTech SE, Mainz, Germany.ORCID 0000-0002-0579-1097
Kerstin BrettschneiderBioNTech SE, Mainz, Germany.
Eva-Maria EwenBioNTech SE, Mainz, Germany.
Uğur ŞahinBioNTech SE, Mainz, Germany.ORCID 0000-0003-0363-1564
Özlem TüreciBioNTech SE, Mainz, Germany.
BioNTech (Germany) · DEJohannes Gutenberg University Mainz · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

IMAB362/Zolbetuximab, a first-in-class IgG1 antibody directed against the cancer-associated gastric-lineage marker CLDN18.2, has recently been reported to have met its primary endpoint in two phase 3 trials as a first-line treatment in combination with standard of care chemotherapy in CLDN18.2-positive Her2 negative advanced gastric cancer. Here we characterize the preclinical pharmacology of BNT141, a nucleoside-modified RNA therapeutic encoding the sequence of IMAB362/Zolbetuximab, formulated in lipid nanoparticles (LNP) for liver uptake. We show that the mRNA-encoded antibody displays a stable pharmacokinetic profile in preclinical animal models, mediates CLDN18.2-restricted cytotoxicity comparable to IMAB362 recombinant protein and inhibits human tumor xenograft growth in immunocompromised mice. BNT141 administration did not perpetrate mortality, clinical signs of toxicity, or gastric pathology in animal studies. A phase 1/2 clinical trial with BNT141 mRNA-LNP has been initiated in advanced CLDN18.2-expressing solid cancers (NCT04683939).

Indexed as

Stomach NeoplasmsAnimalsAntibodiesCell Adhesion MoleculesClaudinsHumansMiceRNA, MessengerAntibodiesCell Adhesion MoleculesClaudinsCLDN18 protein, humanRNA, MessengerADCCBNT141human CLDN18.2IMAB362immunotherapyRiboMabRNA therapeuticssolid tumorZolbetuximab

Identifiers

PMID37860278
PMCPMC10583639
OpenAlexW4387694998

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.