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BioWorld - Monday, December 29, 2025
Home » CLDN18.2

Articles Tagged with ''CLDN18.2''

Illustration of cancer tumor on pancreas

Astellas’ zolbetuximab misses pancreatic cancer phase II endpoint

Oct. 14, 2025
By Marian (YoonJee) Chu
No Comments
Astellas Pharma Inc. reported Oct. 14 that its CLDN18.2-targeting monoclonal antibody, zolbetuximab (Vyloy), did not meet the primary endpoint of overall survival in the phase II Gleam trial of patients with advanced pancreatic cancer.
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3D illustration of T cells fighting cancer
Immuno-oncology

Xilio advances masked T-cell engagers targeting PSMA, CLDN18.2 and STEAP1

Feb. 13, 2025
Xilio Therapeutics Inc. has announced three wholly owned preclinical programs for masked T-cell engagers targeting prostate-specific membrane antigen (PSMA), claudin 18.2 (CLDN18.2) and six-transmembrane epithelial antigen of prostate 1 (STEAP1).
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3D rendering conceptualizing theranostics
Diagnostics

Peptidream announces new peptide radiopharmaceutical development candidate targeting CLDN12.8

Dec. 13, 2024
Peptidream Inc. has announced a new peptide radiopharmaceutical development candidate, PD-29875, a novel first-in-class highly selective macrocyclic peptide-radioisotope conjugate against Claudin 18.2 (CLDN18.2).
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Immuno-oncology

Bolt presents immune-stimulating antibody-drug conjugate

Nov. 14, 2024
Claudin (CLDN) 18.2 is a transmembrane tight junction protein overexpressed in multiple cancers, including gastric, esophageal and pancreatic cancers.
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US FDA issues first-in-class and first-line approval for Astellas’ Vyloy

Oct. 22, 2024
By Karen Carey
Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
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US FDA issues first-in-class and first-line approval for Astellas’ Vyloy

Oct. 18, 2024
By Karen Carey
Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
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EU flags in front of the Berlaymont building

A CHMP thumbs up for Astellas’ Claudin18.2 zolbetuximab

July 30, 2024
By Tamra Sami
Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
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EU flags in front of the Berlaymont building

A CHMP thumbs up for Astellas’ Claudin18.2 zolbetuximab

July 29, 2024
By Tamra Sami
Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
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Green approved stamp

Astellas wins first approval of Vyloy in gastric cancer in Japan

April 2, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
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Green approved stamp

Astellas wins first approval of Vyloy in gastric cancer in Japan

March 27, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
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