BNT3216 / BioNTech - LARVOL DELTA

A phase I/II dose-escalation and expansion trial of BNT3216 (PM1032), an anti-CLDN18.2 and 4-1BB bispecific antibody, in patients (pts) with advanced gastrointestinal (GI) cancers (ESMO-GI 2026) - P1/2 | "Conclusions BNT3216 demonstrated acceptable tolerability at doses up to 15 mg/kg and promising antitumor activity in pts with advanced GC/GEJC and PC. Clinical benefit was observed in the CLDN18.2+ GC/PC population; data from a larger sample size are required to support these findings."

Bispecific • Clinical • IO biomarker • Metastases • P1/2 data • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • CLDN18

First-in-human phase I/II safety and preliminary efficacy of PM1032, a bispecific antibody targeting CLDN18.2 and 4-1BB, in patients with advanced solid tumors. (ASCO 2024) - P1/2 | "PM1032 was well-tolerated up to 12 mg/kg Q2W and demonstrated preliminary anti-tumor activity in CLDN18.2+ tumors. Further development of PM1032 as a monotherapy and/or combination therapy for CLDN18.2-positive cancers is planned."

Clinical • IO biomarker • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

Safety and Pharmacokinetic Assessment of the FIC CLDN18.2/4-1BB Bispecific Antibody in Rhesus Monkeys. (PubMed, Int J Toxicol) - "Zolbetuximab, a first-in-class investigational monoclonal antibody (mAb) targeting tumor-associated antigen CLDN18.2 which is highly expressed on gastric cancer cells, was recently reported to meet the primary endpoint in Phase III trial as first-line treatment in CLDN18.2 positive and HER2-negative gastric cancers. Furthermore, PM1032 was generally well tolerated, with no significant abnormalities observed in toxicity studies, including the liver and stomach. In summary, PM1032 demonstrated good PK and an exceptional safety profile in rhesus monkeys supporting further investigation in clinical studies."

Journal • PK/PD data • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Solid Tumor • CLDN18 • HER-2

Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Biotheus Inc.

New P1/2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18