BNT141 / BioNTech - LARVOL DELTA

Preclinical characterization of an mRNA-encoded anti-Claudin 18.2 antibody. (PubMed, Oncoimmunology) - P1/2 | "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. 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)."

Journal • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors (clinicaltrials.gov) - P1/2 | N=13 | Terminated | Sponsor: BioNTech SE | N=96 ➔ 13 | Trial completion date: Sep 2024 ➔ Jul 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2024 ➔ Jul 2023; Sponsor decision

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

A phase I/II dose escalation and expansion trial to evaluate safety and preliminary efficacy of BNT141 in patients with claudin-18.2-positive solid tumors. (ASCO 2023) - P1/2 | "The resulting antibody is sequence identical to IMAB362, a CLDN18.2-targeted antibody that provided clinical benefit as an add-on to chemotherapy in the Phase III SPOTLIGHT trial (Shitara et al.J Clin Oncol...The trial comprises 3 parts: dose escalation with BNT141 as monotherapy, dose escalation with BNT141 in combination with nab-paclitaxel and gemcitabine, and dose expansion...Sites in Spain, Portugal, Germany, Denmark, Netherlands and the UK will be opened in 2023. Clinical trial information: NCT04683939."

Clinical • P1/2 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors (clinicaltrials.gov) - P1/2 | N=96 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Monotherapy • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

A global study to evaluate preliminary efficacy of cancer drug BNT141 in patients with unresectable or metastatic CLDN18.2-positive solid tumors (clinicaltrialsregister.eu) - P1/2 | N=154 | Ongoing | Sponsor: BioNTech SE

Combination therapy • Metastases • Monotherapy • New P1/2 trial • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gallbladder Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN18

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 (clinicaltrials.gov) - P1/2 | N=96 | Recruiting | Sponsor: BioNTech SE | N=48 ➔ 96

Combination therapy • Enrollment change • Monotherapy • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 (clinicaltrials.gov) - P1/2; N=48; Recruiting; Sponsor: BioNTech SE; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Biliary Tract Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN18

BioNTech Announces Full Year 2020 Financial Results and Corporate Update (GlobeNewswire) - “BNT141 – In February, the U.S. FDA approved the IND for a Phase 1 first-in-human clinical trial for BNT141. We expect to start the trial in the second half of 2021. BNT142 – We expect to start a Phase 1 clinical trial for BNT142 in the second half of 2021…BNT311/GEN1046 – Data from a first-in-human Phase 1/2a trial of BNT311 (PD-L1x4-1BB) in 61 heavily pretreated patients with advanced solid tumors was presented at the SITC conference in November 2020. We expect a data update from this trial in the second half of 2021.”

New P1 trial • P1/2 data • Oncology • Solid Tumor

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 (clinicaltrials.gov) - P1/2; N=48; Not yet recruiting; Sponsor: BioNTech SE

Clinical • Combination therapy • Monotherapy • New P1/2 trial • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

BioNTech announces full year 2019 financial results and corporate update (GlobeNewswire) - "BNT211 – Initiation of a Phase 1/2a trial in multiple solid tumors (CLDN6) remains on track for 1H 2020; BNT411 – U.S. IND was approved in Q4 2019. A Phase 1/2a clinical trial of BNT411 is now expected to be initiated as a mono- or combination therapy in multiple solid tumors in 2H 2020; BNT141 – Initiation of a Phase 1 trial in multiple solid tumors is now expected in 1H 2021. BNT142 – Initiation of a Phase 1 trial in multiple solid tumors (CD3+CLDN6) is now expected in 1H 2021."

IND • New P1 trial • New P1/2 trial • Oncology • Solid Tumor