BNT142 / BioNTech - LARVOL DELTA

Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=73 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting | N=330 ➔ 73 | Trial completion date: Apr 2026 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor • Testicular Cancer • CLDN6

First-in-human phase I/II trial evaluating BNT142, a first-in-class mRNA encoded, bispecific antibody targeting Claudin 6 (CLDN6) and CD3, in patients (pts) with CLDN6-positive advanced solid tumors. (ASCO 2025) - P1/2 | "BNT142 demonstrated a manageable safety profile and promising anti-tumor activity at the higher DLs, with 7 RECIST 1.1 PRs in CLDN6+ ovarian cancer, a tumor usually refractory to immunotherapy. We provide the first clinical proof-of-concept for an mRNA encoded bispecific antibody. Dose optimization is ongoing."

Clinical • Metastases • P1/2 data • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN6

BioNTech to Present Progress Across Diversified Oncology Pipeline at the 2025 ASCO Annual Meeting (The Manila Times) - "Data on BNT142 from an exploratory Phase 1/2 dose finding trial...in patients with CLDN6-positive advanced solid tumors will be featured in an oral presentation...Preliminary data indicated a manageable safety profile and early signs of clinical activity, supporting scientific proof-of-concept and underscoring the potential of mRNA-encoded bispecific antibodies."

P1/2 data • Solid Tumor

Preclinical efficacy and pharmacokinetics of an RNA-encoded T cell-engaging bispecific antibody targeting human claudin 6. (PubMed, Sci Transl Med) - P1/2 | "No signs of adverse effects from BNT142 RNA-LNP administration were observed in mice or cynomolgus monkeys. On the basis of these and other findings, a phase 1/2 first-in-human clinical trial has been initiated to assess the safety and preliminary efficacy of BNT142 RNA-LNP in patients with CLDN6-positive advanced solid tumors (NCT05262530)."

Journal • PK/PD data • Preclinical • Oncology • Solid Tumor • CLDN6

Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=288 | Recruiting | Sponsor: BioNTech SE

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • CLDN6

A phase I/II dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with prospectively confirmed claudin 6-positive solid tumors. (ASCO 2023) - P1/2 | "Additional sites will be opened in Europe, USA, and Asia in 2023. Clinical trial information: NCT05262530."

Clinical • P1/2 data • Genito-urinary Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • CLDN6

ASCO 2023 Spotlight: Claudin 6 Anticipated To Shine (Issuer Direct) - "At ASCO 2023, BioNTech and TORL will present Phase 1 clinical trial data on CLDN6-targeted programs, including BNT142, BNT211, and TORL-1-23....BioNTech will present multiple updates from its CLDN portfolio, most notably an update from their CLDN-6-targeting CAR-T cell therapy, BNT211, in combination with CLDN6- encoding mRNA vaccine (CARVac) in solid tumors (poster #2518)....BioNTech will also provide a trial-in-progress update for BNT142 (mRNA vaccine encoding a CD3 x CLDN-6 bispecific, poster abstract TPS2669)....TORL Biotherapeutics will present the first clinical data from its CLDN6 ADC TORL-1-23."

P1 data • Trial status • Oncology • Solid Tumor

Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=288 | Recruiting | Sponsor: BioNTech SE | N=216 ➔ 288

Enrollment change • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • CLDN6

Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6 Positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=216 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • CLDN6

BioNTech Announces Fourth Quarter and Full Year 2021 Financial Results and Corporate Update (GlobeNewswire) - "BNT142...BioNTech plans to start a Phase 1 clinical trial for BNT142 in the first half of 2022."

New P1 trial • Oncology • Solid Tumor

Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6 Positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=216 | Not yet recruiting | Sponsor: BioNTech SE

New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • CLDN6

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

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