BNT116 (Non-Small Cell Lung Cancer Vaccine) — Pipeline & Regulatory Status

Development Phase Phase 1 Clinical Trial Primary Status

Platform Technology Biological (unspecified platform) Biologic Architecture

Target Indication Non-Small Cell Lung Cancer Pathogen / Antigen

Last Verified 2026-07-10 Tier 1 Multi-Source Checked

Multi-Jurisdiction Regulatory Status

Official licensing, rolling submissions, or authorization status tracked across major health authorities.

Regulatory Authority	Status & Details
US FDA	Not Filed / Pre-submission
EMA (Europe)	Not Filed / Pre-submission
Health Canada	Not Filed / Pre-submission
TGA (Australia)	Not Filed / Pre-submission

Scientific Profile & Documentation

Platform Architecture: Biological (unspecified platform)
Lead Developer: BioNTech SE
Next Expected Milestone: Primary completion (most advanced trial): 2030-02 (registry estimate)
Analyst & Development Notes: Auto-grouped from 1 ClinicalTrials.gov record(s) sharing intervention/sponsor. Phases and timelines are registry fields and may lag company disclosures.
Primary Source Documentation: ClinicalTrials.gov NCT05142189 →

Registered Clinical Trials & Studies

Direct registry links to active, completed, or pivotal registration studies across phases.

NCT05142189 Phase 1 Clinical Trial

Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patie

Status: Active / Ongoing • Expected Readout: 2030-02

Milestone Overview

Stage Verification

Phase 1 Clinical Trial confirmed as of 2026-07-10.
Target Milestone

Primary completion (most advanced trial): 2030-02 (registry estimate)

Vaccine Data Navigator Candidate Profile Registry:

This candidate profile is indexed across all clinical development levels (Preclinical through Phase 1–3, Regulatory Filing, and Licensure) from primary registry databases (ClinicalTrials.gov, WHO ICTRP, FDA CBER, EMA, Health Canada, TGA Australia). Data are updated continuously to track global biologic and vaccine pipelines.