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APX005M

Discontinued / Inactive

Developer: BioNTech US Inc.  |  Target Disease: Metastatic Melanoma

Program Status: Inactive / Discontinued

Reason: Registry status: TERMINATED

Stage at discontinuation: phase_1

Development Phase Discontinued / Inactive Primary Status
Platform Technology Biological (unspecified platform) Biologic Architecture
Target Indication Metastatic Melanoma 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 US Inc.
Next Expected Milestone
Primary completion (most advanced trial): 2020-05-05 (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 NCT03597282 →

Registered Clinical Trials & Studies

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

NCT03597282 Discontinued / Inactive

A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma

Status: Active / Ongoing • Expected Readout: 2020-05-05

Milestone Overview

  • Stage Verification
    Discontinued / Inactive confirmed as of 2026-07-10.
  • Target Milestone
    Primary completion (most advanced trial): 2020-05-05 (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.