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BNT113

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

BioNTech SE BNTX · Metastatic Head and Neck Cancer; Recurrent Head and Neck Cancer; Unresectable Head and Neck Squamous Cell Carcinoma

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 2/3

    Not recorded

  • Linked trials

    1

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
BioNTech SE BNTX Source: Company record for BioNTech SE (opens in a new tab)
Indications
Metastatic Head and Neck Cancer; Recurrent Head and Neck Cancer; Unresectable Head and Neck Squamous Cell Carcinoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Current stageFirst trial start 7 Jan 20211 linked trial
  4. Phase 3 Current stageFirst trial start 7 Jan 20211 linked trial
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for BNT113. Editors add each one with its source.

Filed application

No filed application is on record for BNT113. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for BNT113.

Clinical trials

Trials linked to BNT113
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT04534205ClinicalTrials.gov record for NCT04534205 (opens in a new tab)AHEAD-MERITA Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1Phase 2/3Active, not recruiting358 (actual)Apr 2029 (estimated) No

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

No FDA approvals on record for this drug.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as BNT113.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.