drugset
Drugs / BNT113
last change Jan 2026 re-read 9 days ago

BNT113

Vaccine

Developed for
cancer of unknown primary site · carcinoma · head and neck neoplasm · head and neck squamous cell carcinoma · penile cancer · uterine cervix neoplasm
Investigated by
BioNTech SE · University of Southampton

Trials 2

today NCT04534205 · Ph 2/3 NCT03418480 · Ph 1/2
201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT03418480 Apr 2017 → Nov 2023 cancer of unknown primary site, carcinoma, head and neck neoplasm, penile cancer +1 University of Southampton Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04534205 Jan 2021 → Aug 2028 expected head and neck squamous cell carcinoma BioNTech SE Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2026-01-21 BioNTech SE Regulatory BioNTech Receives FDA Fast Track Designation for mRNA Cancer Immunotherapy Candidate BNT113 in HPV16+ Head and Neck Cancer biontech.com ↗
the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to BNT113
2024-09-05 BioNTech SE Results BioNTech to Present Clinical Data Updates Across mRNA and Immunomodulatory Oncology Portfolio at ESMO Congress 2024 biontech.com ↗
The data show immunogenicity and antitumor activity in heavily pre-treated patients in several HPV16-positive indications, including head and neck cancer, and a manageable safety profile.

All press releases naming this drug 2 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as BNT113 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04534205 ↗
1

NCT03418480 ↗
Modality Vaccine “HPV Anti-CD40 RNA vaccinE” NCT03418480 ↗
Route Intravenous “Intravenous vaccine” NCT03418480 ↗