drugset
Drugs / BNT316
last change Oct 2025 re-read 3 minutes ago

BNT316

Protein / enzyme biologic

Developed for
non-small cell lung carcinoma
Investigated by
BioNTech SE

Trials 1

today NCT05142189 · Ph 1
20232024202520262027202820292030
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT05142189 Jun 2022 → Feb 2030 expected non-small cell lung carcinoma BioNTech SE Recruiting No outcome recorded

Press releases naming this drug 7 releases

DateIssuerRelease
2025-10-27 OncoC4, Inc. China’s NMPA Grants Breakthrough Therapy Designation for Anti-CTLA-4 Antibody Candidate Gotistobart (BNT316/ONC-392) oncoc4.com ↗
2025-06-03 OncoC4, Inc. ASCO 2025: PRESERVE-006: Phase 1 Study of Gotistobart (BNT316/ONC-392) in Combination with Lutetium Lu 177 Vipivotide Tetraxetan in Patients with mCRPC oncoc4.com ↗
2024-02-22 OncoC4, Inc. OncoC4 Announces First Patient with Advanced Prostate Cancer Dosed in Phase 1/2 Trial of BioNTech-partnered BNT316/ONC-392 Program oncoc4.com ↗
2023-06-29 BioNTech SE BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of BNT316/ONC-392 Program in Metastatic NSCLC biontech.com ↗
2023-06-29 OncoC4, Inc. BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of BNT316/ONC-392 Program in Metastatic NSCLC oncoc4.com ↗
2023-06-02 BioNTech SE BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO biontech.com ↗
2023-06-02 OncoC4, Inc. BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO oncoc4.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as BNT316 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05142189 ↗
Modality Protein / enzyme biologic “BNT316 (CTLA4 antibody)” NCT05142189 ↗
Route Intravenous “Intravenous infusion” NCT05142189 ↗