Drugs / Autogene cevumeran
Autogene cevumeran
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | Other | — | — | 2021-05-10 | “These data are required to address the partial clinical hold on the subsequent randomized part of the Phase 2 trial.” biontech.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04161755 | Dec 2019 → Nov 2026 expected | malignant pancreatic neoplasm | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03289962 | Dec 2017 → Jul 2025 | colorectal cancer, head and neck cancer, kidney cancer, melanoma +3 | Genentech, Inc. | Completed | No outcome recorded |
| Phase 25 trials · 1 missed | ||||||
| Phase 2 | NCT06534983 | Dec 2024 → Nov 2027 expected | urothelial carcinoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT05968326 | Oct 2023 → Jan 2031 expected | pancreatic ductal adenocarcinoma | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04267237 | Mar 2021 → Sep 2025 | non-small cell lung carcinoma | Hoffmann-La Roche | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04486378 | Mar 2021 → Nov 2026 expected | colorectal cancer | BioNTech SE | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03815058 | Dec 2018 → Jan 2025 | melanoma | Genentech, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2024-04-07 | BioNTech SE | Results Three-year Phase 1 Follow-Up Data for mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Some Patients with Resected Pancreatic Cancer biontech.com ↗
The data show that in 8 out of 16 patients autogene cevumeran elicited an immune response up to three years post administration measured by activated T cells. |
All press releases naming this drug 1 release
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Autogene cevumeran | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03289962 ↗ |
| Known as | BNT-122 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650376 ↗ |
| Known as | RG 6180 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650376 ↗ |
| Known as | RO7198457 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04486378 ↗ |
| Modality | Messenger RNA (mRNA) | “Autogene cevumeran is a uridine messenger RNA lipoplex-based individualized neoantigen-specific immunotherapy” PMID 39762422 ↗ Jan 2025 |
| Route | Intravenous | “administered by intravenous (IV) infusion” NCT03289962 ↗ |