Drugs / BNT111
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02410733 | Mar 2015 → Jun 2023 | melanoma | BioNTech SE | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT04526899 | May 2021 → Jan 2024 | melanoma | BioNTech SE | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-07-30 | BioNTech SE | Results BioNTech Announces Positive Topline Phase 2 Results for mRNA Immunotherapy Candidate BNT111 in Patients with Advanced Melanoma biontech.com ↗
The trial met its primary efficacy outcome measure, demonstrating a statistically significant improvement in ORR in patients treated with BNT111 in combination with cemiplimab as compared to historical control in this indication and treatment setting. |
| 2021-11-19 | BioNTech SE | Regulatory BioNTech Receives FDA Fast Track Designation for its FixVac Candidate BNT111 in Advanced Melanoma biontech.com ↗
BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. |
| 2021-10-01 | BioNTech SE | Results BioNTech to Present New Clinical and Preclinical Data Across Multiple Immuno-Oncology Programs at 36th SITC Annual Meeting biontech.com ↗
An RNA lipoplex (RNA-LPX) vaccine demonstrates strong immunogenicity and promising clinical activity in a Phase I trial in cutaneous melanoma patients with no evidence of disease at trial inclusion |
| 2020-07-30 | BioNTech SE | Results BioNTech Publishes Data from mRNA-based BNT111 FixVac Melanoma Trial in Nature biontech.com ↗
This interim data shows that BNT111 alone and in combination with PD-1 checkpoint blockade, while being well tolerated, mediates durable objective responses in melanoma patients that had progressed after prior checkpoint blockade. |
All press releases naming this drug 5 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BNT111 | “We are testing melanoma FixVac (BNT111)-an intravenously administered liposomal RNA (RNA-LPX) vaccine, which targets four non-mutated, tumour-associated antigens that are...” PMID 32728218 ↗ Jul 2020 |
| Known as | melanoma FixVac | “We are testing melanoma FixVac (BNT111)-an intravenously administered liposomal RNA (RNA-LPX) vaccine, which targets four non-mutated, tumour-associated antigens that are...” PMID 32728218 ↗ Jul 2020 |
| Modality | Vaccine | “liposomal RNA (RNA-LPX) vaccine” PMID 32728218 ↗ Jul 2020 |
| Route | Intravenous | “intravenously administered” PMID 32728218 ↗ Jul 2020 |
| Target | TPTE | “targeting the Tumor-associated Antigens NY-ESO-1, Tyrosinase, MAGE-A3, and TPTE” NCT02410733 ↗ |