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    DRUG:

    BNT111

    i
    Other names: BNT111, tetravalent RNA-lipoplex cancer vaccine, RBL 001/RBL 002/RBL 003/RBL 004, RBL001.1/RBL002.2/RBL003.1/RBL004.1, RNA-LPX, RNA(LIP), RNA-LP, RNA-lipoplex, Lipo-MERIT, Lipo-MERIT FixVAC, RB 0003, Lipo-MERIT vaccine, RBL001/RBL002/RBL003/RBL004, BNT-111, BNT 111
    Company:
    BioNTech
    Drug class:
    Immunostimulant, NY ESO 1 inhibitor, MAGE-A3 inhibitor, Protein tyrosine phosphatase inhibitor, Tyrosinase inhibitor
    Related drugs:
    3ms
    BNT111-01: Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma (clinicaltrials.gov)
    P2, N=184, Active, not recruiting, BioNTech SE | Trial primary completion date: Nov 2025 --> Jan 2024
    Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    Libtayo (cemiplimab-rwlc) • BNT111
    5ms
    Expression of the tumor antigens NY-ESO-1, tyrosinase, MAGE-A3, and TPTE in pediatric and adult melanoma: a retrospective case control study. (PubMed, Virchows Arch)
    BNT111, an investigational lipoplex-formulated mRNA-based therapeutic cancer vaccine encoding melanoma TAAs NY-ESO-1, tyrosinase, MAGE-A3, and TPTE, is undergoing clinical testing in adults. All four TAAs were expressed in pediatric melanoma, albeit NY-ESO-1 and MAGE-A3 to a lesser extent than in adult melanoma. These data support the possibility of investigating vaccines targeting these TAAs for the treatment of pediatric melanoma.
    Retrospective data • Journal • IO biomarker
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    BNT111
    1year
    Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma (clinicaltrials.gov)
    P2, N=184, Active, not recruiting, BioNTech SE | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Libtayo (cemiplimab-rwlc) • BNT111
    over1year
    Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma (clinicaltrials.gov)
    P2, N=180, Recruiting, BioNTech SE | Trial completion date: Jun 2025 --> Jul 2026 | Trial primary completion date: Oct 2024 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Libtayo (cemiplimab-rwlc) • BNT111
    over1year
    Lipo-MERIT: Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma (clinicaltrials.gov)
    P1, N=119, Completed, BioNTech SE | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    BNT111
    over2years
    Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma (clinicaltrials.gov)
    P2, N=180, Recruiting, BioNTech SE | Trial completion date: Dec 2023 --> Jun 2025 | Trial primary completion date: May 2022 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Libtayo (cemiplimab-rwlc) • BNT111
    almost3years
    Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma (clinicaltrials.gov)
    P2, N=180, Recruiting, BioNTech SE | N=120 --> 180
    Clinical • Enrollment change
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Libtayo (cemiplimab-rwlc) • BNT111
    3years
    Lipo-MERIT: Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma (clinicaltrials.gov)
    P1, N=119, Active, not recruiting, BioNTech RNA Pharmaceuticals GmbH | Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Dec 2021 --> May 2023
    Clinical • Trial completion date • Trial primary completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    BNT111
    over3years
    Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma (clinicaltrials.gov)
    P2, N=120, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Libtayo (cemiplimab-rwlc) • BNT111
    almost4years
    Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, BioNTech SE | Initiation date: Nov 2020 --> Mar 2021
    Clinical • Trial initiation date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Libtayo (cemiplimab-rwlc) • BNT111
    4years
    An RNA vaccine drives immunity in checkpoint-inhibitor-treated melanoma. (PubMed, Nature)
    We are testing melanoma FixVac (BNT111)-an intravenously administered liposomal RNA (RNA-LPX) vaccine, which targets four non-mutated, tumour-associated antigens that are prevalent in melanoma-in an ongoing, first-in-human, dose-escalation phase I trial in patients with advanced melanoma (Lipo-MERIT trial, ClinicalTrials.gov identifier NCT02410733)...The antigen-specific cytotoxic T-cell responses in some responders reach magnitudes typically reported for adoptive T-cell therapy, and are durable. Our findings indicate that RNA-LPX vaccination is a potent immunotherapy in patients with CPI-experienced melanoma, and suggest the general utility of non-mutant shared tumour antigens as targets for cancer vaccination.
    Clinical Trial,Phase I • Journal • Checkpoint inhibition • PD(L)-1 Biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    BNT111
    4years
    Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, BioNTech SE
    Clinical • New P2 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Libtayo (cemiplimab-rwlc) • BNT111