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    DRUG:

    BNT111

    i
    Other names: 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, BNT111, tetravalent RNA-lipoplex cancer vaccine, RBL 001/RBL 002/RBL 003/RBL 004, RBL001.1/RBL002.2/RBL003.1/RBL004.1
    Company:
    BioNTech
    Drug class:
    Immunostimulant, NY ESO 1 inhibitor, MAGE-A3 inhibitor, Protein tyrosine phosphatase inhibitor, Tyrosinase inhibitor
    Related drugs:
    2d
    Biomimetic and personalized nanovaccines in cancer immunotherapy: Design innovations, translational challenges, and future directions. (PubMed, J Adv Res)
    This review synthesizes recent advances in biomimetic and personalized nanovaccine design, highlighting clinical progress in lipid nanoparticle (LNP)-based vaccines such as BNT111 and mRNA-4157, emerging innate immune adjuvants including Toll-like receptor (TLR) and stimulator of interferon genes (STING) agonists, and rational combination strategies with immune checkpoint blockade. Key safety and quality consideration including immunotoxicity, off-target immune activation, and batch heterogeneity are critically evaluated alongside emerging engineering solutions. Finally, future directions integrating AI-guided neoantigen prediction, modular microfluidic manufacturing, and multi-omic biomarker frameworks are discussed to accelerate next generation cancer nanovaccine translation.
    Review • Journal • IO biomarker
    |
    STING (stimulator of interferon response cGAMP interactor 1)
    |
    BNT111 • intismeran autogene (mRNA-4157)
    29d
    BNT111-01: A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment (clinicaltrials.gov)
    P2, N=184, Completed, BioNTech SE | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Libtayo (cemiplimab-rwlc) • BNT111
    7ms
    Shared epitopes create safety and efficacy concerns in several cancer vaccines. (PubMed, J Immunother Cancer)
    Altogether, our analysis indicates a suboptimal design of several cancer vaccines currently in clinical development: ATP128, BNT111, BNT112, BNT116, INO-5401. We recommend that next-generation cancer vaccines should integrate rigorous epitope filtering strategies to eliminate shared sequences in TAAs.
    Journal
    |
    CLDN6 (Claudin 6) • KLK2 (Kallikrein-related peptidase 2) • ASCL2 (Achaete-Scute Family BHLH Transcription Factor 2)
    |
    BNT111 • INO-5401 • BNT116
    8ms
    BNT111-01: A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment (clinicaltrials.gov)
    P2, N=184, Active, not recruiting, BioNTech SE | Trial completion date: Jul 2026 --> Dec 2025
    Trial completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Libtayo (cemiplimab-rwlc) • BNT111
    over1year
    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
    over1year
    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
    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=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
    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: 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
    over2years
    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
    almost4years
    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
    4years
    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
    over4years
    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