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    DRUG CLASS:

    MAGE-A3 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
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    STING (stimulator of interferon response cGAMP interactor 1)
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    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
    4ms
    Innovative therapeutic cancer vaccine PDC∗lung01 with or without anti-PD-1: an open-label, dose-escalation phase I/II study in non-small-cell lung cancer. (PubMed, ESMO Open)
    PDC∗lung01 was immunogenic and had a manageable safety profile in all cohorts and met the predefined clinical objectives when combined with anti-PD-1 in metastatic NSCLC. Median PFS was positively correlated with antigen-specific T-cell expansions.
    P1/2 data • Journal
    |
    PD-L1 (Programmed death ligand 1) • MUC1 (Mucin 1) • BIRC5 (Baculoviral IAP repeat containing 5) • CTAG1B (Cancer/testis antigen 1B) • MAGEA4 (Melanoma antigen family A, 4)
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    PDC*lung
    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
    PDC-LUNG-101: Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (clinicaltrials.gov)
    P1/2, N=73, Active, not recruiting, PDC*line Pharma SAS | Trial primary completion date: Dec 2025 --> Jul 2024
    Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A)
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    HLA-A*02
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    Keytruda (pembrolizumab) • pemetrexed • PDC*lung
    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
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    CTAG1B (Cancer/testis antigen 1B)
    |
    BNT111
    over2years
    PDC-LUNG-101: Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (clinicaltrials.gov)
    P1/2, N=73, Active, not recruiting, PDC*line Pharma SAS | Recruiting --> Active, not recruiting | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2025 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    HLA-A*02
    |
    Keytruda (pembrolizumab) • pemetrexed • PDC*lung
    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
    PDC-LUNG-101: Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (clinicaltrials.gov)
    P1/2, N=64, Recruiting, PDC*line Pharma SAS | Trial completion date: Aug 2024 --> Sep 2025 | Trial primary completion date: Aug 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    HLA-A*02
    |
    Keytruda (pembrolizumab) • pemetrexed • PDC*lung
    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