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    DRUG:

    autogene cevumeran (RG6180)

    i
    Other names: RG6180, RO-7198457, RO 7198457, RO7198457, PCV RO7198457, RG6180-1, BNT122, iNeST, RG-6180, RG 6180, BNT-122, BNT 122
    Company:
    BioNTech, Roche
    Drug class:
    Immunostimulant
    Related drugs:
    13d
    Reprogramming Immunosuppressive Niches and the Cancer Immunity Cycle in Pancreatic Cancer with Neoantigen mRNA Plus Immune Adjuvant Nanocarrier Strategies. (PubMed, ACS Nano)
    Clinically, the autogene cevumeran (BNT122) mRNA-lipoplex vaccine demonstrated that individualized neoantigen delivery can elicit durable, tissue-resident CD8+ T cells and prolong recurrence-free survival in resected PDAC, marking a breakthrough in restoring adaptive immunity to an otherwise "cold" tumor...Complementary silicasome platforms (lipid bilayer coated mesoporous silica nanoparticles) encapsulating irinotecan to induce immunogenic cell death (ICD) synergize with spleen-targeting LNPs carrying KRAS mRNA and TLR7/8 agonists, thereby bridging local antigen release with systemic T-cell priming. Together, these studies establish a translational framework wherein nanoparticle-based immunotherapy can both enhance and extend the benefits of mRNA vaccines from localized to metastatic PDAC. By integrating ICD induction, neoantigen targeting, and immune niche reprogramming, these modular nanomedicine platforms offer a realistic path toward scalable, durable, and systemically effective PDAC immunotherapy.
    Review • Journal • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    irinotecan • autogene cevumeran (RG6180)
    2ms
    IMCODE003: A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC (clinicaltrials.gov)
    P2, N=260, Recruiting, Genentech, Inc. | Trial completion date: Dec 2029 --> Jan 2031 | Trial primary completion date: Dec 2029 --> Jan 2031
    Trial completion date • Trial primary completion date
    |
    Tecentriq (atezolizumab) • oxaliplatin • irinotecan • autogene cevumeran (RG6180)
    3ms
    IMCODE-004: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC) (clinicaltrials.gov)
    P2, N=362, Recruiting, Hoffmann-La Roche | Suspended --> Recruiting
    Enrollment open • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • autogene cevumeran (RG6180)
    5ms
    IMCODE-004: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC) (clinicaltrials.gov)
    P2, N=362, Suspended, Hoffmann-La Roche | Recruiting --> Suspended
    Trial suspension • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • autogene cevumeran (RG6180)
    5ms
    GO39733: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors (clinicaltrials.gov)
    P1, N=272, Completed, Genentech, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    8ms
    GO39733: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors (clinicaltrials.gov)
    P1, N=272, Active, not recruiting, Genentech, Inc. | Trial completion date: Mar 2025 --> Jun 2025 | Trial primary completion date: Mar 2025 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    9ms
    IMCODE-004: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC) (clinicaltrials.gov)
    P2, N=362, Recruiting, Hoffmann-La Roche | Initiation date: Jul 2024 --> Dec 2024
    Trial initiation date
    |
    Opdivo (nivolumab) • autogene cevumeran (RG6180)
    10ms
    RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer. (PubMed, Nature)
    At an extended 3.2-year median follow-up from a phase 1 trial of surgery, atezolizumab (PD-L1 inhibitory antibody), autogene cevumeran1 (individualized neoantigen vaccine with backbone-optimized uridine mRNA-lipoplex nanoparticles) and modified (m) FOLFIRINOX (chemotherapy) in patients with PDAC, we find that responders with vaccine-induced T cells (n = 8) have prolonged recurrence-free survival (RFS; median not reached) compared with non-responders without vaccine-induced T cells (n = 8; median RFS 13.4 months; P  =  0.007)...Thus, in PDAC, autogene cevumeran induces de novo CD8+ T cells with multiyear longevity, substantial magnitude and durable effector functions that may delay PDAC recurrence. Adjuvant mRNA-lipoplex neoantigen vaccines may thus solve a pivotal obstacle for cancer vaccination.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    Tecentriq (atezolizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • autogene cevumeran (RG6180)
    10ms
    IMCODE001: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma. (clinicaltrials.gov)
    P2, N=131, Completed, Genentech, Inc. | Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Jan 2025 | Trial primary completion date: Oct 2025 --> Jan 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • autogene cevumeran (RG6180)
    11ms
    Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial. (PubMed, Nat Med)
    These findings support the continued development of autogene cevumeran in earlier treatment lines. ClinicalTrials.gov registration: NCT03289962 .
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    12ms
    Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery (clinicaltrials.gov)
    P1, N=29, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Surgery
    |
    Tecentriq (atezolizumab) • irinotecan • autogene cevumeran (RG6180)
    1year
    BNT122-01: A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer (clinicaltrials.gov)
    P2, N=327, Recruiting, BioNTech SE | N=229 --> 327 | Trial completion date: Jul 2027 --> Aug 2030 | Trial primary completion date: Feb 2026 --> Nov 2026
    Enrollment change • Trial completion date • Trial primary completion date • Circulating tumor DNA
    |
    autogene cevumeran (RG6180)