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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:
    2d
    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)
    19d
    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)
    2ms
    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: Nov 2024 --> Mar 2025 | Trial primary completion date: Nov 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    5ms
    IMCODE004: 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 | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • autogene cevumeran (RG6180)
    5ms
    IMCODE004: 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, Not yet recruiting, Hoffmann-La Roche
    New P2 trial
    |
    Opdivo (nivolumab) • autogene cevumeran (RG6180)
    8ms
    Characterization of T cell responses induced by the individualized mRNA neoantigen vaccine autogene cevumeran in adjuvant stage II (high risk)/stage III colorectal cancer (CRC) patients (pts) from the biomarker cohort of the phase II BNT122-01 trial (ESMO-GI 2024)
    P2 | "In adjuvant CRC pts, autogene cevumeran induces poly-epitopic neoantigen-specific T-cell responses of high magnitude in all pts treated. Long-term immune response data will be presented."
    Clinical • P2 data
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • CCR7 (Chemokine (C-C motif) receptor 7)
    |
    autogene cevumeran (RG6180)
    8ms
    IMCODE003: A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P2, N=260, Recruiting, Genentech, Inc. | Trial completion date: May 2029 --> Dec 2029 | Trial primary completion date: May 2029 --> Dec 2029
    Trial completion date • Trial primary completion date
    |
    Tecentriq (atezolizumab) • oxaliplatin • irinotecan • autogene cevumeran (RG6180)
    8ms
    Characterization of T cell responses induced by the individualized mRNA neoantigen vaccine autogene cevumeran in adjuvant stage II (high risk)/stage III colorectal cancer patients from the biomarker cohort of the phase 2 BNT122-01 trial. (ASCO 2024)
    P2 | "Clinical Trial Registration Number: NCT04486378"
    Clinical • P2 data
    |
    autogene cevumeran (RG6180)
    10ms
    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. | Phase classification: P1a/1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    1year
    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, Active, not recruiting, Genentech, Inc. | Trial completion date: Jun 2024 --> Oct 2025 | Trial primary completion date: Jun 2024 --> Oct 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • autogene cevumeran (RG6180)
    1year
    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=201, Recruiting, BioNTech SE | Trial primary completion date: Sep 2023 --> Feb 2026
    Trial primary completion date • Circulating tumor DNA
    |
    autogene cevumeran (RG6180)
    over1year
    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)
    P1a/1b, N=272, Active, not recruiting, Genentech, Inc. | Trial completion date: Sep 2023 --> Nov 2024 | Trial primary completion date: Sep 2023 --> Nov 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    over1year
    Personalized mRNA Vaccine Immunogenic against PDAC. (PubMed, Cancer Discov)
    BioNTech's personalized mRNA vaccine, autogene cevumeran, elicited neoantigen-specific T cells in eight of 16 patients with surgically resected pancreatic ductal adenocarcinoma, leading to T-cell expansion in the bloodstream and delays in disease recurrence, according to phase I trial data. A randomized follow-up study is planned.
    Journal
    |
    autogene cevumeran (RG6180)
    over1year
    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 2023 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Nov 2024
    Trial completion date • Trial primary completion date • Surgery
    |
    Tecentriq (atezolizumab) • irinotecan • autogene cevumeran (RG6180)
    over1year
    Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. (PubMed, Nature)
    After surgery, we sequentially administered atezolizumab (an anti-PD-L1 immunotherapy), autogene cevumeran (a maximum of 20 neoantigens per patient) and a modified version of a four-drug chemotherapy regimen (mFOLFIRINOX, comprising folinic acid, fluorouracil, irinotecan and oxaliplatin). Differences in the immune fitness of the patients did not confound this correlation, as responders and non-responders mounted equivalent immunity to a concurrent unrelated mRNA vaccine against SARS-CoV-2. Thus, adjuvant atezolizumab, autogene cevumeran and mFOLFIRINOX induces substantial T cell activity that may correlate with delayed PDAC recurrence.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    Tecentriq (atezolizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • autogene cevumeran (RG6180)
    almost2years
    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)
    P1a/1b, N=272, Active, not recruiting, Genentech, Inc. | Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Jun 2023 --> Sep 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    almost2years
    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)
    P1a/1b, N=272, Active, not recruiting, Genentech, Inc. | Trial completion date: Feb 2024 --> Jun 2023 | Trial primary completion date: Feb 2024 --> Jun 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    over2years
    A Fit-for-Purpose Method to Measure Circulating Levels of the mRNA Component of a Liposomal-Formulated Individualized Neoantigen-Specific Therapy for Cancer. (PubMed, AAPS J)
    Autogene cevumeran is an individualized neoantigen-specific therapy (iNeST) under development for the treatment of various solid tumors...A branched DNA (bDNA)-based mRNA PK assay was developed to achieve the desired assay performance. Here, we discuss the evaluation of various sample collection and processing conditions as well as the optimization of the work flow during bDNA PK method development.
    Journal
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    autogene cevumeran (RG6180)
    almost3years
    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)
    P1a/1b, N=272, Active, not recruiting, Genentech, Inc. | Recruiting --> Active, not recruiting | N=770 --> 272
    Enrollment closed • Enrollment change • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    over4years
    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)
    P1a/1b; Trial completion date: Oct 2020 --> Feb 2024 | Trial primary completion date: Sep 2020 --> Feb 2024
    Combination therapy • Trial completion date • Trial primary completion date • Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    over4years
    [VIRTUAL] A phase Ib study to evaluate RO7198457, an individualized Neoantigen Specific immunoTherapy (iNeST), in combination with atezolizumab in patients with locally advanced or metastatic solid tumors (AACR-II 2020)
    RO7198457 in combination with atezolizumab has a manageable safety profile consistent with the mechanisms of action of the study drugs and induces significant levels of neoantigen-specific immune responses. A randomized Ph2 study of RO7198457 1L melanoma patients in combination with pembrolizumab has been initiated, and two randomized clinical trials are planned for the adjuvant treatment of patients with NSCLC and CRC.
    Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    over5years
    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)
    P1a/1b; N=567 --> 770
    Combination therapy • Enrollment change • Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)