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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:
16d
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)
3ms
Enrollment open
|
Opdivo (nivolumab) • autogene cevumeran (RG6180)
7ms
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."
P2 data • Clinical
|
CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • CCR7 (Chemokine (C-C motif) receptor 7)
|
autogene cevumeran (RG6180)
7ms
Trial completion date • Trial primary completion date
|
Tecentriq (atezolizumab) • oxaliplatin • irinotecan • autogene cevumeran (RG6180)
9ms
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
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)
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: 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
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)
4years
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
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)