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BNT113
i
Other names: BNT113, HPV FixVAC, Hare-40 FixVAC, RBLO 15.1(LIP)/RBLO 16.1(LIP), E6/E7 RNA(LIP), HPV mRNA vaccine, HPV anti-CD40 RNA vaccine, BNT 113, BNT-113
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News alerts, weekly reports and conference planners
Company:
BioNTech
Drug class:
HPV-16 E6 protein inhibitor, HPV-16 E7 protein inhibitor
Related drugs:
6d
A novel mRNA-based therapeutic vaccine elicits robust anti-tumor immunity against HPV-associated malignancies. (PubMed, Front Immunol)
In this study, we developed TriStim-E6/E7, a novel HPV mRNA vaccine that combines E6/E7 antigens with three T cell co-stimulatory molecules (CD80, 4-1BBL, and CD70)...Additionally, a "cytokine release storm" experiment using PBMC-reconstituted mice confirmed a favorable safety profile of TriStim-E6/E7 mRNA. These findings collectively demonstrate the promising therapeutic potential of TriStim-E6/E7 mRNA for clinical translation against HPV-associated malignancies.
Journal
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CD8 (cluster of differentiation 8) • CD70 (CD70 Molecule) • CD4 (CD4 Molecule) • CD27 (CD27 Molecule) • CD80 (CD80 Molecule)
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BNT113
1year
AHEAD-MERIT: A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 (clinicaltrials.gov)
P2/3, N=350, Recruiting, BioNTech SE | Phase classification: P2 --> P2/3 | Trial completion date: May 2028 --> Apr 2029 | Trial primary completion date: May 2028 --> Apr 2029
Phase classification • Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1)
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Keytruda (pembrolizumab) • BNT113
over1year
Observational study on the correlation between the immune response of patients' peripheral blood stimulated by therapeutic HPV mRNA vaccine in vitro and the pathological results and clinical prognosis of patients (ChiCTR2400087487)
P=N/A, N=150, Not yet recruiting, Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine; Renji Hospital affiliated to Shanghai Jiaotong University School of Medi
New trial
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BNT113
over2years
HARE-40: HPV Anti-CD40 RNA vaccinE (clinicaltrials.gov)
P1/2, N=32, Completed, University of Southampton | Active, not recruiting --> Completed
Trial completion
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BNT113
over2years
AHEAD-MERIT: A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 (clinicaltrials.gov)
P2, N=285, Recruiting, BioNTech SE
Trial completion date • Trial primary completion date • Combination therapy • Metastases
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PD-L1 (Programmed death ligand 1)
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Keytruda (pembrolizumab) • BNT113
over3years
AHEAD-MERIT: A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 (clinicaltrials.gov)
P2; Trial completion date: May 2025 --> May 2028 | Trial primary completion date: May 2025 --> May 2028
Combination therapy • Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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PD-L1 IHC 22C3 pharmDx
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Keytruda (pembrolizumab) • BNT113
5years
AHEAD-MERIT: A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 (clinicaltrials.gov)
P2, N=285, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
Clinical • Enrollment open • Combination therapy
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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Keytruda (pembrolizumab) • BNT113
over5years
AHEAD-MERIT: A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 (clinicaltrials.gov)
P2, N=285, Not yet recruiting, BioNTech SE
Clinical • New P2 trial • Combination therapy
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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Keytruda (pembrolizumab) • BNT113
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