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DRUG:

Fusion-VAC-XS15

i
Other names: Fusion-VAC-XS15, DNAJB1-PRKACA fusion transcript-based peptide vaccine
Associations
Company:
University Hospital Tuebingen
Drug class:
Immunostimulant, TLR1 agonist, TLR2 agonist
Related drugs:
Associations
7ms
FusionVAC22_01: a phase I clinical trial evaluating a DNAJB1-PRKACA fusion transcript-based peptide vaccine combined with immune checkpoint inhibition for fibrolamellar hepatocellular carcinoma and other tumor entities carrying the oncogenic driver fusion. (PubMed, Front Oncol)
Two doses of the DNAJB1-PRKACA fusion-based neoepitope vaccine Fusion-VAC-XS15 will be applied subcutaneously (s.c.) with a 4-week interval in combination with the anti-programmed cell death-ligand 1 (PD-L1) antibody atezolizumab starting at day 15 after the first vaccination. Clinical trial results will be published in peer-reviewed journals. EU CT Number: 2022-502869-17-01 and ClinicalTrials.gov Registry (NCT05937295).
P1 data • Journal • Checkpoint inhibition
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DNAJB1 (DnaJ Heat Shock Protein Family (Hsp40) Member B1) • PRKACA (Protein Kinase CAMP-Activated Catalytic Subunit Alpha)
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DNAJB1-PRKACA fusion
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Tecentriq (atezolizumab) • DNAJB1-PRKACA peptide vaccine • Fusion-VAC-XS15
11ms
FusionVAC22_01: A phase I clinical trial evaluating a DNAJB1-PRKACA fusion transcript-based peptide vaccine combined with immune checkpoint inhibition for fibrolamellar hepatocellular carcinoma and other tumor entities carrying the oncogenic driver fusion. (ASCO-GI 2024)
Based on these encouraging results, we established a Phase I open-label, multicentric clinical trial to evaluate the immunogenicity along with safety and toxicity, as well as first signs of efficacy of the FusionVAC-22 based peptide vaccine, combined with the immune checkpoint inhibitor (ICI) atezolizumab, in 20 patients with locally advanced or metastatic FL-HCC or other malignant diseases that carry the DNAJB1-PRKACA fusion transcript. Furthermore, disease control rate, quality of life as well as overall and progression free survival will be assessed. Clinical trial information: NCT05937295.
Clinical • P1 data • Checkpoint inhibition
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DNAJB1 (DnaJ Heat Shock Protein Family (Hsp40) Member B1) • PRKACA (Protein Kinase CAMP-Activated Catalytic Subunit Alpha)
|
DNAJB1-PRKACA fusion
|
Tecentriq (atezolizumab) • DNAJB1-PRKACA peptide vaccine • Fusion-VAC-XS15
1year
FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined With Immune Checkpoint Inhibition (clinicaltrials.gov)
P1, N=20, Recruiting, University Hospital Tuebingen | Not yet recruiting --> Recruiting
Enrollment open • Checkpoint inhibition
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DNAJB1 (DnaJ Heat Shock Protein Family (Hsp40) Member B1) • PRKACA (Protein Kinase CAMP-Activated Catalytic Subunit Alpha)
|
DNAJB1-PRKACA fusion
|
Tecentriq (atezolizumab) • DNAJB1-PRKACA peptide vaccine • Fusion-VAC-XS15
1year
FusionVAC22_01: A phase I clinical trial evaluating a DNAJB1-PRKACA fusion transcript-based peptide vaccine combined with immune checkpoint inhibition for fibrolamellar hepatocellular carcinoma and other tumor entities carrying the oncogenic driver fusion (DGHO 2023)
Most importantly, until now the second patient showed stable disease for 8 months after vaccination. Based on these promising data, we established a Phase I open label, multicentric clinical trial (EU-CT Number 2022-502869-17-00) evaluating the immunogenicity along with safety and toxicity, as well as first signs of efficacy of the FusionVAC-22 based peptide vaccine, combined with an ICI (anti-PD-L1), in 20 patients with locally advanced or metastatic FL-HCC or other malignant disease with proven presence of the DNAJB1-PRKACA fusion transcript.
Clinical • P1 data • Checkpoint inhibition
|
DNAJB1 (DnaJ Heat Shock Protein Family (Hsp40) Member B1) • PRKACA (Protein Kinase CAMP-Activated Catalytic Subunit Alpha)
|
DNAJB1-PRKACA fusion
|
DNAJB1-PRKACA peptide vaccine • Fusion-VAC-XS15
over1year
New P1 trial • Checkpoint inhibition
|
DNAJB1 (DnaJ Heat Shock Protein Family (Hsp40) Member B1) • PRKACA (Protein Kinase CAMP-Activated Catalytic Subunit Alpha)
|
DNAJB1-PRKACA fusion
|
Tecentriq (atezolizumab) • DNAJB1-PRKACA peptide vaccine • Fusion-VAC-XS15