Last update 04 Jun 2025

Brenetafusp

Overview

Basic Info

Drug Type
TCR fusion protein
Synonyms
IMC F106C, IMC-F106C, PRAME-A02
Action
stimulants, inhibitors
Mechanism
CD3 stimulants(T cell surface glycoprotein CD3 stimulants), PRAME inhibitors(PRAME nuclear receptor transcriptional regulator inhibitors), Immunologic cytotoxicity
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Unresectable MelanomaPhase 3
United States
05 Jun 2024
Unresectable MelanomaPhase 3
Argentina
05 Jun 2024
Unresectable MelanomaPhase 3
Australia
05 Jun 2024
Unresectable MelanomaPhase 3
Austria
05 Jun 2024
Unresectable MelanomaPhase 3
Belgium
05 Jun 2024
Unresectable MelanomaPhase 3
Brazil
05 Jun 2024
Unresectable MelanomaPhase 3
Bulgaria
05 Jun 2024
Unresectable MelanomaPhase 3
Canada
05 Jun 2024
Unresectable MelanomaPhase 3
Czechia
05 Jun 2024
Unresectable MelanomaPhase 3
Denmark
05 Jun 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
56
scptrgavnp(zyimwdzkiw) = 95% versus 40% iwizwyjfdn (pdtxjrngmt )
Positive
05 Nov 2024
Phase 1
TESPA1 | CD28 | GRP183 ...
16
(High TCF)
rhzhhvkaba(tnxryzdpez) = dmerisbvbv gtlfvxixed (bepxyjetrm )
Positive
05 Nov 2024
(Low TCF)
gtonhdbefl(faamzrujxy) = csmbxempim lzveaxrxax (bnyexdyhfj )
Phase 1
47
rdvlshavkd(dnrsczuind) = Most common adverse event (AE) was Grade 1/2 cytokine release syndrome (mono 53%, CC 80%). No drug-related AE led to treatment discontinuation or death. krfttgjzbc (epwytcppei )
Positive
14 Sep 2024
brenetafuspy (Gemcitabine, nab-paclitaxel, PLD)
Phase 1
Melanoma, Cutaneous Malignant
HLA-A*0201 Positive | PRAME Negative | Circulating Tumor-Derived DNA Positive | ...
46
wyqkdgdlzs(vghasiosyu) = 50% of patients experienced Grade 1/2 CRS, mostly in the first 3 weeks qxnasijlof (oyeoaiifpw )
Positive
24 May 2024
Phase 1
Solid tumor
HLA-A*02:01 Positive | PRAME Expression
42
wdbgfjbuqx(sdpwlkmqps) = dejvmtzxbg afuuzidtyy (pjaonhrkuw )
Positive
09 Sep 2022
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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