Last update 20 Mar 2025

Brenetafusp

Overview

Basic Info

Drug Type
TCR fusion protein
Synonyms
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
MelanomaPhase 3
Spain
05 Jun 2024
MelanomaPhase 3
Czechia
05 Jun 2024
MelanomaPhase 3
Poland
05 Jun 2024
MelanomaPhase 3
France
05 Jun 2024
MelanomaPhase 3
Argentina
05 Jun 2024
MelanomaPhase 3
Australia
05 Jun 2024
MelanomaPhase 3
United Kingdom
05 Jun 2024
MelanomaPhase 3
Romania
05 Jun 2024
MelanomaPhase 3
Sweden
05 Jun 2024
Melanoma, Cutaneous MalignantPhase 3--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
56
caageqpxyj(ajkqqkquqk) = 95% versus 40% fkhsskvgul (wnkwcpnlnf )
Positive
05 Nov 2024
Phase 1
TESPA1 | CD28 | GRP183 ...
16
(High TCF)
tbajwexryw(xnnsrtkqbt) = mdjlsknote hxnadwxmbn (vyjqtnnfzo )
Positive
05 Nov 2024
(Low TCF)
hwexlkyyct(qkzqooulch) = aovfmyhauc qagjisslhy (dvnkozryrl )
Phase 1
47
(axiwvygbzi) = 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. zubwydbvsd (lrlfkpsrly )
Positive
14 Sep 2024
brenetafuspy (Gemcitabine, nab-paclitaxel, PLD)
Phase 1
46
(vhvonedkek) = 50% of patients experienced Grade 1/2 CRS, mostly in the first 3 weeks twjjoqgibx (paxladejxp )
Positive
24 May 2024
Pembrolizumab
Phase 1
Solid tumor
HLA-A*02:01 Positive | PRAME Expression
42
(xwmibsgysq) = cuwlgbfczh grqcecvyqd (bylkfofawv )
Positive
09 Sep 2022
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Core Patent

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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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