← Pipeline|CSL-4459

CSL-4459

NDA/BLA
Source: Trial-derived·Trials: 1
Modality
Nanobody
MOA
HPK1i
Target
KRASG12D
Pathway
Wnt
MSGBM
Development Pipeline
Preclinical
~Mar 2016
~Jun 2017
Phase 1
~Sep 2017
~Dec 2018
Phase 2
~Mar 2019
~Jun 2020
Phase 3
~Sep 2020
~Dec 2021
NDA/BLA
Mar 2022
NDA/BLACurrent
NCT05019951
1,917 pts·MS
2022-03TBD·Completed
1,917 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-07-139mo agoEMA Filing· GBM
Trial Timeline
Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3
NDA/BLA
Complet…
Catalysts
EMA Filing
2025-07-13 · 9mo ago
GBM
Completed|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT05019951NDA/BLAMSCompleted1917EDSS
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-1944PfizerNDA/BLAAPOC3HPK1i
NVS-6974NovartisPreclinicalCD19HPK1i
RilulemzoparlimabNovartisPhase 2/3KRASG12DPD-L1i
ABB-7516AbbViePhase 3PD-L1HPK1i
BMY-2495Bristol-Myers SquibbPhase 3KRASG12DALKi
SNY-2934SanofiPhase 3KRASG12DUSP1i
TalainavolisibNovo NordiskPreclinicalKRASG12DPRMT5i
GIL-2037Gilead SciencesApprovedKRASG12DMDM2i
BemanesiranBioNTechPhase 3PLK4HPK1i
BII-5240BiogenPhase 2/3MALT1HPK1i