← Pipeline|FRE-IIT-769

FRE-IIT-769

Phase 2/3
Source: Trial-derived·Trials: 1
Modality
Gene Therapy
MOA
CFTRmod
Target
PLK4
Pathway
PD-1/PD-L1
AML
Development Pipeline
Preclinical
~Oct 2017
~Jan 2019
Phase 1
~Apr 2019
~Jul 2020
Phase 2
Oct 2020
Dec 2028
Phase 2Current
NCT03556730
998 pts·AML
2020-102028-12·Terminated
998 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-12-072.7y awayPh3 Readout· AML
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
P2/3
Termina…
Catalysts
Ph3 Readout
2028-12-07 · 2.7y away
AML
Terminated|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT03556730Phase 2/3AMLTerminated998EFS
Competitors (10)
DrugCompanyPhaseTargetMOA
LLY-4358Eli LillyPhase 3B7-H3CFTRmod
GelinaritideAbbViePreclinicalFcRnCFTRmod
BemanesiranBioNTechPhase 3PLK4HPK1i
DarafutibatinibBioNTechPreclinicalPRMT5CFTRmod
ALN-8757AlnylamPreclinicalTIGITCFTRmod
PeminaritideSareptaNDA/BLAPLK4JAK1/2i
PexaosocimabUnited TherapeuticsNDA/BLAPLK4KRASG12Ci
PolalucimabJazz PharmaPreclinicalPLK4EZH2i
ILM-2412IlluminaPhase 3PLK4AuroraAi
ROI-3353Roivant SciencesPhase 1/2PLK4IL-13i