← Pipeline|GEN-5535

GEN-5535

Phase 1
Source: Trial-derived·Trials: 2
Modality
mRNA
MOA
ALKi
Target
APOC3
Pathway
Angiogenesis
AML
Development Pipeline
Preclinical
~Oct 2015
~Jan 2017
Phase 1
Apr 2017
Nov 2031
Phase 1Current
NCT03105978
2,903 pts·AML
2017-042031-10·Terminated
NCT05751024
2,921 pts·AML
2017-092031-11·Completed
5,824 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2031-10-215.6y awayInterim· AML
2031-11-015.6y awayInterim· AML
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P1
Termina…
P1
Complet…
Catalysts
Interim
2031-10-21 · 5.6y away
AML
Interim
2031-11-01 · 5.6y away
AML
CompletedTerminated|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT03105978Phase 1AMLTerminated2903PANSS
NCT05751024Phase 1AMLCompleted2921CR
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-1944PfizerNDA/BLAAPOC3HPK1i
MiriosocimabPfizerPhase 1PARPALKi
DoxacapivasertibEli LillyPhase 3APOC3MDM2i
MRK-7739Merck & CoPreclinicalIL-23ALKi
AZN-6294AstraZenecaPhase 2/3APOC3CD47i
BMY-2495Bristol-Myers SquibbPhase 3KRASG12DALKi
ZanutinibBristol-Myers SquibbPhase 2/3APOC3BiTE
DSN-5254Daiichi SankyoPhase 1B7-H3ALKi
SovacapivasertibAmgenPhase 3WEE1ALKi
ZanuratamabGilead SciencesPhase 1/2CDK2ALKi