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← Pipeline|MSK-IIT-346

MSK-IIT-346

Phase 2
By MSKCC Breast Svc
Source: Trial-derived·Trials: 1
Modality
Gene Therapy
MOA
RAS(ON)i
Target
ALK
Pathway
STING
PAH
Development Pipeline
Preclinical
~Sep 2021
→ ~Dec 2022
Phase 1
~Mar 2023
→ ~Jun 2024
Phase 2
Sep 2024
→ Aug 2027
Phase 2Current
NCT07333308
650 pts·PAH
2024-09→2027-08·Completed
650 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-12-044mo agoAdCom· PAH
2027-08-211.4y awayPh2 Data· PAH
Trial Timeline
Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3
P2
Complet…
Catalysts
AdCom
2025-12-04 · 4mo ago
PAH
Ph2 Data
2027-08-21 · 1.4y away
PAH
Completed|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT07333308Phase 2PAHCompleted650BodyWt
Competitors (10)
DrugCompanyPhaseTargetMOA
MRK-8368Merck & CoPhase 3ALKPCSK9i
MRK-6781Merck & CoApprovedTIGITRAS(ON)i
SNY-9073SanofiPhase 2B7-H3RAS(ON)i
GSK-6983GSKPhase 2ALKIL-23i
BAY-3308BayerPhase 1ALKSGLT2i
TixarelsinVertex PharmaPhase 1ALKRAS(ON)i
VRT-6833Vertex PharmaPreclinicalALKVEGFi
FixatuximabLegend BiotechPreclinicalCFTRRAS(ON)i
NiralucimabIonisPhase 1ALKKRASG12Ci
ION-1378IonisNDA/BLATROP-2RAS(ON)i