Modality
Gene Therapy
MOA
CFTRmod
Target
MET
Pathway
Wnt
NSCLCHNSCC
Development Pipeline
Preclinical
~Aug 2022
→ ~Nov 2023
Phase 1
~Feb 2024
→ ~May 2025
Phase 2
Aug 2025
→ Dec 2025
Phase 2Current
NCT03169131
1,418 pts·HNSCC
2025-08→2025-12·Recruiting
1,418 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-12-074mo agoPh3 Readout· HNSCC
2026-02-231mo agoConference· NSCLC
2026-10-217mo awayNDA· HNSCC
Trial Timeline
Q42026Q2Q3Q4
P2/3
Recruit…
Catalysts
Ph3 Readout
2025-12-07 · 4mo ago
HNSCC
Conference
2026-02-23 · 1mo ago
NSCLC
NDA
2026-10-21 · 7mo away
HNSCC
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03169131 | Phase 2/3 | HNSCC | Recruiting | 1418 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| SNY-5783 | Sanofi | Phase 1/2 | MET | |
| Sotosacituzumab | Vertex Pharma | Phase 1 | MET | |
| Darafutibatinib | BioNTech | Preclinical | PRMT5 | |
| ALN-8757 | Alnylam | Preclinical | TIGIT | |
| RVM-274 | Revolution Medicines | Phase 3 | MET | |
| Ivotuximab | Madrigal Pharma | Phase 2 | CD123 | |
| Talazasiran | Kymera | NDA/BLA | MET | |
| DAW-8159 | Day One Bio | Phase 2 | PSMA |