Modality
ERT
MOA
CD47i
Target
FLT3
Pathway
Notch
HNSCC
Development Pipeline
Preclinical
~Feb 2015
→ ~May 2016
Phase 1
~Aug 2016
→ ~Nov 2017
Phase 2
~Feb 2018
→ ~May 2019
Phase 3
~Aug 2019
→ ~Nov 2020
NDA/BLA
Feb 2021
→ Jul 2029
NDA/BLACurrent
NCT07205484
1,296 pts·HNSCC
2021-08→2028-05·Recruiting
NCT03638613
1,845 pts·HNSCC
2021-02→2029-07·Recruiting
3,141 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-05-022.1y awayPh3 Readout· HNSCC
2029-07-173.3y awayPh3 Readout· HNSCC
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
NDA/BLA
Recruit…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2028-05-02 · 2.1y away
HNSCC
Ph3 Readout
2029-07-17 · 3.3y away
HNSCC
Recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07205484 | NDA/BLA | HNSCC | Recruiting | 1296 | PFS |
| NCT03638613 | NDA/BLA | HNSCC | Recruiting | 1845 | NT-proBNP |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8168 | Johnson & Johnson | Phase 2/3 | FLT3 | |
| Nirarelsin | Johnson & Johnson | Phase 2 | PRMT5 | |
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| NVS-1475 | Novartis | Phase 2 | Menin | |
| AZN-6294 | AstraZeneca | Phase 2/3 | APOC3 | |
| Zenonesiran | GSK | Preclinical | DLL3 | |
| AMG-7379 | Amgen | Preclinical | DLL3 | |
| Sotorapivir | Moderna | Approved | FLT3 | |
| BGN-3859 | BeiGene | Approved | PSMA |