Modality
Nanobody
MOA
PCSK9i
Target
FXIa
Pathway
JAK/STAT
HNSCC
Development Pipeline
Preclinical
~May 2015
→ ~Aug 2016
Phase 1
~Nov 2016
→ ~Feb 2018
Phase 2
May 2018
→ Sep 2029
Phase 2Current
NCT04223478
1,450 pts·HNSCC
2025-01→2029-09·Active
NCT04366483
409 pts·HNSCC
2018-05→TBD·Recruiting
1,859 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2029-09-273.5y awayPh3 Readout· HNSCC
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
P2/3
Recruit…
P2/3
Active
Catalysts
Ph3 Readout
2029-09-27 · 3.5y away
HNSCC
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04223478 | Phase 2/3 | HNSCC | Active | 1450 | ACR20 |
| NCT04366483 | Phase 2/3 | HNSCC | Recruiting | 409 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-1085 | Pfizer | Preclinical | FXIa | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| RHH-7975 | Roche | Phase 3 | FXIa | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| Rimaosocimab | Amgen | Preclinical | FXIa |