Modality
Fusion Protein
MOA
STINGag
Target
BTK
Pathway
STING
MelanomaHNSCC
Development Pipeline
Preclinical
~Nov 2010
→ ~Feb 2012
Phase 1
~May 2012
→ ~Aug 2013
Phase 2
~Nov 2013
→ ~Feb 2015
Phase 3
~May 2015
→ ~Aug 2016
NDA/BLA
~Nov 2016
→ ~Feb 2018
Approved
May 2018
→ May 2026
ApprovedCurrent
NCT04933213
783 pts·Melanoma
2018-05→2026-05·Completed
783 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2026-05-021mo awayPh3 Readout· Melanoma
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2
Approved
Complet…
Catalysts
Ph3 Readout
2026-05-02 · 1mo away
Melanoma
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04933213 | Approved | Melanoma | Completed | 783 | CR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| RHH-5389 | Roche | Preclinical | RET | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| SNY-5894 | Sanofi | Approved | CFTR | |
| SNY-4496 | Sanofi | Phase 2/3 | CD3 | |
| SNY-5783 | Sanofi | Phase 1/2 | MET | |
| Zorizanubrutinib | Novo Nordisk | Phase 1 | BTK | |
| DSN-1421 | Daiichi Sankyo | Phase 3 | Nectin-4 | |
| GIL-4361 | Gilead Sciences | Preclinical | PCSK9 | |
| INC-5849 | Incyte | Phase 2 | PCSK9 |