Modality
Fusion Protein
MOA
KRASG12Ci
Target
IL-23
Pathway
Complement
HCCMeso
Development Pipeline
Preclinical
~Feb 2011
→ ~May 2012
Phase 1
~Aug 2012
→ ~Nov 2013
Phase 2
~Feb 2014
→ ~May 2015
Phase 3
~Aug 2015
→ ~Nov 2016
NDA/BLA
Feb 2017
→ Jan 2028
NDA/BLACurrent
NCT04354139
1,324 pts·HCC
2022-08→2028-01·Recruiting
NCT07138019
1,082 pts·HCC
2017-02→2026-03·Active
2,406 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-03-103w agoPh3 Readout· HCC
2028-01-241.8y awayPh3 Readout· HCC
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2
NDA/BLA
Active
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2026-03-10 · 3w ago
HCC
Ph3 Readout
2028-01-24 · 1.8y away
HCC
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04354139 | NDA/BLA | HCC | Recruiting | 1324 | UPCR |
| NCT07138019 | NDA/BLA | HCC | Active | 1082 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Lisolucimab | Novartis | Approved | CD20 | |
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| DSN-6862 | Daiichi Sankyo | Preclinical | IL-23 | |
| Tezecilimab | Regeneron | Approved | IL-23 | |
| ALN-6288 | Alnylam | Approved | LAG-3 | |
| BMR-9762 | BioMarin | Phase 3 | Aβ | |
| Niralucimab | Ionis | Phase 1 | ALK |