Modality
Vaccine
MOA
KRASG12Ci
Target
CDK2
Pathway
PD-1/PD-L1
ThymomaFSGS
Development Pipeline
Preclinical
~May 2015
→ ~Aug 2016
Phase 1
~Nov 2016
→ ~Feb 2018
Phase 2
May 2018
→ Dec 2028
Phase 2Current
NCT07574397
2,801 pts·FSGS
2018-05→TBD·Active
NCT03278862
1,208 pts·Thymoma
2020-03→2028-12·Completed
4,009 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-12-032.7y awayPh3 Readout· Thymoma
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
P2/3
Active
P2/3
Complet…
Catalysts
Ph3 Readout
2028-12-03 · 2.7y away
Thymoma
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07574397 | Phase 2/3 | FSGS | Active | 2801 | Safety |
| NCT03278862 | Phase 2/3 | Thymoma | Completed | 1208 | PFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| Lisolucimab | Novartis | Approved | CD20 | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 |