Modality
Gene Editing
MOA
CDK4/6i
Target
MET
Pathway
Complement
Ewing Sarcoma
Development Pipeline
Preclinical
~May 2014
→ ~Aug 2015
Phase 1
~Nov 2015
→ ~Feb 2017
Phase 2
~May 2017
→ ~Aug 2018
Phase 3
~Nov 2018
→ ~Feb 2020
NDA/BLA
May 2020
→ Feb 2027
NDA/BLACurrent
NCT05602656
1,085 pts·Ewing Sarcoma
2023-07→2027-02·Active
NCT08935657
1,031 pts·Ewing Sarcoma
2020-05→2026-06·Terminated
2,116 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-06-213mo awayPh3 Readout· Ewing Sarcoma
2027-02-2311mo awayPh3 Readout· Ewing Sarcoma
Trial Timeline
Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
NDA/BLA
Termina…
NDA/BLA
Active
Catalysts
Ph3 Readout
2026-06-21 · 3mo away
Ewing Sarcoma
Ph3 Readout
2027-02-23 · 11mo away
Ewing Sarcoma
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05602656 | NDA/BLA | Ewing Sarcoma | Active | 1085 | CR |
| NCT08935657 | NDA/BLA | Ewing Sarcoma | Terminated | 1031 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| RHH-1969 | Roche | Approved | BET | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| SNY-5783 | Sanofi | Phase 1/2 | MET | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| Sotosacituzumab | Vertex Pharma | Phase 1 | MET | |
| VRT-5441 | Vertex Pharma | Phase 3 | GLP-1R | |
| Adagracapivasertib | BeiGene | NDA/BLA | BET |