Modality
Multispecific
MOA
DLL3 ADC
Target
PI3Kα
Pathway
Fibrosis
Ewing Sarcoma
Development Pipeline
Preclinical
~May 2022
→ ~Aug 2023
Phase 1
Nov 2023
→ May 2030
Phase 1Current
NCT06114587
357 pts·Ewing Sarcoma
2023-11→2030-05·Recruiting
357 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-07-143mo awayPDUFA· Ewing Sarcoma
2030-05-274.2y awayInterim· Ewing Sarcoma
Trial Timeline
Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
P1
Recruit…
Catalysts
PDUFA
2026-07-14 · 3mo away
Ewing Sarcoma
Interim
2030-05-27 · 4.2y away
Ewing Sarcoma
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06114587 | Phase 1 | Ewing Sarcoma | Recruiting | 357 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| NVS-4076 | Novartis | Preclinical | TROP-2 | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| AMG-9654 | Amgen | Phase 2 | GPRC5D | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα | |
| Sematenlimab | Samsung Biologics | Phase 3 | PI3Kα | |
| ROI-1081 | Roivant Sciences | Phase 1/2 | PI3Kα | |
| Terarasimod | Krystal Biotech | Phase 1/2 | PI3Kα |