Modality
Gene Editing
MOA
BCL-2i
Target
MALT1
Pathway
STING
WilmsSCLC
Development Pipeline
Preclinical
~Jan 2021
→ ~Apr 2022
Phase 1
~Jul 2022
→ ~Oct 2023
Phase 2
Jan 2024
→ Jul 2025
Phase 2Current
NCT03656762
820 pts·SCLC
2024-01→TBD·Terminated
NCT05555520
663 pts·Wilms
2025-04→2025-07·Active
1,483 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-07-159mo agoPh3 Readout· Wilms
Trial Timeline
2024Q2Q3Q42025Q2Q3
P2/3
Termina…
P2/3
Active
Catalysts
Ph3 Readout
2025-07-15 · 9mo ago
Wilms
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03656762 | Phase 2/3 | SCLC | Terminated | 820 | EDSS |
| NCT05555520 | Phase 2/3 | Wilms | Active | 663 | HAM-D |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 | |
| ALN-3958 | Alnylam | Phase 2 | MALT1 |