Modality
Cell Therapy
MOA
WRNi
Target
MALT1
Pathway
Fibrosis
Prostate CaMesoMigraine
Development Pipeline
Preclinical
~Nov 2014
→ ~Feb 2016
Phase 1
~May 2016
→ ~Aug 2017
Phase 2
~Nov 2017
→ ~Feb 2019
Phase 3
~May 2019
→ ~Aug 2020
NDA/BLA
Nov 2020
→ Dec 2027
NDA/BLACurrent
NCT08113716
2,918 pts·Meso
2024-11→2027-12·Recruiting
NCT07111591
1,580 pts·Prostate Ca
2020-11→2025-03·Terminated
4,498 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-03-241.0y agoPh3 Readout· Prostate Ca
2025-10-275mo agoEnrollment Complete· Meso
2027-12-101.7y awayPh3 Readout· Meso
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
NDA/BLA
Termina…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2025-03-24 · 1.0y ago
Prostate Ca
Enrollment Complete
2025-10-27 · 5mo ago
Meso
Ph3 Readout
2027-12-10 · 1.7y away
Meso
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08113716 | NDA/BLA | Meso | Recruiting | 2918 | FEV1 |
| NCT07111591 | NDA/BLA | Prostate Ca | Terminated | 1580 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| GSK-4334 | GSK | Preclinical | CD47 | |
| AMG-2752 | Amgen | Preclinical | MDM2 | |
| REG-7737 | Regeneron | Preclinical | CD123 | |
| VRT-5853 | Vertex Pharma | Phase 3 | Aβ | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 | |
| ALN-3958 | Alnylam | Phase 2 | MALT1 |