Modality
Gene Editing
MOA
IL-13i
Target
TNFα
Pathway
PD-1/PD-L1
FTDUrothelial Ca
Development Pipeline
Preclinical
~Nov 2016
→ ~Feb 2018
Phase 1
~May 2018
→ ~Aug 2019
Phase 2
~Nov 2019
→ ~Feb 2021
Phase 3
May 2021
→ May 2030
Phase 3Current
NCT08877035
2,110 pts·Urothelial Ca
2021-05→2025-07·Completed
NCT03953313
2,156 pts·FTD
2024-07→2030-05·Terminated
NCT03308702
945 pts·Urothelial Ca
2025-06→2029-01·Not yet recruiting
+1 more trial
5,824 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2025-07-079mo agoPh3 Readout· Urothelial Ca
2029-01-192.8y awayPh3 Readout· Urothelial Ca
2030-03-023.9y awayPh3 Readout· Urothelial Ca
2030-05-044.1y awayPh3 Readout· FTD
Trial Timeline
Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
P3
Complet…
P3
Termina…
P3
Termina…
P3
Not yet…
Catalysts
Ph3 Readout
2025-07-07 · 9mo ago
Urothelial Ca
Ph3 Readout
2029-01-19 · 2.8y away
Urothelial Ca
Ph3 Readout
2030-03-02 · 3.9y away
Urothelial Ca
Ph3 Readout
2030-05-04 · 4.1y away
FTD
CompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08877035 | Phase 3 | Urothelial Ca | Completed | 2110 | Biomarker |
| NCT03953313 | Phase 3 | FTD | Terminated | 2156 | CfB |
| NCT03308702 | Phase 3 | Urothelial Ca | Not yet recr... | 945 | SeizFreq |
| NCT06035740 | Phase 3 | Urothelial Ca | Terminated | 613 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| RHH-7975 | Roche | Phase 3 | FXIa | |
| NVS-8902 | Novartis | Preclinical | TROP-2 | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| GIL-6239 | Gilead Sciences | Phase 2 | TNFα | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| MRN-8225 | Moderna | Preclinical | TNFα |