Modality
Cell Therapy
MOA
USP1i
Target
CDK2
Pathway
Complement
MigraineMM
Development Pipeline
Preclinical
~Mar 2019
→ ~Jun 2020
Phase 1
~Sep 2020
→ ~Dec 2021
Phase 2
Mar 2022
→ Jan 2031
Phase 2Current
NCT08376933
1,827 pts·MM
2025-05→2031-01·Active
NCT04603208
2,932 pts·MM
2022-03→TBD·Completed
4,759 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-12-163mo agoAdCom· MM
2031-01-224.8y awayPh3 Readout· MM
Trial Timeline
2022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031
P2/3
Complet…
P2/3
Active
Catalysts
AdCom
2025-12-16 · 3mo ago
MM
Ph3 Readout
2031-01-22 · 4.8y away
MM
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08376933 | Phase 2/3 | MM | Active | 1827 | UPCR |
| NCT04603208 | Phase 2/3 | MM | Completed | 2932 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| Datozumab | Regeneron | Phase 1 | B7-H3 | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 | |
| BII-8315 | Biogen | NDA/BLA | CDK2 |