Modality
Gene Therapy
MOA
FXIai
Target
TIM-3
Pathway
Apoptosis
Cervical Ca
Development Pipeline
Preclinical
~Nov 2017
→ ~Feb 2019
Phase 1
May 2019
→ Feb 2031
Phase 1Current
NCT08653596
931 pts·Cervical Ca
2019-05→2031-02·Completed
NCT04481331
535 pts·Cervical Ca
2022-03→2030-08·Completed
1,466 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2030-08-144.4y awayInterim· Cervical Ca
2031-02-054.9y awayInterim· Cervical Ca
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P1
Complet…
P1
Complet…
Catalysts
Interim
2030-08-14 · 4.4y away
Cervical Ca
Interim
2031-02-05 · 4.9y away
Cervical Ca
Completed|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08653596 | Phase 1 | Cervical Ca | Completed | 931 | ORR |
| NCT04481331 | Phase 1 | Cervical Ca | Completed | 535 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| NVS-6360 | Novartis | Approved | CD38 | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| TAK-8730 | Takeda | Phase 2 | VEGF | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| Semazasiran | BeiGene | Phase 1 | PD-1 | |
| Nidasacituzumab | United Therapeutics | Phase 1/2 | TIM-3 | |
| Pexanesiran | United Therapeutics | Phase 1 | BCMA |