Modality
Gene Therapy
MOA
KIF18Ai
Target
WEE1
Pathway
Innate Imm
ThymomaCervical Ca
Development Pipeline
Preclinical
~Dec 2019
→ ~Mar 2021
Phase 1
~Jun 2021
→ ~Sep 2022
Phase 2
Dec 2022
→ Feb 2031
Phase 2Current
NCT07539730
1,231 pts·Cervical Ca
2023-07→2030-12·Not yet recruiting
NCT05328704
1,398 pts·Thymoma
2022-12→2031-02·Completed
2,629 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2030-12-114.7y awayPh3 Readout· Cervical Ca
2031-02-124.9y awayPh3 Readout· Thymoma
Trial Timeline
2023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P2/3
Complet…
P2/3
Not yet…
Catalysts
Ph3 Readout
2030-12-11 · 4.7y away
Cervical Ca
Ph3 Readout
2031-02-12 · 4.9y away
Thymoma
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07539730 | Phase 2/3 | Cervical Ca | Not yet recr... | 1231 | PANSS |
| NCT05328704 | Phase 2/3 | Thymoma | Completed | 1398 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| TAK-2403 | Takeda | Phase 2 | WEE1 | |
| Sovacapivasertib | Amgen | Phase 3 | WEE1 | |
| BMR-8526 | BioMarin | Phase 1/2 | CD38 | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 | |
| Bemanaritide | Blueprint Medicines | Phase 2 | CD38 |