Modality
Gene Editing
MOA
KIF18Ai
Target
CD20
Pathway
Innate Imm
Cervical CaAlzheimer'sTTR Amyloidosis
Development Pipeline
Preclinical
~Jul 2009
→ ~Oct 2010
Phase 1
~Jan 2011
→ ~Apr 2012
Phase 2
~Jul 2012
→ ~Oct 2013
Phase 3
~Jan 2014
→ ~Apr 2015
NDA/BLA
~Jul 2015
→ ~Oct 2016
Approved
Jan 2017
→ Nov 2031
ApprovedCurrent
NCT04786034
2,215 pts·TTR Amyloidosis
2017-01→2031-11·Terminated
NCT06463605
384 pts·Cervical Ca
2019-12→2031-07·Active
NCT04389862
609 pts·Cervical Ca
2022-03→2025-04·Active
3,208 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-04-2311mo agoPh3 Readout· Cervical Ca
2031-07-165.3y awayPh3 Readout· Cervical Ca
2031-11-065.6y awayPh3 Readout· TTR Amyloidosis
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Termina…
Approved
Active
Approved
Active
Catalysts
Ph3 Readout
2025-04-23 · 11mo ago
Cervical Ca
Ph3 Readout
2031-07-16 · 5.3y away
Cervical Ca
Ph3 Readout
2031-11-06 · 5.6y away
TTR Amyloidosis
ActiveTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04786034 | Approved | TTR Amyloidosis | Terminated | 2215 | PANSS |
| NCT06463605 | Approved | Cervical Ca | Active | 384 | OS |
| NCT04389862 | Approved | Cervical Ca | Active | 609 | CfB |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| JNJ-8637 | Johnson & Johnson | NDA/BLA | CD20 | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Lisolucimab | Novartis | Approved | CD20 | |
| ABB-8985 | AbbVie | Phase 2 | CD20 | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| ARG-3265 | Argenx | Phase 1/2 | CD20 | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 |