Modality
Bispecific Ab
MOA
HER2
Target
KIF18A
Pathway
T-cell
Hemophilia ACLL
Development Pipeline
Preclinical
~Jan 2015
→ ~Apr 2016
Phase 1
~Jul 2016
→ ~Oct 2017
Phase 2
Jan 2018
→ Sep 2030
Phase 2Current
NCT05703501
2,847 pts·CLL
2018-01→2030-09·Recruiting
NCT05314277
1,659 pts·CLL
2022-06→2030-09·Recruiting
4,506 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2030-09-044.4y awayPh3 Readout· CLL
2030-09-114.4y awayPh3 Readout· CLL
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P2/3
Recruit…
P2/3
Recruit…
Catalysts
Ph3 Readout
2030-09-04 · 4.4y away
CLL
Ph3 Readout
2030-09-11 · 4.4y away
CLL
Recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05703501 | Phase 2/3 | CLL | Recruiting | 2847 | EDSS |
| NCT05314277 | Phase 2/3 | CLL | Recruiting | 1659 | FEV1 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7809 | Pfizer | Phase 1 | DLL3 | |
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| Voxaderotide | Viking Therapeutics | Approved | PD-L1 | |
| DNL-9555 | Denali | Phase 1/2 | KIF18A |