Modality
ASO
MOA
KIF18Ai
Target
KRASG12D
Pathway
STING
CLLBreast CaMyelofibrosis
Development Pipeline
Preclinical
~Apr 2017
→ ~Jul 2018
Phase 1
~Oct 2018
→ ~Jan 2020
Phase 2
~Apr 2020
→ ~Jul 2021
Phase 3
~Oct 2021
→ ~Jan 2023
NDA/BLA
Apr 2023
→ Jun 2030
NDA/BLACurrent
NCT06262790
1,713 pts·Breast Ca
2023-10→2030-06·Active
NCT08251219
2,394 pts·Breast Ca
2023-04→2027-01·Recruiting
4,107 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-01-2710mo awayPh3 Readout· Breast Ca
2030-06-284.2y awayPh3 Readout· Breast Ca
Trial Timeline
Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
NDA/BLA
Recruit…
NDA/BLA
Active
Catalysts
Ph3 Readout
2027-01-27 · 10mo away
Breast Ca
Ph3 Readout
2030-06-28 · 4.2y away
Breast Ca
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06262790 | NDA/BLA | Breast Ca | Active | 1713 | 6MWD |
| NCT08251219 | NDA/BLA | Breast Ca | Recruiting | 2394 | BodyWt |
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 | |
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D |