Modality
Gene Therapy
MOA
PCSK9i
Target
ALK
Pathway
Tau
CLLSCLC
Development Pipeline
Preclinical
~Jul 2012
→ ~Oct 2013
Phase 1
~Jan 2014
→ ~Apr 2015
Phase 2
~Jul 2015
→ ~Oct 2016
Phase 3
Jan 2017
→ Mar 2030
Phase 3Current
NCT03209410
2,275 pts·SCLC
2018-06→2029-05·Completed
NCT03238586
2,970 pts·CLL
2017-01→2030-03·Not yet recruiting
NCT08336762
715 pts·CLL
2019-07→2030-01·Terminated
5,960 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2029-05-203.1y awayPh3 Readout· SCLC
2030-01-173.8y awayPh3 Readout· CLL
2030-03-164.0y awayPh3 Readout· CLL
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
P3
Not yet…
P3
Complet…
P3
Termina…
Catalysts
Ph3 Readout
2029-05-20 · 3.1y away
SCLC
Ph3 Readout
2030-01-17 · 3.8y away
CLL
Ph3 Readout
2030-03-16 · 4.0y away
CLL
CompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03209410 | Phase 3 | SCLC | Completed | 2275 | MRD |
| NCT03238586 | Phase 3 | CLL | Not yet recr... | 2970 | ORR |
| NCT08336762 | Phase 3 | CLL | Terminated | 715 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| GSK-6983 | GSK | Phase 2 | ALK | |
| BAY-3308 | Bayer | Phase 1 | ALK | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| Tixarelsin | Vertex Pharma | Phase 1 | ALK | |
| VRT-6833 | Vertex Pharma | Preclinical | ALK | |
| INC-1261 | Incyte | Phase 1/2 | PRMT5 | |
| Niralucimab | Ionis | Phase 1 | ALK |