Modality
Vaccine
MOA
Cl18.2
Target
MALT1
Pathway
Sphingolipid
PSPPNH
Development Pipeline
Preclinical
~Nov 2013
→ ~Feb 2015
Phase 1
~May 2015
→ ~Aug 2016
Phase 2
~Nov 2016
→ ~Feb 2018
Phase 3
~May 2018
→ ~Aug 2019
NDA/BLA
Nov 2019
→ Feb 2027
NDA/BLACurrent
NCT07666630
1,628 pts·PSP
2020-02→TBD·Completed
NCT04872896
28 pts·PSP
2019-11→2027-02·Active
1,656 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-02-2311mo awayPh3 Readout· PSP
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
NDA/BLA
Active
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2027-02-23 · 11mo away
PSP
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07666630 | NDA/BLA | PSP | Completed | 1628 | HAM-D |
| NCT04872896 | NDA/BLA | PSP | Active | 28 | Biomarker |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 | |
| ALN-3958 | Alnylam | Phase 2 | MALT1 | |
| Cevisacituzumab | Alnylam | Preclinical | MALT1 | |
| ION-8812 | Ionis | Phase 1 | MALT1 | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 |