Modality
Nanobody
MOA
PI3Ki
Target
FcRn
Pathway
PD-1/PD-L1
CMLMCL
Development Pipeline
Preclinical
~Oct 2014
→ ~Jan 2016
Phase 1
~Apr 2016
→ ~Jul 2017
Phase 2
Oct 2017
→ Aug 2029
Phase 2Current
NCT04085188
994 pts·MCL
2017-10→2028-12·Not yet recruiting
NCT03028542
2,149 pts·MCL
2019-03→2029-08·Active
3,143 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-12-032.7y awayPh2 Data· MCL
2029-08-033.3y awayPh2 Data· MCL
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
P2
Not yet…
P2
Active
Catalysts
Ph2 Data
2028-12-03 · 2.7y away
MCL
Ph2 Data
2029-08-03 · 3.3y away
MCL
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04085188 | Phase 2 | MCL | Not yet recr... | 994 | CR |
| NCT03028542 | Phase 2 | MCL | Active | 2149 | HAM-D |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| Capifutibatinib | Sanofi | Approved | PRMT5 | |
| Rimatenlimab | Novo Nordisk | Phase 2/3 | SGLT2 | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 | |
| Sovafutibatinib | Moderna | Approved | FcRn |