Modality
Bispecific Ab
MOA
BiTE
Target
PD-1
Pathway
Cell Cycle
CholangiocarcinomaPNHMeso
Development Pipeline
Preclinical
~Jun 2011
→ ~Sep 2012
Phase 1
~Dec 2012
→ ~Mar 2014
Phase 2
~Jun 2014
→ ~Sep 2015
Phase 3
~Dec 2015
→ ~Mar 2017
NDA/BLA
~Jun 2017
→ ~Sep 2018
Approved
Dec 2018
→ Jan 2029
ApprovedCurrent
NCT08361093
2,509 pts·Cholangiocarcinoma
2024-04→2025-11·Terminated
NCT03217716
733 pts·Meso
2023-11→2027-10·Terminated
NCT05164390
1,533 pts·Meso
2018-12→2029-01·Terminated
+1 more trial
6,193 total pts3 indications
CompletedCurrentUpcoming
Catalysts (4)
2025-11-184mo agoPh3 Readout· Cholangiocarcinoma
2027-10-251.6y awayPh3 Readout· Meso
2028-07-052.3y awayPh3 Readout· PNH
2029-01-082.8y awayPh3 Readout· Meso
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029
Approved
Termina…
Approved
Recruit…
Approved
Termina…
Approved
Termina…
Catalysts
Ph3 Readout
2025-11-18 · 4mo ago
Cholangiocarcinoma
Ph3 Readout
2027-10-25 · 1.6y away
Meso
Ph3 Readout
2028-07-05 · 2.3y away
PNH
Ph3 Readout
2029-01-08 · 2.8y away
Meso
RecruitingTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08361093 | Approved | Cholangiocarcinoma | Terminated | 2509 | EDSS |
| NCT03217716 | Approved | Meso | Terminated | 733 | UPCR |
| NCT05164390 | Approved | Meso | Terminated | 1533 | CR |
| NCT07074603 | Approved | PNH | Recruiting | 1418 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-7458 | Johnson & Johnson | Phase 1/2 | PD-1 | |
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| Zanutinib | Bristol-Myers Squibb | Phase 2/3 | APOC3 | |
| Bemarelsin | Daiichi Sankyo | Preclinical | GLP-1R | |
| Pexaosocimab | Daiichi Sankyo | Phase 2 | PD-1 | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| MRN-8133 | Moderna | Phase 2 | PD-1 | |
| BII-8315 | Biogen | NDA/BLA | CDK2 | |
| Semazasiran | BeiGene | Phase 1 | PD-1 | |
| Geliglumide | Samsung Biologics | Phase 1 | Aβ |