Modality
Bispecific Ab
MOA
Anti-Aβ
Target
Menin
Pathway
NF-κB
DLBCLEwing Sarcoma
Development Pipeline
Preclinical
~Apr 2010
→ ~Jul 2011
Phase 1
~Oct 2011
→ ~Jan 2013
Phase 2
~Apr 2013
→ ~Jul 2014
Phase 3
~Oct 2014
→ ~Jan 2016
NDA/BLA
~Apr 2016
→ ~Jul 2017
Approved
Oct 2017
→ Apr 2029
ApprovedCurrent
NCT08244331
2,300 pts·DLBCL
2019-05→2029-04·Terminated
NCT06519483
736 pts·Ewing Sarcoma
2018-11→2028-11·Recruiting
NCT05477333
1,495 pts·DLBCL
2017-10→2025-03·Recruiting
4,531 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-03-101.1y agoPh3 Readout· DLBCL
2028-11-202.6y awayPh3 Readout· Ewing Sarcoma
2029-04-133.0y awayPh3 Readout· DLBCL
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
Approved
Recruit…
Approved
Recruit…
Approved
Termina…
Catalysts
Ph3 Readout
2025-03-10 · 1.1y ago
DLBCL
Ph3 Readout
2028-11-20 · 2.6y away
Ewing Sarcoma
Ph3 Readout
2029-04-13 · 3.0y away
DLBCL
RecruitingTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08244331 | Approved | DLBCL | Terminated | 2300 | Biomarker |
| NCT06519483 | Approved | Ewing Sarcoma | Recruiting | 736 | DOR |
| NCT05477333 | Approved | DLBCL | Recruiting | 1495 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| NVS-1475 | Novartis | Phase 2 | Menin | |
| ABB-8696 | AbbVie | Phase 3 | BCMA | |
| BAY-6035 | Bayer | Phase 1 | C5 | |
| VRT-9481 | Vertex Pharma | Phase 1/2 | Menin | |
| Olpainavolisib | Moderna | Phase 1 | Menin | |
| Zenotinib | BioNTech | Phase 1 | CGRP | |
| Cevimavacamten | Denali | NDA/BLA | Menin | |
| RLA-6817 | Relay Therapeutics | Phase 3 | TIGIT | |
| Sovacagene | Relay Therapeutics | Phase 1/2 | Menin | |
| ZEA-9089 | Zealand Pharma | Phase 2/3 | Menin |