Modality
Cell Therapy
MOA
BiTE
Target
USP1
Pathway
Checkpoint
PompeALLOvarian Ca
Development Pipeline
Preclinical
~Jun 2013
→ ~Sep 2014
Phase 1
~Dec 2014
→ ~Mar 2016
Phase 2
~Jun 2016
→ ~Sep 2017
Phase 3
Dec 2017
→ Jun 2029
Phase 3Current
NCT06864695
2,853 pts·ALL
2017-12→2026-08·Completed
NCT05647879
2,715 pts·Pompe
2020-04→2026-04·Not yet recruiting
NCT08627555
34 pts·Ovarian Ca
2017-12→2029-06·Completed
5,602 total pts3 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-04-01tomorrowPh3 Readout· Pompe
2026-08-185mo awayPh3 Readout· ALL
2029-06-053.2y awayPh3 Readout· Ovarian Ca
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
P3
Complet…
P3
Complet…
P3
Not yet…
Catalysts
Ph3 Readout
2026-04-01 · tomorrow
Pompe
Ph3 Readout
2026-08-18 · 5mo away
ALL
Ph3 Readout
2029-06-05 · 3.2y away
Ovarian Ca
CompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06864695 | Phase 3 | ALL | Completed | 2853 | ORR |
| NCT05647879 | Phase 3 | Pompe | Not yet recr... | 2715 | EFS |
| NCT08627555 | Phase 3 | Ovarian Ca | Completed | 34 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| Zanutinib | Bristol-Myers Squibb | Phase 2/3 | APOC3 | |
| Bemarelsin | Daiichi Sankyo | Preclinical | GLP-1R | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| BII-8315 | Biogen | NDA/BLA | CDK2 | |
| Geliglumide | Samsung Biologics | Phase 1 | Aβ | |
| AXS-4984 | Axsome | Preclinical | JAK2 | |
| SND-5878 | Syndax | NDA/BLA | Menin | |
| Tezesotorasib | Enliven | Phase 2 | USP1 |