Modality
Cell Therapy
MOA
BETi
Target
CD3
Pathway
Autophagy
CF
Development Pipeline
Preclinical
~Aug 2016
→ ~Nov 2017
Phase 1
~Feb 2018
→ ~May 2019
Phase 2
~Aug 2019
→ ~Nov 2020
Phase 3
~Feb 2021
→ ~May 2022
NDA/BLA
Aug 2022
NDA/BLACurrent
NCT07616658
2,839 pts·CF
2022-08→TBD·Not yet recruiting
NCT05896328
2,900 pts·CF
2024-12→TBD·Not yet recruiting
5,739 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-12-134mo agoOrphan Drug· CF
Trial Timeline
Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q4
NDA/BLA
Not yet…
NDA/BLA
Not yet…
Catalysts
Orphan Drug
2025-12-13 · 4mo ago
CF
Not yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07616658 | NDA/BLA | CF | Not yet recr... | 2839 | BodyWt |
| NCT05896328 | NDA/BLA | CF | Not yet recr... | 2900 | CfB |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-179 | Johnson & Johnson | Approved | KRASG12C | |
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| Sovarapivir | AbbVie | Phase 2/3 | IL-13 | |
| SNY-4496 | Sanofi | Phase 2/3 | CD3 | |
| NVO-9630 | Novo Nordisk | Phase 2 | CD3 | |
| BAY-8733 | Bayer | Preclinical | AuroraA | |
| BII-1564 | Biogen | Phase 2 | PSMA | |
| Miriglumide | Alnylam | Phase 3 | CD3 | |
| Sovanaritide | Argenx | Phase 3 | TNFα | |
| 369-8021 | Hansoh Pharma | Approved | BTK |