Modality
Cell Therapy
MOA
MALT1i
Target
TIM-3
Pathway
mTOR
PompeBCCLN
Development Pipeline
Preclinical
~Jan 2018
→ ~Apr 2019
Phase 1
~Jul 2019
→ ~Oct 2020
Phase 2
~Jan 2021
→ ~Apr 2022
Phase 3
~Jul 2022
→ ~Oct 2023
NDA/BLA
Jan 2024
→ Oct 2027
NDA/BLACurrent
NCT04473564
2,719 pts·LN
2025-10→TBD·Not yet recruiting
NCT05657890
1,529 pts·Pompe
2024-01→2027-10·Recruiting
4,248 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-10-111.5y awayPh3 Readout· Pompe
Trial Timeline
2024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
NDA/BLA
Recruit…
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2027-10-11 · 1.5y away
Pompe
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04473564 | NDA/BLA | LN | Not yet recr... | 2719 | ACR20 |
| NCT05657890 | NDA/BLA | Pompe | Recruiting | 1529 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-2735 | Johnson & Johnson | Phase 2/3 | Cl18.2 | |
| Riboinavolisib | Johnson & Johnson | Phase 2/3 | GLP-1R | |
| RHH-974 | Roche | Preclinical | JAK1 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| ABB-8985 | AbbVie | Phase 2 | CD20 | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| Sovarelsin | Alnylam | Phase 2/3 | LAG-3 | |
| ITC-6153 | Intra-Cellular | Phase 3 | KRASG12C | |
| Nidasacituzumab | United Therapeutics | Phase 1/2 | TIM-3 | |
| Gelisertib | Samsung Biologics | Approved | IL-23 |