Modality
Gene Therapy
MOA
MALT1i
Target
SHP2
Pathway
NF-κB
DLBCLBladder Ca
Development Pipeline
Preclinical
~Jan 2013
→ ~Apr 2014
Phase 1
~Jul 2014
→ ~Oct 2015
Phase 2
~Jan 2016
→ ~Apr 2017
Phase 3
Jul 2017
→ Nov 2031
Phase 3Current
NCT08617807
909 pts·DLBCL
2017-07→2031-03·Active
NCT07426706
1,252 pts·Bladder Ca
2022-06→2031-11·Not yet recruiting
NCT08466656
1,164 pts·DLBCL
2025-04→TBD·Not yet recruiting
+1 more trial
5,426 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2031-03-185.0y awayPh3 Readout· DLBCL
2031-11-165.6y awayPh3 Readout· Bladder Ca
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P3
Active
P3
Active
P3
Not yet…
P3
Not yet…
Catalysts
Ph3 Readout
2031-03-18 · 5.0y away
DLBCL
Ph3 Readout
2031-11-16 · 5.6y away
Bladder Ca
ActiveNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08617807 | Phase 3 | DLBCL | Active | 909 | Biomarker |
| NCT07426706 | Phase 3 | Bladder Ca | Not yet recr... | 1252 | ACR20 |
| NCT08466656 | Phase 3 | DLBCL | Not yet recr... | 1164 | LiverFat |
| NCT05134348 | Phase 3 | Bladder Ca | Active | 2101 | FEV1 |
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 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| ABB-8985 | AbbVie | Phase 2 | CD20 | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 |