Modality
Cell Therapy
MOA
STINGag
Target
MALT1
Pathway
Angiogenesis
Cervical Ca
Development Pipeline
Preclinical
~Jan 2011
→ ~Apr 2012
Phase 1
~Jul 2012
→ ~Oct 2013
Phase 2
~Jan 2014
→ ~Apr 2015
Phase 3
~Jul 2015
→ ~Oct 2016
NDA/BLA
~Jan 2017
→ ~Apr 2018
Approved
Jul 2018
→ Aug 2030
ApprovedCurrent
NCT05373233
2,970 pts·Cervical Ca
2018-07→2029-06·Active
NCT04098640
2,704 pts·Cervical Ca
2025-10→2030-08·Not yet recruiting
5,674 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2029-06-213.2y awayPh3 Readout· Cervical Ca
2030-08-104.4y awayPh3 Readout· Cervical Ca
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
Approved
Active
Approved
Not yet…
Catalysts
Ph3 Readout
2029-06-21 · 3.2y away
Cervical Ca
Ph3 Readout
2030-08-10 · 4.4y away
Cervical Ca
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05373233 | Approved | Cervical Ca | Active | 2970 | PANSS |
| NCT04098640 | Approved | Cervical Ca | Not yet recr... | 2704 | Biomarker |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| RHH-5389 | Roche | Preclinical | RET | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| SNY-5894 | Sanofi | Approved | CFTR | |
| SNY-4496 | Sanofi | Phase 2/3 | CD3 | |
| SNY-5783 | Sanofi | Phase 1/2 | MET | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| DSN-1421 | Daiichi Sankyo | Phase 3 | Nectin-4 | |
| GIL-4361 | Gilead Sciences | Preclinical | PCSK9 | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 |