Modality
mRNA
MOA
IL-13i
Target
CDK2
Pathway
mTOR
EpilepsyGBM
Development Pipeline
Preclinical
~Jun 2015
→ ~Sep 2016
Phase 1
~Dec 2016
→ ~Mar 2018
Phase 2
Jun 2018
→ May 2031
Phase 2Current
NCT08987105
2,185 pts·GBM
2023-05→2031-05·Not yet recruiting
NCT03660032
147 pts·GBM
2018-06→2029-03·Not yet recruiting
2,332 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-03-223.0y awayPh3 Readout· GBM
2031-05-065.1y awayPh3 Readout· GBM
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
P2/3
Not yet…
P2/3
Not yet…
Catalysts
Ph3 Readout
2029-03-22 · 3.0y away
GBM
Ph3 Readout
2031-05-06 · 5.1y away
GBM
Not yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08987105 | Phase 2/3 | GBM | Not yet recr... | 2185 | LiverFat |
| NCT03660032 | Phase 2/3 | GBM | Not yet recr... | 147 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| RHH-7975 | Roche | Phase 3 | FXIa | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| NVS-8902 | Novartis | Preclinical | TROP-2 | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 |