Modality
Vaccine
MOA
C5i
Target
PI3Kα
Pathway
RNA Splicing
Prostate Ca
Development Pipeline
Preclinical
~Apr 2016
→ ~Jul 2017
Phase 1
~Oct 2017
→ ~Jan 2019
Phase 2
~Apr 2019
→ ~Jul 2020
Phase 3
Oct 2020
→ Jun 2030
Phase 3Current
NCT08832268
807 pts·Prostate Ca
2020-10→2030-06·Completed
NCT08890452
2,331 pts·Prostate Ca
2021-10→2026-07·Not yet recruiting
3,138 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-07-214mo awayPh3 Readout· Prostate Ca
2030-06-014.2y awayPh3 Readout· Prostate Ca
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
P3
Complet…
P3
Not yet…
Catalysts
Ph3 Readout
2026-07-21 · 4mo away
Prostate Ca
Ph3 Readout
2030-06-01 · 4.2y away
Prostate Ca
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08832268 | Phase 3 | Prostate Ca | Completed | 807 | LiverFat |
| NCT08890452 | Phase 3 | Prostate Ca | Not yet recr... | 2331 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| DSN-2247 | Daiichi Sankyo | NDA/BLA | EZH2 | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα | |
| Sematenlimab | Samsung Biologics | Phase 3 | PI3Kα | |
| ROI-1081 | Roivant Sciences | Phase 1/2 | PI3Kα | |
| Rimabrutinib | Madrigal Pharma | Phase 1/2 | GPRC5D |