Modality
Vaccine
MOA
GLP-1/GIP
Target
PI3Kα
Pathway
Autophagy
Urothelial CaRCC
Development Pipeline
Preclinical
~Aug 2021
→ ~Nov 2022
Phase 1
~Feb 2023
→ ~May 2024
Phase 2
Aug 2024
→ Sep 2029
Phase 2Current
NCT04378904
2,319 pts·RCC
2024-08→2029-09·Not yet recruiting
2,319 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2029-09-103.4y awayPh3 Readout· RCC
Trial Timeline
Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
P2/3
Not yet…
Catalysts
Ph3 Readout
2029-09-10 · 3.4y away
RCC
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04378904 | Phase 2/3 | RCC | Not yet recr... | 2319 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Zanuderotide | Johnson & Johnson | Phase 2/3 | TIGIT | |
| JNJ-8168 | Johnson & Johnson | Phase 2/3 | FLT3 | |
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| AZN-5171 | AstraZeneca | Approved | GLP-1R | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| Pemiinavolisib | Sarepta | NDA/BLA | CD47 | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα |