Modality
Fusion Protein
MOA
HPK1i
Target
Nectin-4
Pathway
PI3K/AKT
Celiac
Development Pipeline
Preclinical
~Feb 2016
→ ~May 2017
Phase 1
~Aug 2017
→ ~Nov 2018
Phase 2
~Feb 2019
→ ~May 2020
Phase 3
Aug 2020
→ Oct 2030
Phase 3Current
NCT07464413
2,261 pts·Celiac
2020-08→2028-07·Not yet recruiting
NCT03647959
816 pts·Celiac
2023-07→2030-10·Completed
3,077 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-07-252.3y awayPh3 Readout· Celiac
2030-10-204.6y awayPh3 Readout· Celiac
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Not yet…
P3
Complet…
Catalysts
Ph3 Readout
2028-07-25 · 2.3y away
Celiac
Ph3 Readout
2030-10-20 · 4.6y away
Celiac
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07464413 | Phase 3 | Celiac | Not yet recr... | 2261 | ACR20 |
| NCT03647959 | Phase 3 | Celiac | Completed | 816 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-1944 | Pfizer | NDA/BLA | APOC3 | |
| NVS-6974 | Novartis | Preclinical | CD19 | |
| MRK-2473 | Merck & Co | Phase 1/2 | Nectin-4 | |
| ABB-7516 | AbbVie | Phase 3 | PD-L1 | |
| DSN-1421 | Daiichi Sankyo | Phase 3 | Nectin-4 | |
| Bemanesiran | BioNTech | Phase 3 | PLK4 | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 | |
| ION-3857 | Ionis | Preclinical | Nectin-4 | |
| Elrainavolisib | Roivant Sciences | Preclinical | Nectin-4 | |
| COR-9566 | Corcept | Approved | TYK2 |