Modality
Cell Therapy
MOA
CDK4/6i
Target
VEGF
Pathway
Hedgehog
HNSCC
Development Pipeline
Preclinical
~Mar 2017
→ ~Jun 2018
Phase 1
~Sep 2018
→ ~Dec 2019
Phase 2
~Mar 2020
→ ~Jun 2021
Phase 3
Sep 2021
→ Mar 2031
Phase 3Current
NCT08287888
1,445 pts·HNSCC
2023-04→2031-03·Recruiting
NCT06992792
2,071 pts·HNSCC
2021-09→TBD·Not yet recruiting
NCT07841885
2,812 pts·HNSCC
2021-10→TBD·Completed
6,328 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2031-03-024.9y awayPh3 Readout· HNSCC
Trial Timeline
Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P3
Not yet…
P3
Complet…
P3
Recruit…
Catalysts
Ph3 Readout
2031-03-02 · 4.9y away
HNSCC
RecruitingCompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08287888 | Phase 3 | HNSCC | Recruiting | 1445 | EASI-75 |
| NCT06992792 | Phase 3 | HNSCC | Not yet recr... | 2071 | FEV1 |
| NCT07841885 | Phase 3 | HNSCC | Completed | 2812 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| RHH-1969 | Roche | Approved | BET | |
| Zanuderotide | Novartis | Phase 1/2 | VEGF | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| TAK-8730 | Takeda | Phase 2 | VEGF | |
| GIL-2011 | Gilead Sciences | Preclinical | VEGF | |
| Bemazumab | Regeneron | Phase 1 | VEGF | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 |