Modality
Vaccine
MOA
BTKi
Target
B7-H3
Pathway
Incretin
NSCLC
Development Pipeline
Preclinical
~Apr 2014
→ ~Jul 2015
Phase 1
~Oct 2015
→ ~Jan 2017
Phase 2
~Apr 2017
→ ~Jul 2018
Phase 3
Oct 2018
→ May 2031
Phase 3Current
NCT08920893
726 pts·NSCLC
2023-04→2025-09·Not yet recruiting
NCT08803794
2,717 pts·NSCLC
2023-09→2029-09·Terminated
NCT05017853
933 pts·NSCLC
2018-10→2028-05·Active
+1 more trial
5,257 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2025-09-256mo agoPh3 Readout· NSCLC
2028-05-182.1y awayPh3 Readout· NSCLC
2029-09-223.5y awayPh3 Readout· NSCLC
2031-05-025.1y awayPh3 Readout· NSCLC
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
P3
Active
P3
Complet…
P3
Not yet…
P3
Termina…
Catalysts
Ph3 Readout
2025-09-25 · 6mo ago
NSCLC
Ph3 Readout
2028-05-18 · 2.1y away
NSCLC
Ph3 Readout
2029-09-22 · 3.5y away
NSCLC
Ph3 Readout
2031-05-02 · 5.1y away
NSCLC
ActiveCompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08920893 | Phase 3 | NSCLC | Not yet recr... | 726 | 6MWD |
| NCT08803794 | Phase 3 | NSCLC | Terminated | 2717 | ACR20 |
| NCT05017853 | Phase 3 | NSCLC | Active | 933 | 6MWD |
| NCT04452216 | Phase 3 | NSCLC | Completed | 881 | FEV1 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| BMY-3371 | Bristol-Myers Squibb | Phase 3 | WRN | |
| SNY-9600 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-9073 | Sanofi | Phase 2 | B7-H3 | |
| NVO-7840 | Novo Nordisk | Phase 2/3 | B7-H3 | |
| NVO-7872 | Novo Nordisk | NDA/BLA | B7-H3 | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 |