Modality
Gene Therapy
MOA
CDK4/6i
Target
B7-H3
Pathway
NF-κB
ASALSBCC
Development Pipeline
Preclinical
~Jul 2020
→ ~Oct 2021
Phase 1
~Jan 2022
→ ~Apr 2023
Phase 2
Jul 2023
→ Nov 2030
Phase 2Current
NCT06873139
2,927 pts·AS
2023-07→2030-11·Completed
NCT06019306
2,309 pts·ALS
2024-04→2027-10·Terminated
5,236 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-10-261.6y awayPh3 Readout· ALS
2030-11-054.6y awayPh3 Readout· AS
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P2/3
Complet…
P2/3
Termina…
Catalysts
Ph3 Readout
2027-10-26 · 1.6y away
ALS
Ph3 Readout
2030-11-05 · 4.6y away
AS
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06873139 | Phase 2/3 | AS | Completed | 2927 | ORR |
| NCT06019306 | Phase 2/3 | ALS | Terminated | 2309 | EASI-75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| RHH-1969 | Roche | Approved | BET | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| 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 |