Modality
Cell Therapy
MOA
CAR-T CD19
Target
MDM2
Pathway
Autophagy
NSCLCACC
Development Pipeline
Preclinical
~Jun 2015
→ ~Sep 2016
Phase 1
~Dec 2016
→ ~Mar 2018
Phase 2
Jun 2018
→ Oct 2028
Phase 2Current
NCT04797895
2,062 pts·NSCLC
2018-06→TBD·Recruiting
NCT08577623
496 pts·ACC
2023-08→2028-10·Recruiting
2,558 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-10-082.5y awayPh2 Data· ACC
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
P2
Recruit…
P2
Recruit…
Catalysts
Ph2 Data
2028-10-08 · 2.5y away
ACC
Recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04797895 | Phase 2 | NSCLC | Recruiting | 2062 | NT-proBNP |
| NCT08577623 | Phase 2 | ACC | Recruiting | 496 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| Datoglumide | AbbVie | Approved | CFTR | |
| GSK-7987 | GSK | Phase 3 | MDM2 | |
| AMG-2752 | Amgen | Preclinical | MDM2 | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| SRP-1135 | Sarepta | Phase 2/3 | MDM2 |