Modality
Gene Therapy
MOA
MDM2i
Target
CD47
Pathway
Autophagy
MCCCrohn's
Development Pipeline
Preclinical
~May 2016
→ ~Aug 2017
Phase 1
~Nov 2017
→ ~Feb 2019
Phase 2
May 2019
→ Jul 2028
Phase 2Current
NCT08959817
2,801 pts·MCC
2025-01→2028-07·Completed
NCT07604784
169 pts·Crohn's
2019-05→2027-08·Completed
2,970 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-08-131.4y awayPh3 Readout· Crohn's
2028-07-172.3y awayPh3 Readout· MCC
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
P2/3
Complet…
P2/3
Complet…
Catalysts
Ph3 Readout
2027-08-13 · 1.4y away
Crohn's
Ph3 Readout
2028-07-17 · 2.3y away
MCC
Completed|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08959817 | Phase 2/3 | MCC | Completed | 2801 | 6MWD |
| NCT07604784 | Phase 2/3 | Crohn's | Completed | 169 | MRD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| Doxacapivasertib | Eli Lilly | Phase 3 | APOC3 | |
| BMY-8678 | Bristol-Myers Squibb | Approved | RET | |
| GSK-4334 | GSK | Preclinical | CD47 | |
| Motainavolisib | Amgen | NDA/BLA | CD47 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| BMR-1165 | BioMarin | Phase 2 | CD47 | |
| INC-2432 | Incyte | Phase 2 | CD47 |