Modality
Gene Therapy
MOA
GLP-1/GIP
Target
CD47
Pathway
Fibrosis
CRC
Development Pipeline
Preclinical
~Feb 2013
→ ~May 2014
Phase 1
~Aug 2014
→ ~Nov 2015
Phase 2
~Feb 2016
→ ~May 2017
Phase 3
~Aug 2017
→ ~Nov 2018
NDA/BLA
Feb 2019
→ Dec 2031
NDA/BLACurrent
NCT06447536
2,672 pts·CRC
2019-11→2029-04·Completed
NCT08303242
403 pts·CRC
2019-02→2031-12·Recruiting
3,075 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-04-103.0y awayPh3 Readout· CRC
2031-12-225.7y awayPh3 Readout· CRC
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Recruit…
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2029-04-10 · 3.0y away
CRC
Ph3 Readout
2031-12-22 · 5.7y away
CRC
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06447536 | NDA/BLA | CRC | Completed | 2672 | OS |
| NCT08303242 | NDA/BLA | CRC | Recruiting | 403 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Zanuderotide | Johnson & Johnson | Phase 2/3 | TIGIT | |
| JNJ-8168 | Johnson & Johnson | Phase 2/3 | FLT3 | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| AZN-5171 | AstraZeneca | Approved | GLP-1R | |
| GSK-4334 | GSK | Preclinical | CD47 | |
| Motainavolisib | Amgen | NDA/BLA | CD47 | |
| BMR-1165 | BioMarin | Phase 2 | CD47 | |
| INC-2432 | Incyte | Phase 2 | CD47 | |
| Cevifotisoran | Neurocrine | Approved | CD47 | |
| Pemiinavolisib | Sarepta | NDA/BLA | CD47 |