Modality
Gene Therapy
MOA
AHRant
Target
FcRn
Pathway
Epigenetic
NSCLC
Development Pipeline
Preclinical
~Mar 2016
→ ~Jun 2017
Phase 1
~Sep 2017
→ ~Dec 2018
Phase 2
~Mar 2019
→ ~Jun 2020
Phase 3
Sep 2020
→ Jul 2030
Phase 3Current
NCT05500765
2,982 pts·NSCLC
2023-10→2030-07·Not yet recruiting
NCT05340872
1,126 pts·NSCLC
2020-09→2030-05·Recruiting
4,108 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2030-05-034.1y awayPh3 Readout· NSCLC
2030-07-214.3y awayPh3 Readout· NSCLC
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Recruit…
P3
Not yet…
Catalysts
Ph3 Readout
2030-05-03 · 4.1y away
NSCLC
Ph3 Readout
2030-07-21 · 4.3y away
NSCLC
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05500765 | Phase 3 | NSCLC | Not yet recr... | 2982 | NT-proBNP |
| NCT05340872 | Phase 3 | NSCLC | Recruiting | 1126 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| AZN-5978 | AstraZeneca | Phase 2/3 | GIP-R | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| BII-5449 | Biogen | Phase 3 | FXIa | |
| ITC-879 | Intra-Cellular | Approved | FcRn | |
| Elratapinarof | Halozyme | Phase 2 | C5 | |
| Nidaratamab | Exelixis | Phase 3 | FLT3 | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn |