Modality
Nanobody
MOA
KRASG12Di
Target
FcRn
Pathway
STING
CSUBreast Ca
Development Pipeline
Preclinical
~Jun 2020
→ ~Sep 2021
Phase 1
~Dec 2021
→ ~Mar 2023
Phase 2
Jun 2023
→ Jan 2030
Phase 2Current
NCT08694895
213 pts·CSU
2023-06→TBD·Active
NCT03244141
1,309 pts·Breast Ca
2025-10→2030-01·Terminated
1,522 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-10-287mo awayFast Track· CSU
2030-01-143.8y awayPh3 Readout· Breast Ca
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030
P2/3
Active
P2/3
Termina…
Catalysts
Fast Track
2026-10-28 · 7mo away
CSU
Ph3 Readout
2030-01-14 · 3.8y away
Breast Ca
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08694895 | Phase 2/3 | CSU | Active | 213 | Biomarker |
| NCT03244141 | Phase 2/3 | Breast Ca | Terminated | 1309 | SRI-4 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| Zanusertib | AbbVie | Approved | PCSK9 | |
| Pexarelsin | AstraZeneca | Phase 1 | DLL3 | |
| Ivotuximab | GSK | NDA/BLA | GIP-R | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| ITC-879 | Intra-Cellular | Approved | FcRn | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn |