Modality
Nanobody
MOA
CFTRmod
Target
FcRn
Pathway
Tau
HNSCC
Development Pipeline
Preclinical
Mar 2022
→ Sep 2026
PreclinicalCurrent
NCT03014323
2,196 pts·HNSCC
2022-09→2026-09·Active
NCT04880483
1,990 pts·HNSCC
2022-03→TBD·Not yet recruiting
4,186 total pts1 indication
Phase 1
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-09-115mo awayInterim· HNSCC
2026-11-228mo awayPh1 Dose Esc· HNSCC
Trial Timeline
Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
Preclinical
Not yet…
Preclinical
Active
Catalysts
Interim
2026-09-11 · 5mo away
HNSCC
Ph1 Dose Esc
2026-11-22 · 8mo away
HNSCC
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03014323 | Preclinical | HNSCC | Active | 2196 | BodyWt |
| NCT04880483 | Preclinical | HNSCC | Not yet recr... | 1990 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| Darafutibatinib | BioNTech | Preclinical | PRMT5 | |
| ALN-8757 | Alnylam | Preclinical | TIGIT | |
| ITC-879 | Intra-Cellular | Approved | FcRn | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn | |
| Ivotuximab | Madrigal Pharma | Phase 2 | CD123 | |
| Talazasiran | Kymera | NDA/BLA | MET |