Modality
Bispecific Ab
MOA
AuroraAi
Target
CD123
Pathway
JAK/STAT
EoEHNSCCNSCLC
Development Pipeline
Preclinical
~Jan 2016
→ ~Apr 2017
Phase 1
~Jul 2017
→ ~Oct 2018
Phase 2
~Jan 2019
→ ~Apr 2020
Phase 3
Jul 2020
→ Jun 2031
Phase 3Current
NCT05831822
637 pts·HNSCC
2020-07→TBD·Terminated
NCT07248454
1,948 pts·HNSCC
2023-03→2031-06·Recruiting
2,585 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2031-06-085.2y awayPh3 Readout· HNSCC
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
P3
Termina…
P3
Recruit…
Catalysts
Ph3 Readout
2031-06-08 · 5.2y away
HNSCC
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05831822 | Phase 3 | HNSCC | Terminated | 637 | EFS |
| NCT07248454 | Phase 3 | HNSCC | Recruiting | 1948 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ | |
| REG-7737 | Regeneron | Preclinical | CD123 | |
| REG-861 | Regeneron | Phase 2 | PARP | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| BGN-6990 | BeiGene | Phase 2/3 | BCMA | |
| Semasacituzumab | Jazz Pharma | Phase 2 | AHR | |
| ILM-2412 | Illumina | Phase 3 | PLK4 | |
| Ivotuximab | Madrigal Pharma | Phase 2 | CD123 |