Modality
Cell Therapy
MOA
BETi
Target
CDK4/6
Pathway
DDR
EoEPancreatic CaFL
Development Pipeline
Preclinical
~Sep 2015
→ ~Dec 2016
Phase 1
~Mar 2017
→ ~Jun 2018
Phase 2
~Sep 2018
→ ~Dec 2019
Phase 3
~Mar 2020
→ ~Jun 2021
NDA/BLA
Sep 2021
→ Jan 2025
NDA/BLACurrent
NCT03064526
1,550 pts·FL
2021-09→2025-01·Active
1,550 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-01-071.2y agoPh3 Readout· FL
Trial Timeline
Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025
NDA/BLA
Active
Catalysts
Ph3 Readout
2025-01-07 · 1.2y ago
FL
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03064526 | NDA/BLA | FL | Active | 1550 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-179 | Johnson & Johnson | Approved | KRASG12C | |
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| Sovarapivir | AbbVie | Phase 2/3 | IL-13 | |
| BAY-8733 | Bayer | Preclinical | AuroraA | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| BII-1564 | Biogen | Phase 2 | PSMA | |
| Sovanaritide | Argenx | Phase 3 | TNFα | |
| 369-8021 | Hansoh Pharma | Approved | BTK |