Modality
Radioligand
MOA
HER2
Target
CDK2
Pathway
Innate Imm
HCCSLEBladder Ca
Development Pipeline
Preclinical
~Aug 2014
→ ~Nov 2015
Phase 1
~Feb 2016
→ ~May 2017
Phase 2
Aug 2017
→ Feb 2030
Phase 2Current
NCT08972257
1,773 pts·HCC
2024-11→2030-02·Not yet recruiting
NCT03167352
156 pts·Bladder Ca
2017-08→2028-01·Completed
1,929 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-01-161.8y awayPh3 Readout· Bladder Ca
2030-02-143.9y awayPh3 Readout· HCC
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
P2/3
Complet…
P2/3
Not yet…
Catalysts
Ph3 Readout
2028-01-16 · 1.8y away
Bladder Ca
Ph3 Readout
2030-02-14 · 3.9y away
HCC
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08972257 | Phase 2/3 | HCC | Not yet recr... | 1773 | CfB |
| NCT03167352 | Phase 2/3 | Bladder Ca | Completed | 156 | EASI-75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| PFE-7809 | Pfizer | Phase 1 | DLL3 | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 |