← Pipeline|BIO-IIT-514

BIO-IIT-514

Approved
Source: Trial-derived·Trials: 1
Modality
Gene Editing
MOA
CD3xCD20
Target
USP1
Pathway
Epigenetic
Ewing Sarcoma
Development Pipeline
Preclinical
~Mar 2015
~Jun 2016
Phase 1
~Sep 2016
~Dec 2017
Phase 2
~Mar 2018
~Jun 2019
Phase 3
~Sep 2019
~Dec 2020
NDA/BLA
~Mar 2021
~Jun 2022
Approved
Sep 2022
Sep 2028
ApprovedCurrent
NCT07044952
1,177 pts·Ewing Sarcoma
2022-092028-09·Active
1,177 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2028-09-092.4y awayPh3 Readout· Ewing Sarcoma
Trial Timeline
Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
Approved
Active
Catalysts
Ph3 Readout
2028-09-09 · 2.4y away
Ewing Sarcoma
Active|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT07044952ApprovedEwing SarcomaActive1177HAM-D
Competitors (10)
DrugCompanyPhaseTargetMOA
LLY-1184Eli LillyNDA/BLAC5CD3xCD20
ZanuderotideNovartisPhase 1/2VEGFCD3xCD20
ABB-2476AbbViePhase 1/2USP1FcRni
NVO-1361Novo NordiskPhase 3CD38CD3xCD20
ZorizanubrutinibNovo NordiskPhase 1BTKCD3xCD20
PexamavacamtenDaiichi SankyoNDA/BLATIGITCD3xCD20
ITC-1028Intra-CellularPhase 2BCMACD3xCD20
CevizasiranAcadia PharmaPhase 1/2GPRC5DCD3xCD20
RAR-440UltragenyxPhase 2FLT3CD3xCD20
TezesotorasibEnlivenPhase 2USP1MALT1i