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← Pipeline|IMM-2816

IMM-2816

Approved
By Immunomedics (Gilead)
Source: Trial-derived·Trials: 4
Modality
ADC
MOA
PD-1i
Target
Cl18.2
Pathway
Tau
LGSADPKDT2D
Development Pipeline
Preclinical
~Dec 2011
→ ~Mar 2013
Phase 1
~Jun 2013
→ ~Sep 2014
Phase 2
~Dec 2014
→ ~Mar 2016
Phase 3
~Jun 2016
→ ~Sep 2017
NDA/BLA
~Dec 2017
→ ~Mar 2019
Approved
Jun 2019
→ Sep 2031
ApprovedCurrent
NCT05018185
2,758 pts·LGS
2019-08→2028-05·Completed
NCT08151065
1,613 pts·T2D
2019-06→2029-09·Terminated
NCT06815771
2,894 pts·ADPKD
2022-02→2030-09·Completed
+1 more trial
10,214 total pts3 indications
CompletedCurrentUpcoming
Catalysts (4)
2028-05-202.1y awayPh3 Readout· LGS
2029-09-143.5y awayPh3 Readout· T2D
2030-09-144.5y awayPh3 Readout· ADPKD
2031-09-065.4y awayPh3 Readout· LGS
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Termina…
Approved
Complet…
Approved
Complet…
Approved
Complet…
Catalysts
Ph3 Readout
2028-05-20 · 2.1y away
LGS
Ph3 Readout
2029-09-14 · 3.5y away
T2D
Ph3 Readout
2030-09-14 · 4.5y away
ADPKD
Ph3 Readout
2031-09-06 · 5.4y away
LGS
CompletedTerminated|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT05018185ApprovedLGSCompleted2758EFS
NCT08151065ApprovedT2DTerminated1613BodyWt
NCT06815771ApprovedADPKDCompleted2894CfB
NCT08656653ApprovedLGSCompleted2949NT-proBNP
Competitors (10)
DrugCompanyPhaseTargetMOA
MavutenlimabJohnson & JohnsonPhase 3Cl18.2Menini
JNJ-2735Johnson & JohnsonPhase 2/3Cl18.2MALT1i
RibosacituzumabRocheApprovedCl18.2KIF18Ai
AdagrazumabNovartisPhase 2/3Cl18.2EZH2i
ZorimavacamtenBristol-Myers SquibbPreclinicalCl18.2CDK4/6i
GSK-7987GSKPhase 3MDM2PD-1i
DoxafotisoranDaiichi SankyoPhase 1Cl18.2WEE1i
NirabrutinibBioNTechPhase 2/3CDK2PD-1i
CevinaritideGenmabPhase 2/3DLL3PD-1i
PRA-419Praxis PrecisionApprovedCl18.2Anti-Aβ