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Anti-KIR

Phase 1

Multiple Myeloma | Small molecule | Oncology |Innate Pharma S.A.|Last Updated: Mar 31, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00552396An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Anti-KIR (1-7F9) in Subjects With Multiple MyelomaPHASE1 COMPLETED 32 — — May 1, 2007Jan 1, 2011Mar 31, 20164 United States
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Study Endpoints
Primary Endpoints
Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment
From start of the treatment to end of study

The maximum tolerated dose (MTD) is the highest dose level below the maximum administered dose (MAD) where none or 1 out of 6 subjects have a DLT.

Secondary Endpoints
Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration
Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration
Area Under the Plasma-concentration-time Curve [AUC (INF)] of IPH2101 After Cycle 1 Administration
Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration
Number of Evaluable Patients With Stable Disease. "Evaluable" is Defined as 2 Consecutive M Protein Assessments
From start of the treatment to end of study or disease progression
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Anti-KIR (1-7F9)DRUGhuman monoclonal antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) 2. Bone marrow plasmacytosis \> 10% (as determined by bone marrow aspirate) or plasmacytoma ...

Countries:United States
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Competitive Landscape -Multiple Myeloma 228 trials
CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ30PHASE3Daratumumab, Lenalidomide, Bortezomib, Dexamethasone, Cilta-cel
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax, Etentamig, Carfilzomib
Bristol-Myers Squibb CompanyBMY19PHASE3Mezigdomide, Carfilzomib, Dexamethasone, Daratumumab, Bortezomib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%, Clarithromycin, Dexamethasone, Ixazomib, Pomalidomide
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib, Daratumumab
Regeneron Pharmaceuticals, Inc.REGN12PHASE3Linvoseltamab, Daratumumab, Carfilzomib, Dexamethasone, Pomalidomide
Pfizer Inc.PFE12PHASE3Elranatamab, Lenalidomide, Elotuzumab, Pomalidomide, Dexamethasone
Sanofi SA Sponsored ADRSNY18PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol / Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone, Bortezomib
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040 /kg + G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone, cemsidomide, Elranatamab
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Eli Lilly and CompanyLLY1PHASE1LOXO-338, Pirtobrutinib
Moderna, Inc.MRNA2PHASE1mRNA-2808
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