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enadenotucirev

Phase 1

Colorectal Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 9, 2021

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 Enrollment51
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02636036Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial TumorsPHASE1 COMPLETED 51Jan 25, 2016Oct 8, 2021Nov 9, 20216 United States
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Study Endpoints
Primary Endpoints
Incidence, nature and severity of adverse events (safety and tolerability) in study of enadenotucirev administered in combination with a PD-1 inhibitor
12 months

Review of adverse events including serious adverse events (SAEs), adverse events meeting protocol defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death

Maximum Tolerated and/or Maximum Feasible Dose
12 months

Maximum tolerated dose (MTD) / maximum feasible dose (MFD) of enadenotucirev administered IV in combination with nivolumab.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
enadenotucirev and nivolumabEXPERIMENTAL -
Interventions
NameTypeDescription
enadenotucirevBIOLOGICAL -
nivolumabBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Adult males or females aged 18 years or over * Disease status: - Diagnosis of metastatic or advanced CRC, UCC, SCCHN, salivary gland cancer or NSCLC not responding to standard therapy or for whom no standard treatment exists * For patients who have received prior PD-1 / PD-L1 ...

Countries:United States
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Competitive Landscape -Colorectal Cancer 263 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV8PHASE3Telisotuzumab Adizutecan, Telisotuzumab adizutecan, Bevacizumab, Trifluridine/Tipiracil, ABBV-400
Bristol-Myers Squibb CompanyBMY7PHASE3Ipilimumab, Oxaliplatin, Leucovorin, Fluorouracil, Irinotecan
Merck & Co., Inc.MRK6PHASE3Pembrolizumab, Oxaliplatin, Leucovorin, 5-fluorouracil, Irinotecan
Johnson & JohnsonJNJ5PHASE3Amivantamab, Cetuximab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, Oxaliplatin
Pfizer Inc.PFE12PHASE3PF-08634404, Bevacizumab, Chemotherapy, tucatinib, trastuzumab
GSK plc Sponsored ADRGSK6PHASE3Dostarlimab, CAPEOX, FOLFOX, GSK4418959, PD-1 inhibitor
Exelixis, Inc.EXEL5PHASE3XL092, Atezolizumab, Regorafenib, cabozantinib, atezolizumab
Summit Therapeutics IncSMMT3PHASE3Drug: Ivonescimab, Drug: Bevacizumab, AK112, AK117, Oxaliplatin
Natera, Inc.NTRA4PHASE3Capecitabine, Oxaliplatin, Folfirinox, FOLFOX regimen
Agenus Inc.AGEN4PHASE3Balstilimab, Botensilimab, CR6086, AGEN2034
Incyte CorporationINCY2PHASE3INCA33890, Bevacizumab, FOLFOX, Ruxolitinib, Capecitabine
Amgen Inc.AMGN1PHASE3FOLFIRI Regimen, Sotorasib, Panitumumab, Bevacizumab-awwb
Eli Lilly and CompanyLLY8PHASE2LY2157299, Capecitabine, Fluorouracil, LY4066434., Cetuximab
AstraZeneca PLCAZN8PHASE2Datopotamab deruxtecan, Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE2fruquintinib, FOLFIRI, oxaliplatin , levofolinate calcium , 5-FU, panitumumab, mFOLFOX6 + panitumumab combination therapy
Novartis AG Sponsored ADRNVS7PHASE2Dabrafenib, Trametinib, JDQ443, TNO155, tislelizumab
BioNTech SE Sponsored ADRBNTX3PHASE2RO7198457, PM8002, Chemotherapy Regimen 1, BNT314, BNT327
Regeneron Pharmaceuticals, Inc.REGN2PHASE2Cemiplimab + Fianlimab, VV1, Cemiplimab
Revolution Medicines, Inc.RVMD7PHASE1RMC-6291, Elironrasib, Daraxonrasib, RMC-9805, RMC-6236
Veracyte, Inc.VCYT1PHASE3Tislelizumab
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