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delolimogene mupadenorepvec

Phase 1

Malignant Melanoma | Gene therapy | Oncology |Precision BioSciences, Inc.|Last Updated: Sep 19, 2024

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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04123470A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant MelanomaPHASE1 COMPLETED 24Jan 28, 2020Jul 30, 2023Sep 19, 20243 United States, Sweden
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Study Endpoints
Primary Endpoints
Tolerability Evaluated by NCI CTCAE v5.0
Up to 57 weeks post treatment initiation

The AE reporting period begins upon receiving the first LOAd703 and/or atezolizumab treatment and continues until final visit at week 57

Secondary Endpoints
Overall Response Rate
Up to 57 weeks post treatment initiation
Overall Survival
From treatment initiation until last patient last visit, assessed up till 36 months
Antibodies Against LOAd703
Up to 57 weeks post treatment initiation
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TreatmentEXPERIMENTALDelolimogene mupadenorepvec plus atezolizumab
Interventions
NameTypeDescription
delolimogene mupadenorepvecGENETICLOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL
atezolizumabBIOLOGICALAtezolizumab is an anti-PD-L1 antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Pathological confirmation of melanoma. 2. A life expectancy of at least 3 months as per the investigator 3. Valid for Swedish patients: Patients has locally advanced melanoma or metastatic melanoma, but not eligible for complete resection of melanoma Valid for US patients: Pa...

Countries:United StatesSweden
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