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BPX-601

Phase 1

Prostate Cancer | Gene therapy | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 29, 2026

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07543055A Phase 1 Study of BPX-601 CAR T-Cell Therapy in Adult Participants With Prostate Cancer That Has Returned, is Resistant to Treatment and Has SpreadPHASE1 NOT YET_RECRUITING 36Jun 1, 2026Mar 20, 2031May 29, 2026 -
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Study Endpoints
Primary Endpoints
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Up to 4 years
Occurrence of Dose Limiting Toxicities (DLTs)
Up to Day 28
Occurrence of Adverse Events of Special Interest (AESIs)
Up to 4 years
Secondary Endpoints
Objective response
Up to 4 years
Duration of Response (DoR)
Up to 4 years
Disease control
Up to 4 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BPX-601 monotherapyEXPERIMENTAL -
Interventions
NameTypeDescription
BPX-601GENETICAdministered per protocol
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo

Key Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of hormone-refractory adenocarcinoma of the prostate without pure small cell carcinoma 2. Metastatic, Castration-Resistant Prostate Cancer (mCRPC) with PSA value at screening ≥4 ng/mL that has progressed within 6 months ...

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Competitive Landscape -Prostate Cancer 259 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK7PHASE3Pembrolizumab, Enzalutamide, Ifinatamab deruxtecan, Docetaxel, Prednisone
AstraZeneca PLCAZN20PHASE3olaparib, abiraterone, Saruparib, Abiraterone, Darolutamide
Pfizer Inc.PFE12PHASE3Talazoparib with enzalutamide, PF-06821497, Docetaxel, Enzalutamide, Leuprolide Open Label
Johnson & JohnsonJNJ21PHASE3Apalutamide, Androgen Deprivation Therapy, Niraparib, Abiraterone, Prednisone
Eli Lilly and CompanyLLY9PHASE3Abemaciclib, Abiraterone, Prednisone or Prednisolone, -PNT2002, Enzalutamide
Amgen Inc.AMGN7PHASE3Xaluritamig, Abiraterone, Enzalutamide, Cabazitaxel, Docetaxel
Novartis AG Sponsored ADRNVS28PHASE3177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, ADT, AAA617
Exelixis, Inc.EXEL4PHASE3Cabozantinib, Atezolizumab, Abiraterone, Enzalutamide, Prednisone
Candel Therapeutics, Inc.CADL3PHASE3Aglatimagene besadenovec + valacyclovir, aglatimagene besadenovec, valacyclovir, aglatimagene besadenovec + valacyclovir
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/Prednisolone
BioNTech SE Sponsored ADRBNTX1PHASE3BNT324, Docetaxel, Prednisone/prednisolone
Telix Pharmaceuticals Limited Sponsored ADRTLX3PHASE368Ga-PSMA-11, 177Lu-TLX591, Enzalutamide, Abiraterone, Docetaxel
Sanofi SA Sponsored ADRSNY2PHASE3abiraterone, Docetaxel, Cabazitaxel
Regeneron Pharmaceuticals, Inc.REGN4PHASE2REGN2810, Degarelix, Leuprolide, Docetaxel, BPX-601
Veracyte, Inc.VCYT2PHASE2Darolutamide, Zoladex, Zoladex LA, Decapeptyl sustained release, Depo-Eligard
Kyntra Bio, Inc.KYNB2PHASE2FG-3246, FOR46, Enzalutamide, Pegfilgrastim
Lantheus Holdings IncLNTH3PHASE3Undisclosed
IDEAYA Biosciences, Inc.IDYA3PHASE1IDE-161, Pembrolizumab, IDE034, IDE574, Fulvestrant
Xencor, Inc.XNCR1PHASE2vudalimab
GSK plc Sponsored ADRGSK2PHASE1GSK5471713, GSK5458514
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Recent Changes (Last 90 Days)
MEDIUMMay 29, 2026NCT07543055primaryCompletionDate: changed
MEDIUMMay 29, 2026NCT07543055primaryCompletionDate: changed
MEDIUMMay 29, 2026NCT07543055primaryCompletionDate: changed
LOWMay 26, 2026NCT07543055primaryCompletionDate: changed
LOWMay 24, 2026NCT07543055studyFirstPostDate: changed
LOWMay 21, 2026NCT07543055NEW_TRIAL: changed
LOWMay 21, 2026NCT07543055NEW_TRIAL: changed