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Low dose FRα vaccine

Phase 2

Breast Cancer | Monoclonal antibody | Oncology |Marker Therapeutics, Inc.|Last Updated: Jul 19, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Low dose FRα vaccine · 1 trial · 1 indication

Phase 2 1
NCT02593227Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast CancerBreast Cancer
COMPLETED80 Analytics
PHASE2COMPLETED
Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Immune response
3 years

Emergence of B and T cell immunity targeting the folate receptor alpha

Secondary Endpoints

Folate receptor alpha expression
Baseline
Relapse Free Survival
3 years
Safety and tolerability (treatment emergent adverse events and injection site reactions)
3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low dose FRα vaccineEXPERIMENTALFRα peptide vaccine with GM-CSF adjuvant - single ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
High dose FRα vaccineEXPERIMENTALFRα peptide vaccine with GM-CSF adjuvant - triple ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Low dose FRα vaccine + cyclophosphamideEXPERIMENTALCyclophosphamide 300 mg/sqm as a 1 hour IV infusion 3 days prior to first vaccination. Followed by FRα peptide vaccine with GM-CSF adjuvant - ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
High dose FRα vaccine + cyclophosphamideEXPERIMENTALCyclophosphamide 300 mg/sqm as a 1 hour IV infusion 3 days prior to first vaccination. Followed by FRα peptide vaccine with GM-CSF adjuvant - ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence

Interventions

NameTypeDescription
Low dose FRα vaccineBIOLOGICAL165ug per peptide ID injection
CyclophosphamideDRUGIV infusion over 1 hour
High dose FRα vaccineBIOLOGICAL500ug per peptide ID injection
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Female patient, age 18 years or older; 2. Completely resected unilateral or bilateral primary carcinoma of the breast 3. Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures; 4....

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Low dose FRα vaccine

What is Low dose FRα vaccine used for?

Low dose FRα vaccine is an investigational monoclonal antibody being studied for the treatment of breast cancer, specifically in patients with triple negative breast cancer. It is currently in Phase 2 clinical development.

Who makes Low dose FRα vaccine?

Low dose FRα vaccine is being developed by Marker Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MRKR.

What phase is Low dose FRα vaccine in?

Low dose FRα vaccine is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 clinical trial has been completed.

What clinical trials is Low dose FRα vaccine in?

Low dose FRα vaccine has been studied in one clinical trial, NCT02593227, titled 'Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer.' This Phase 2 trial enrolled 80 female patients aged 18 years and older in the United States and has been completed.

Is Low dose FRα vaccine the same as Folate Receptor Alpha Peptide Vaccine?

Yes, Low dose FRα vaccine is also known as Folate Receptor Alpha Peptide Vaccine. The clinical trial NCT02593227 refers to it as 'Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer.'