Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Low dose FRα vaccine · 1 trial · 1 indication
Emergence of B and T cell immunity targeting the folate receptor alpha
| Arm | Type | Description |
|---|---|---|
| Low dose FRα vaccine | EXPERIMENTAL | FRα 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 vaccine | EXPERIMENTAL | FRα 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 + cyclophosphamide | EXPERIMENTAL | Cyclophosphamide 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 + cyclophosphamide | EXPERIMENTAL | Cyclophosphamide 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 |
| Name | Type | Description |
|---|---|---|
| Low dose FRα vaccine | BIOLOGICAL | 165ug per peptide ID injection |
| Cyclophosphamide | DRUG | IV infusion over 1 hour |
| High dose FRα vaccine | BIOLOGICAL | 500ug per peptide ID injection |
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....
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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.
Low dose FRα vaccine is being developed by Marker Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MRKR.
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.
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.
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.'