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DC1 vaccine
DC1 vaccine is a Biologic drug developed by Roswell Park Cancer Institute. It is currently in Phase 2 development. Also known as: alpha dendritic cell 1 vaccine, Immunotherapy, Dendritic Cell Vaccine.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | DC1 vaccine |
|---|---|
| Also known as | alpha dendritic cell 1 vaccine, Immunotherapy, Dendritic Cell Vaccine |
| Sponsor | Roswell Park Cancer Institute |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer (EARLY_PHASE1)
- Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer (PHASE2)
- Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab (PHASE2)
- DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer (PHASE1)
- Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer (PHASE1)
- A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) (PHASE1)
- Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer (PHASE1)
- Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DC1 vaccine CI brief — competitive landscape report
- DC1 vaccine updates RSS · CI watch RSS
- Roswell Park Cancer Institute portfolio CI
Frequently asked questions about DC1 vaccine
What is DC1 vaccine?
Who makes DC1 vaccine?
Is DC1 vaccine also known as anything else?
What development phase is DC1 vaccine in?
Related
- Manufacturer: Roswell Park Cancer Institute — full pipeline
- Also known as: alpha dendritic cell 1 vaccine, Immunotherapy, Dendritic Cell Vaccine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing