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Dendritic cell vaccination
Dendritic cell vaccination is a Biologic drug developed by Baylor Research Institute. It is currently in Phase 1 development.
Dendritic cell vaccination involves using autologous dendritic cells loaded with personalized peptides to stimulate the immune system, and has been studied in conditions such as non-small cell lung cancer and hepatitis C. The exact mechanism of dendritic cell vaccination is unknown, but it may involve the interaction with other molecules such as PD-L1.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Dendritic cell vaccination |
|---|---|
| Sponsor | Baylor Research Institute |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
- Cough
- Dyspnea
- Fatigue
- Anorexia
- Alkaline phosphatase
- Nausea
- Glucose, serum-high (hyperglycemia)
- Dizziness
- Low Leukocytes (total WBC) count
- Diarrhea
- Weight loss
- Injection site reaction/extravasation changes
Key clinical trials
- HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer (EARLY_PHASE1)
- Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme (PHASE1, PHASE2)
- Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma (PHASE2)
- Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer (PHASE2)
- IKKb-matured, RNA-loaded Dendritic Cells for Metastasised Uveal Melanoma (PHASE1)
- A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma (PHASE1)
- Preventive Dendritic Cell Vaccination for Lynch Syndrome (PHASE1, PHASE2)
- Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF (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:
- Dendritic cell vaccination CI brief — competitive landscape report
- Dendritic cell vaccination updates RSS · CI watch RSS
- Baylor Research Institute portfolio CI
Frequently asked questions about Dendritic cell vaccination
What is Dendritic cell vaccination?
Who makes Dendritic cell vaccination?
What development phase is Dendritic cell vaccination in?
What are the side effects of Dendritic cell vaccination?
Related
- Manufacturer: Baylor Research Institute — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing