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allovectin-7
allovectin-7 is a Gene therapy / DNA immunotherapy Small molecule drug developed by Vical. It is currently in Phase 3 development for Metastatic melanoma, Cutaneous T-cell lymphoma (mycosis fungoides).
Allovectin-7 is a DNA-based immunotherapy that delivers the HLA-B7 and β2-microglobulin genes directly into tumor cells to enhance immune recognition and rejection.
Allovectin-7 is a gene therapy agent being studied for the treatment of various stages of melanoma, including Stage IV, Stage III, Recurrent, Metastatic, and Melanoma. It works by increasing the ability of the immune system to recognize cancer cells and kill them, through the expression of HLA-B7 and β2 microglobulin.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | allovectin-7 |
|---|---|
| Sponsor | Vical |
| Drug class | Gene therapy / DNA immunotherapy |
| Target | HLA-B7 and β2-microglobulin expression |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Allovectin-7 uses a lipid-based vector to transfect tumor cells with genes encoding HLA-B7 and β2-microglobulin, which are human leukocyte antigens that increase tumor immunogenicity. This allows the immune system to better recognize and attack the modified tumor cells. The approach is designed to convert immunologically 'cold' tumors into 'hot' tumors by increasing MHC class I presentation on the tumor cell surface.
Approved indications
- Metastatic melanoma
- Cutaneous T-cell lymphoma (mycosis fungoides)
Common side effects
- Injection site reactions
- Fever
- Chills
- Fatigue
- Local inflammation
Key clinical trials
- A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma (PHASE3)
- Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma (PHASE2)
- Phase II Trial of Allovectin-7® for Metastatic Melanoma (PHASE2)
- Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma (PHASE3)
- Phase II Trial of Allovectin-7® for Head and Neck Cancer (PHASE3)
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:
- allovectin-7 CI brief — competitive landscape report
- allovectin-7 updates RSS · CI watch RSS
- Vical portfolio CI
Frequently asked questions about allovectin-7
What is allovectin-7?
How does allovectin-7 work?
What is allovectin-7 used for?
Who makes allovectin-7?
What drug class is allovectin-7 in?
What development phase is allovectin-7 in?
What are the side effects of allovectin-7?
What does allovectin-7 target?
Related
- Drug class: All Gene therapy / DNA immunotherapy drugs
- Target: All drugs targeting HLA-B7 and β2-microglobulin expression
- Manufacturer: Vical — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic melanoma
- Indication: Drugs for Cutaneous T-cell lymphoma (mycosis fungoides)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing