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p53 gene therapy
p53 gene therapy is a Gene therapy Small molecule drug developed by Shenzhen SiBiono GeneTech Co.,Ltd. It is currently FDA-approved for Head and neck squamous cell carcinoma, Lung cancer. Also known as: no other names, recombinant adenoviral human p53 gene therapy.
This gene therapy delivers functional p53 tumor suppressor gene into cancer cells to restore apoptosis and cell cycle arrest.
This gene therapy delivers functional p53 tumor suppressor gene into cancer cells to restore apoptosis and cell cycle arrest. Used for Head and neck squamous cell carcinoma, Lung cancer.
At a glance
| Generic name | p53 gene therapy |
|---|---|
| Also known as | no other names, recombinant adenoviral human p53 gene therapy |
| Sponsor | Shenzhen SiBiono GeneTech Co.,Ltd |
| Drug class | Gene therapy |
| Target | p53 (tumor suppressor protein) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
p53 is a critical tumor suppressor gene that is frequently mutated or lost in cancers, allowing malignant cells to evade apoptosis and proliferate uncontrollably. This therapy uses an adenoviral vector to introduce wild-type p53 gene directly into tumor tissue, restoring the ability of cancer cells to undergo programmed cell death and halt proliferation. By restoring p53 function, the therapy aims to trigger tumor regression and improve survival in p53-deficient cancers.
Approved indications
- Head and neck squamous cell carcinoma
- Lung cancer
Common side effects
- Fever
- Local injection site reactions
- Flu-like symptoms
- Transient elevation of liver enzymes
Key clinical trials
- Multiplex Mutation Detection Using Mass Spectrometry in Bladder Cancer
- PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) (PHASE2)
- Metformin and Molecular Aging in Prediabetes (NA)
- Navtemadlin and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma (PHASE1)
- Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study (PHASE2)
- Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer (PHASE2)
- Collecting and Storing Tissue From Young Patients With Cancer
- Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia (PHASE1)
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:
- p53 gene therapy CI brief — competitive landscape report
- p53 gene therapy updates RSS · CI watch RSS
- Shenzhen SiBiono GeneTech Co.,Ltd portfolio CI
Frequently asked questions about p53 gene therapy
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Related
- Drug class: All Gene therapy drugs
- Target: All drugs targeting p53 (tumor suppressor protein)
- Manufacturer: Shenzhen SiBiono GeneTech Co.,Ltd — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Head and neck squamous cell carcinoma
- Indication: Drugs for Lung cancer
- Also known as: no other names, recombinant adenoviral human p53 gene therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing