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p53 with chemotherapy
A gene therapy that delivers functional p53 tumor suppressor gene to cancer cells to restore apoptosis and cell cycle arrest, used in combination with chemotherapy.
A gene therapy that delivers functional p53 tumor suppressor gene to cancer cells to restore apoptosis and cell cycle arrest, used in combination with chemotherapy. Used for Head and neck squamous cell carcinoma (in combination with chemotherapy), Various solid tumors with p53 deficiency or mutation (in combination with chemotherapy).
At a glance
| Generic name | p53 with chemotherapy |
|---|---|
| Also known as | no other names |
| Sponsor | Shenzhen SiBiono GeneTech Co.,Ltd |
| Drug class | Gene therapy; recombinant adenovirus vector |
| Target | p53 (tumor suppressor protein) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
This is a recombinant adenovirus-mediated p53 gene therapy (Gendicine) that transfects tumor cells with wild-type p53, restoring the tumor suppressor function lost in many cancers. When combined with chemotherapy, it enhances chemosensitivity by enabling p53-dependent apoptosis and DNA damage response in p53-mutant or p53-deficient tumors. The combination approach aims to improve treatment efficacy and overcome chemotherapy resistance.
Approved indications
- Head and neck squamous cell carcinoma (in combination with chemotherapy)
- Various solid tumors with p53 deficiency or mutation (in combination with chemotherapy)
Common side effects
- Fever
- Injection site reactions
- Chemotherapy-related toxicities (enhanced)
- Flu-like symptoms
Key clinical trials
- Tuvusertib in Astrocytoma With ATRX Mutation (PHASE2)
- Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED) (PHASE2)
- PROfiling Based Endometrial Cancer Adjuvant Therapy (NA)
- Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia (PHASE1)
- p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 (PHASE1, PHASE2)
- p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246 (PHASE2)
- Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer (PHASE1)
- Senescence and the Early Ageing Phenotype After Chemotherapy for Testicular Cancer: the SEA-CAT Study (NA)
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 with chemotherapy CI brief — competitive landscape report
- p53 with chemotherapy updates RSS · CI watch RSS
- Shenzhen SiBiono GeneTech Co.,Ltd portfolio CI