Gradalis
Gradalis is a biotechnology company focused on developing and commercializing personalized cancer therapeutics, notably Vigil, a fully personalized immunotherapy platform. The company aims to advance cancer treatment by harnessing the patient's immune system to identify and destroy cancer cells, with ongoing research, clinical trials, and a focus on innovative, targeted therapies.
Industries
Nr. of Employees
small (1-50)
Gradalis
2545 Golden Bear Drive, Suite 110, Carrollton, TX 75006
Patents
Products
Personalized autologous tumor-cell immunotherapy platform
An investigational therapy platform that uses a patient’s resected tumor tissue as antigen source, performs plasmid-based genetic modification to reduce immunosuppression and increase immune stimulation, then reintroduces irradiated autologous cells to elicit T-cell responses against clonal neoantigens.
Personalized autologous tumor-cell immunotherapy platform
An investigational therapy platform that uses a patient’s resected tumor tissue as antigen source, performs plasmid-based genetic modification to reduce immunosuppression and increase immune stimulation, then reintroduces irradiated autologous cells to elicit T-cell responses against clonal neoantigens.
Services
End-to-end processing of patient tumor tissue, ex vivo genetic modification, irradiation, dose production and storage to support clinical administration.
Protocol development, trial execution across Phase 1–3, safety reporting, and regulatory interaction support for oncology studies.
Molecular profiling, biomarker identification and validation using exome sequencing and gene expression analyses to inform patient stratification.
Assessment and management of individual patient requests for pre-approval access to investigational therapies, including benefit–risk review and supply impact analysis.
End-to-end processing of patient tumor tissue, ex vivo genetic modification, irradiation, dose production and storage to support clinical administration.
Protocol development, trial execution across Phase 1–3, safety reporting, and regulatory interaction support for oncology studies.
Molecular profiling, biomarker identification and validation using exome sequencing and gene expression analyses to inform patient stratification.
Assessment and management of individual patient requests for pre-approval access to investigational therapies, including benefit–risk review and supply impact analysis.
Expertise Areas
- Personalized autologous cell therapy development
- Clinical trial design and execution in oncology
- Plasmid-based gene modulation and RNA interference
- Biomarker discovery and translational correlates
Key Technologies
- Autologous tumor-cell immunotherapy
- Plasmid DNA constructs with bifunctional shRNA
- GM-CSF expression augmentation
- Lipoplex/nanocomplex nucleic acid delivery