American Gene Technologies International Inc.
American Gene Technologies harnesses the power of gene therapy to relieve human suffering from serious diseases. The company is actively pursuing clinical cures for complex diseases, including HIV, cancer, and phenylketonuria, through innovative gene and cell therapies. They focus on developing patent-protected gene therapies and have a strong emphasis on research, clinical trials, and technological advancements in the biotech industry. Recent milestones include successful Phase 1 trials for HIV cure, publication of clinical data, and ongoing development of gene therapies for HIV, PKU, and cancer. The company has received FDA orphan drug designations, secured extensive patents, and attracted significant investment, positioning itself as a leader in the gene and cell therapy industry.
Industries
Nr. of Employees
small (1-50)
American Gene Technologies International Inc.
Rockville, Maryland, United States, North America
Products
Autologous lentivirus‑modified T cell therapy (HIV program)
Single‑administration autologous T cell therapy produced by ex vivo lentiviral modification intended to enable durable control of HIV infection; clinical program includes Phase 1 safety and persistence evaluation and analytic treatment interruption assessments.
Preclinical lentiviral gene therapy candidate for phenylketonuria (PKU)
Lentiviral vector‑based approach intended as a single‑administration genetic medicine to correct the metabolic defect underlying PKU; program has received orphan‑drug recognition.
Viral vector‑based immuno‑oncology platform (preclinical)
Vector platform and associated methods designed to modulate tumor immunity, including approaches to activate gamma‑delta T cells and deliver therapeutic transgenes for oncology indications.
Autologous lentivirus‑modified T cell therapy (HIV program)
Single‑administration autologous T cell therapy produced by ex vivo lentiviral modification intended to enable durable control of HIV infection; clinical program includes Phase 1 safety and persistence evaluation and analytic treatment interruption assessments.
Preclinical lentiviral gene therapy candidate for phenylketonuria (PKU)
Lentiviral vector‑based approach intended as a single‑administration genetic medicine to correct the metabolic defect underlying PKU; program has received orphan‑drug recognition.
Viral vector‑based immuno‑oncology platform (preclinical)
Vector platform and associated methods designed to modulate tumor immunity, including approaches to activate gamma‑delta T cells and deliver therapeutic transgenes for oncology indications.
Services
Cell therapy process development and clinical manufacturing
Development and validation of automated, GMP‑compliant cell processing protocols and production of clinical‑grade viral vectors to support early‑phase clinical studies.
Clinical translational laboratory services
Clinical and translational laboratory services for sample processing, immunological and biomarker assays, and data collection to support preclinical and clinical programs; includes CLIA diagnostic testing capacity.
Research‑grade vector production and preclinical assay support
Production of research‑grade viral vectors for cell and animal studies and support for assay development used in preclinical validation; access to organized vector construct libraries.
Diagnostic RT‑PCR testing services (CLIA)
On‑site CLIA laboratory diagnostic RT‑PCR testing with rapid turnaround times and scalable daily throughput for clinical and community testing needs.
Partnership development and licensing engagements
Partnership development, licensing arrangements and advisory engagements with academic, government and industry organizations to advance preclinical programs and enable co‑development.
Cell therapy process development and clinical manufacturing
Development and validation of automated, GMP‑compliant cell processing protocols and production of clinical‑grade viral vectors to support early‑phase clinical studies.
Clinical translational laboratory services
Clinical and translational laboratory services for sample processing, immunological and biomarker assays, and data collection to support preclinical and clinical programs; includes CLIA diagnostic testing capacity.
Research‑grade vector production and preclinical assay support
Production of research‑grade viral vectors for cell and animal studies and support for assay development used in preclinical validation; access to organized vector construct libraries.
Diagnostic RT‑PCR testing services (CLIA)
On‑site CLIA laboratory diagnostic RT‑PCR testing with rapid turnaround times and scalable daily throughput for clinical and community testing needs.
Partnership development and licensing engagements
Partnership development, licensing arrangements and advisory engagements with academic, government and industry organizations to advance preclinical programs and enable co‑development.
Expertise Areas
- Gene and cell therapy development
- Preclinical-to-clinical translational development
- Clinical trial design and early‑phase execution for cell and gene therapies
- GMP viral vector and cell therapy manufacturing
Key Technologies
- Lentiviral vector engineering
- Non‑integrating viral delivery systems
- Ex vivo T cell genetic modification
- GMP viral vector manufacturing