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

biotechnology
genetics
health-care
medical
pharmaceutical

Nr. of Employees

small (1-50)

American Gene Technologies International Inc.

9713 Key West Ave, Suite 500, Rockville, MD 20850-3996


Patents

Methods of producing cells resistant to HIV infection

US-12090200-B2

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HIV pre-immunization and immunotherapy

US-11980663-B2

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Non-integrating viral delivery system and methods related thereto

US-11976292-B2

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HIV pre-immunization and immunotherapy

US-11911458-B2

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Compositions and methods for treating phenylketonuria

US-11820999-B2

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Safe lentiviral vectors for targeted delivery of multiple therapeutic molecules

US-11617760-B2

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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.


Services

Development and validation of automated, GMP‑compliant cell processing protocols and production of clinical‑grade viral vectors to support early‑phase clinical studies.

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.

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.

On‑site CLIA laboratory diagnostic RT‑PCR testing with rapid turnaround times and scalable daily throughput for clinical and community testing needs.

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
  • Show More (8)

Key Technologies

  • Lentiviral vector engineering
  • Non‑integrating viral delivery systems
  • Ex vivo T cell genetic modification
  • GMP viral vector manufacturing
  • Show More (6)

News & Updates

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