American Gene Technologies International

What American Gene Technologies International does

American Gene Technologies (AGT) is a clinical-stage gene therapy company founded in 2007 by CEO Jeff Galvin and headquartered in Rockville, Maryland. The company is developing a portfolio of genetic medicines using a proprietary lentiviral vector platform targeting infectious disease (HIV), inherited metabolic disorders (Phenylketonuria), and solid tumor cancers via gamma delta T-cell immunotherapy. Its lead asset, AGT103-T, is an autologous CD4 T-cell therapy designed to confer HIV resistance and is currently in Phase 1/2 clinical trials (RePAIR, NCT04561258) following FDA Fast Track Designation; the PKU gene therapy has received FDA Orphan Drug Designation.

The company's technology stack includes the ImmunoTox/AGT401 gamma delta T-cell platform, a Transient Vector capability for non-integrated gene delivery, and a synthetic gene approach for PKU. AGT operates from a 27,000 sq. ft. facility housing vector production and translational science laboratories, supported by a Scientific Advisory Board drawn from NIH, City of Hope, Georgetown, Stanford, Johns Hopkins, and the University of Pittsburgh. The platform is protected by four patents on AGT103-T and eight to eleven patents on the immuno-oncology approach.

AGT is pre-revenue and generates no commercial product sales, funding operations through venture capital (over $78M raised cumulatively as of 2022 disclosures, with continued rounds through 2024). Its go-to-market upon FDA approval will rely on specialty pharmacies and clinical treatment centers under a traditional biotech commercialization model. In 2023, AGT spun out Addimmune as a wholly-owned subsidiary to focus exclusively on HIV functional cure development, with Addimmune pursuing a public listing via a business combination with 10X Capital Venture Acquisition Corp. III.

Name

American Gene Technologies International

Legal name

American Gene Technologies Inc.

Website

https://americangene.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

American Gene Technologies is a clinical-stage gene therapy company developing lentiviral vector-based treatments targeting HIV functional cure (AGT103-T), phenylketonuria, and solid tumor cancers via gamma delta T-cell immunotherapy, serving patients with serious diseases lacking curative options.

Ownership category

akta.pro rank

Product category

Gene Therapy Biotechnology

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Lentiviral Vector Gene Therapy Developers (HLAAACAB)

akta.pro secondary industries

Gene Therapy for Rare/Monogenic Diseases (HLAAACAE), Gene Therapy CMC/Process Development Platforms (capsid engineering, producer cell lines, plasmids, upstream/downstream) (HLAAACAN)

Keywords

• Lentiviral gene therapy
• HIV cure research
• Cancer immunotherapy
• Rare disease treatment
• Cell therapy development

Headquarters

HQ city

Rockville

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Gene Therapy Product Commercialization: Pre-revenue clinical-stage biotechnology company. Revenue will be generated through commercialization of FDA-approved gene therapy products including AGT103-T for HIV, PKU treatment, and immuno-oncology therapies upon successful clinical development and regulatory approval.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels6 records

Core offering

American Gene Technologies is a clinical-stage biotechnology company developing curative gene and cell therapies using a proprietary lentiviral vector platform. Its lead asset AGT103-T is an autologous CD4 T-cell product in Phase 1/2 trials as a potential functional cure for HIV. The company also develops a synthetic gene therapy for Phenylketonuria (PKU) and the ImmunoTox platform (AGT401 vector) for gamma delta T cell-mediated treatment of solid tumors.

Product overview

American Gene Technologies is a clinical-stage biotechnology company developing genetic medicines through a proprietary lentiviral vector gene therapy platform. The company's portfolio includes: AGT103-T, an autologous T-cell therapy currently in Phase 1/2 trials for HIV functional cure; ImmunoTox, a gamma delta T-cell oncology platform for treating solid tumors; and a gene therapy for Phenylketonuria (PKU) with FDA Orphan Drug Designation. The company has spun off Addimmune to focus exclusively on HIV cure development. AGT's platform technology enables rapid development of gene therapies for infectious diseases, cancers, and inherited disorders using lentivirus vectors.

Differentiator

Problem solved

Functional benefit

Brands

• ImmunoTox: Proprietary lentiviral vector platform for gamma delta T cell therapy to treat cancer
• AGT103-T
• Addimmune

Products and services

• AGT103-T Autologous lentiviral vector-modified CD4 T-cell therapy designed to confer resistance to HIV infection and restore HIV-specific immune function; the company's lead clinical-stage product candidate for an HIV functional cure.
• ImmunoTox (AGT401 vector) Lentiviral vector platform that reprograms tumor cells to accumulate phosphoantigen, stimulating gamma delta (Vγ2) T cells to destroy solid tumors while sparing healthy tissue; protected by 11 granted U.S. patents with initial indication focus on hepatocellular carcinoma.
• AGT PKU Gene Therapy Synthetic single-gene replacement therapy for treating Phenylketonuria (PKU), a debilitating inherited metabolic disorder caused by a single broken gene; holds FDA Orphan Drug Designation.

Quantifiable outcome

• Phase 1 trial demonstrated safety with no serious adverse events at low or high doses
• +3 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• National Institutes of Health (NIH)coreStrategic or Co-development PartnerAGT formed partnerships with NIH to advance its treatments. The company's founder Jeff Galvin was introduced to viral vector technology by NIH researcher Roscoe Brady, MD, PhD in 2007, leading to the founding of the company. NIH provides ongoing research collaboration and expertise.
• National Institute of Allergy and Infectious Diseases (NIAID)coreStrategic or Co-development PartnerAfter preliminary review of early immunological data from ATI participants, NIAID re-engaged with American Gene to conduct viral reservoir and B cell measurements, providing critical data about the company's theory as they progress toward a potential HIV cure.
• City of HopeminorStrategic or Co-development PartnerJohn J. Rossi, PhD from City of Hope serves on AGT's Scientific Advisory Board, providing expertise in molecular biology and gene therapy research.
• Georgetown University Medical CenterminorStrategic or Co-development PartnerRobert Clarke, PhD, DSc, Dean for Research and Professor of Oncology at Georgetown University serves on AGT's Scientific Advisory Board and Oncology Science Advisory Group, providing breast cancer research expertise.
• Stanford University School of MedicineminorStrategic or Co-development PartnerDean W. Felsher, MD, PhD from Stanford University School of Medicine serves on AGT's Scientific Advisory Board.
• University of PittsburghminorStrategic or Co-development PartnerJerry Vockley, MD, PhD, Division Chief of Medical Genetics at Children's Hospital of Pittsburgh of UPMC, serves on AGT's Scientific Advisory Board and PKU Science Advisory Group.
• Johns Hopkins UniversityminorStrategic or Co-development PartnerW. David Hardy, MD, AAHIVS, Adjunct Professor of Medicine at Johns Hopkins University School of Medicine serves on AGT's HIV Science Advisory Group.
• BioHealth Innovation, Inc.coreStrategic or Co-development PartnerBioHealth Innovation (BHI) sources and evaluates market-relevant biohealth intellectual properties, connects IP with funding, and assists businesses in marketing and growth. CEO Rich Bendis collaborates with AGT CEO Jeff Galvin to discuss the BioHealth Capital Region ecosystem.

Scale indicators7 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Sangamo Therapeutics: Sangamo is a clinical-stage gene therapy company using zinc finger nucleases and other genomic engineering tools to develop therapies for genetic diseases and infectious disease (notably HIV, with historical SB-913 and SB-728 programs). Highly comparable to AGT in modality (ex vivo gene-modified cell therapy) and target indications including HIV mononuclear cell modification.
• CRISPR Therapeutics: CRISPR Therapeutics develops ex vivo and in vivo CRISPR/Cas9-based gene-editing therapies (Casgevy for sickle cell and beta-thalassemia). Comparable to AGT as a gene-editing/gene-therapy clinical biotech pursuing functional cures for serious diseases using modified cell products.
• Editas Medicine: Editas Medicine is a clinical-stage gene editing company developing CRISPR-based medicines for serious diseases including sickle cell, retinal, and oncology indications. Comparable as a peer in clinical-stage genomic medicines targeting durable/cure outcomes via ex vivo cell modification.
• Excision BioTherapeutics: Excision is a clinical-stage gene therapy company developing CRISPR-based cures for infectious diseases including HIV. Directly comparable to AGT as the leading HIV-cure-gene-therapy peer; both are pursuing in vivo or ex vivo gene-editing/therapy approaches to eliminate latent HIV reservoirs and displace antiretroviral therapy.
• bluebird bio: bluebird bio develops lentiviral vector-based gene therapies for genetic diseases (e.g., beta-thalassemia, sickle cell, cerebral adrenoleukodystrophy). Shares the same lentiviral vector delivery modality, autologous cell therapy infrastructure, and monogenic disease focus as AGT's PKU and broader gene therapy programs.
• Adaptimmune Therapeutics: Adaptimmune develops engineered T-cell therapies (SPEAR T-cells) for solid tumors, including TCR-based products with established solid-tumor focus. Comparable to AGT's ImmunoTox/gamma-delta T cell solid tumor program; both compete in cell therapy for hard-to-treat solid tumors.
• Lentigen Technology: Lentigen is a lentiviral vector technology and CDMO provider developing lentiviral-transduced cell therapies for oncology and genetic disease. Operates upstream in the same lentiviral vector platform layer that AGT uses for AGT103-T and ImmunoTox, making it both a technology peer and potential manufacturing partner.

Emerging players

• Vor BioPharma: Vor Bio is a clinical-stage cell and gene therapy company focused on engineered hematopoietic stem cells for hematologic cancers and rare diseases. Comparable to AGT in modality (genome-engineered cell therapy) and small-cap clinical-stage biotech footprint.
• Precision BioSciences: Precision BioSciences is a clinical-stage gene editing company developing in vivo and ex vivo ARCUS meganuclease-based therapies for oncology and genetic disease. Comparable to AGT as a fellow smaller-cap clinical gene therapy/editing biotech pursuing allogeneic and autologous engineered cell therapies.
• Verve Therapeutics: Verve is a clinical-stage gene editing company developing in vivo base-editing therapies for cardiovascular disease. Adjacent peer applying gene-editing/correction modality to monogenic and serious disease, sharing the broader gene therapy platform economics and clinical development playbook.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/americangene
• YouTubeyoutube.com/channel/UCqRzAYJ2-W-7pMxhznH03-g
• Facebookfacebook.com/amerigene
• LinkedInlinkedin.com/company/1127234
• Instagraminstagram.com/americangenetechnologies

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries1 record

Funding overview

Funding rounds6 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about American Gene Technologies International