AGT103-T / American Gene Technologies - LARVOL DELTA

Multiple treatment interruptions and protecting HIV-specific CD4 T cells enable durable CD8 T cell response and viral control. (PubMed, Front Med (Lausanne)) - P=N/A, P1 | "In summary, the rise in CD8 counts and the viral suppression observed in 100% of the study participants are novel observations demonstrating that AGT103-T gene therapy when combined with multiple ATIs, is a safe and effective approach for achieving viral control, with viral setpoints consistently below 25,000 copies/mL and relatively stable CD4 T cell counts. We conclude that HIV cure-oriented cell and gene therapy trials should include ATI and may benefit from designs that include multiple ATIs when induction of CD8 T cells is required to establish viral control."

Journal • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Study to Evaluate the Safety of a Gene and Cell Therapy Product in Participants With HIV That is Well-Controlled on Antiretroviral Therapy (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: American Gene Technologies International Inc. | Recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

An Antiretroviral Treatment Interruption (ATI) Study to Evaluate the Impact of Genetically Modified Autologous Cells (AGT103-T) to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy (clinicaltrials.gov) - P=N/A | N=7 | Enrolling by invitation | Sponsor: American Gene Technologies International Inc. | Phase classification: P1 ➔ P=N/A

Phase classification • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4 • CD8

Safety and durability of AGT103-T autologous T cell therapy for HIV infection in a Phase 1 trial. (PubMed, Front Med (Lausanne)) - P=N/A | "Trial participants were conditioned with cyclophosphamide approximately 1 week before receiving a one-time low (< 10 genetically modified CD4+ T cells) or high (≥10 genetically modified CD4+ T cells) dose of AGT103-T, delivering between 2 and 21 million genetically modified cells per kilogram (kg) body weight. Further studies, including antiretroviral treatment interruption, are warranted to evaluate the product's efficacy in HIV disease. www.clinicaltrials.gov, identifier: NCT03215004."

Journal • P1 data • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

An Antiretroviral Treatment Interruption(ATI) Study to Evaluate the Impact of AGT103-T to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy (clinicaltrials.gov) - P1 | N=7 | Enrolling by invitation | Sponsor: American Gene Technologies International Inc.

New P1 trial • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4 • CD8

Long-term Follow-up of Study Participant Treated With Lentiviral-Based Genetically Modified Autologous Cell Product ,AGT103-T (clinicaltrials.gov) - P=N/A | N=7 | Enrolling by invitation | Sponsor: American Gene Technologies International Inc.

New trial • Human Immunodeficiency Virus • Infectious Disease • CD4

"Real Help, Live Up to It! AGT103-T Vacc-C5, Vacc-4x, Pro140, OyaGen HIV eradication, eCD4-Ig Farzan protein, FIT Biotech(now disappeared), Dermavir, N6 antibody, VRC01, SP-01A, VDA KP-1461 Mosaico Ragon institute block n lock gene deserts moved toward vaccine elite control" (@FernandAubry)

Human Immunodeficiency Virus • Infectious Disease • CD4

"AGT103-T and EBT101 😉" (@doublefill)

American Gene Technologies Announces First Trial Participant Enrolled in Phase 1 Study of AGT103-T Against HIV (GlobeNewswire) - "American Gene Technologies (AGT) announced today that the first trial participant was enrolled in the Phase 1 trial of AGT103-T, a new cell and gene therapy for HIV disease. The first trial participant underwent leukapheresis...used for manufacturing the AGT103-T cell product. After manufacturing and required safety testing, the product will be infused back into the trial participant to test product safety and effects on the immune system."

Trial status • Human Immunodeficiency Virus

Study to Evaluate the Safety of a Gene and Cell Therapy Product in Participants With HIV That is Well-Controlled on Antiretroviral Therapy (clinicaltrials.gov) - P1; N=6; Recruiting; Sponsor: American Gene Technologies International Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Human Immunodeficiency Virus • Infectious Disease

American Gene Technologies to Present at 2020 Virtual Cell & Gene Meeting on the Mesa (Streetinsider.com) - "American Gene Technologies (AGT)...announced today that CEO Jeff Galvin will present at the annual Cell & Gene Meeting on the Mesa. The meeting will be held virtually October 12-16. Galvin’s presentation will highlight the company's technology, including AGT103-T, a therapeutic intended to cure HIV, which is scheduled to begin Phase 1 clinical trials this month."

Clinical • Live event • Human Immunodeficiency Virus

Study to Evaluate the Safety of a Gene and Cell Therapy Product in Participants With HIV That is Well-Controlled on Antiretroviral Therapy (clinicaltrials.gov) - P1; N=6; Not yet recruiting; Sponsor: American Gene Technologies International Inc.

Clinical • New P1 trial • Human Immunodeficiency Virus • Infectious Disease

FDA Approves American Gene Technologies (AGT) to Move Forward with Phase 1 Clinical Trial of HIV Cure Program (GlobeNewswire) - "American Gene Technologies (AGT) announced today approval by the FDA (Food and Drug Administration) to begin Phase 1, the first human clinical trial for AGT’s lead HIV program....These sites are expected to begin enrollment in September 2020. AGT hopes to report initial data before the end of the year. AGT’s Phase 1 trial will investigate the safety of AGT103-T, measure key biomarkers and explore surrogate markers of efficacy. AGT103-T is a single-dose, lentiviral vector-based gene therapy..."

IND • P1 data • Trial initiation date • Human Immunodeficiency Virus

GeoVax Reports 2020 Second Quarter Financial Results and Provides Corporate Update (GlobeNewswire) - "GeoVax will provide its novel MVA-VLP-HIV vaccine (MVA62B) for evaluation in an arm of the clinical trial in combination with AGT103-T. AGT has stated its intention to begin recruiting patients for the Phase 1 study in 2020....Patient enrollment for the clinical trial is expected to commence in late 2020.; HIV Vaccines (Preventive)...The Company is now planning for a new Phase 1 human clinical trial (designated HVTN 132) to further assess the safety, tolerability, and immunogenicity (elicited antibody responses) of a prime-boost regimen of GOVX-B11 in combination with protein boost vaccines. Management has expected that HVTN 132 would commence patient enrollment in late 2020, but now anticipates the trial to start during the first half of 2021..."

Trial initiation date • Human Immunodeficiency Virus