Addimmune will be launching a Phase Ib trial investigating its human immunodeficiency virus (HIV) candidate AGT103-T to review its safety and efficacy as a monotherapy in patients who will not receive standard of care (SOC) treatments.

Addimmune is a subsidiary company of American Gene Technologies with the sole purpose of finding a functional cure for HIV.

The Phase Ib trial will include 24 patients who will undergo leukapheresis to remove T cells. The cells will then be developed and dosed with AGT103-T before they are introduced back into the body, chief medical officer Dr. Marcus Conant told Clinical Trials Arena.

Patients will then be randomised into three arms in a 1:1:1 ratio. In the first arm, patients will be taken off antiretroviral therapy (ART) immediately, which is the current SOC for HIV patients, the second arm will be removed from SOC after 14 days and the third group after 28 days. Patients will be followed up for 16 weeks.

The sponsor will be blinded but neither the patient nor the investigator will be blinded.

Conant says that the company hopes to start enrolling patients, who have been infected for two years, in the coming months across three sites in the US including the City of Hope Hospital, California.

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The Phase Ia safety trial (NCT04561258) dosed seven patients, who remained on ART, and none of them experienced any serious adverse events or rejection.

Patients in the study were monitored for 180 days and the T cells were still found in their bodies, with some even detected after two years, according to Conant.

AGT-103T is a genetically modified autologous T cell therapy transduced with a lentiviral vector. It acts by targeting chemokine receptor (CCR5), reverse transcriptase (RT) enzyme and transactivating response (TAR) element.

HIV landscape

The HIV landscape took a big blow in January 2023 after a Phase III vaccine trial by Johnson and Johnson was terminated due to lack of efficacy in an interim data review.

Other treatments are in the pipeline but they are more targeted to symptom management as opposed to finding a functional cure or prevention of the treatment.

The field has moved on tremendously since the virus was first discovered in the 1980s, going from what has been described as a death sentence to a manageable disease.

According to the World Health Organization (WHO), 1.3 million people were infected with HIV and 630,000 people died from HIV-related causes worldwide in 2022. In the same year, over 63,000 of these incident cases occurred across the seven major markets (7MM), which include the US, UK, Germany, France, Italy, Spain, and Japan, according to GlobalData.

According to GlobalData, the HIV therapeutics market within the 7MM was worth approximately $27bn in 2023.

GlobalData is the parent company of the Clinical Trials Arena.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

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