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FDA approves Phase 1 trial for HIV gene therapy

pharmafile | August 24, 2020 | News story | Sales and Marketing CAR T, CAR T cancer therapies, CAR-T 

The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy.

It will investigate the safety, measure key biomarkers and assess surrogate markers of efficacy in its AGT103-T treatment. This requires an 11-day programme which involves extracting blood from an HIV patient and separating their T cells, which are then engineered in a lab to make them immune to HIV.

The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases.

In a paper published in Molecular Therapy: Methods & Clinical Development, the team discussed why they choose this type of gene therapy to treat HIV. They said: “Recent studies in HIV controllers highlighted the importance for HIV-specific CD4 T cells in controlling HIV replication and disease progression. This prompted us to design a cell and gene therapy to reconstitute these critical CD4 T cells. Adoptive, autologous, antigen-specific CD4 T cell therapy is a promising strategy to rebuild an effective immune system against HIV that might improve clinical status and reduce dependence on antiretroviral therapy.

“However, the unique characteristics of HIV infection created barriers to expand HIV-specific CD4 T cells and has prevented, until now, the development of cell and gene therapies with cells enriched for the HIV-specific CD4 T cell subset. We developed an optimized protocol for efficient clinical-scale manufacturing of highly enriched, HIV-specific CD4 T cells that makes application of this method feasible for treating HIV infection.

“The combination of cell enrichment with the ability to protect these cells against HIV-mediated depletion has achieved a new type of immunotherapy for HIV disease.”

The cost of treatment is expected to be around $200,000, but American Gene Technologies believe this will go down as more people receive it and the process of extracting patient’s cells becomes more refined. The Phase 1 trial is expected to be conducted at sites in Baltimore, Maryland and Washington, DC.

38 million people have contracted HIV since its emergence in the 1970s and there is currently no cure. Using a similar technology to CAR T therapies for blood cancers, American Gene Technologies aims to create the first cure.  

Conor Kavanagh

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