American Gene Technologies (AGT) calls its gene therapy, AGT103-T, a “potential cure” for HIV. The drug met “the primary and secondary endpoints of its Phase 1 trial,” the company announced.
AGT, a Biotechnology Innovation Organization (BIO) member, is a clinical-stage biotech company based in Rockville, Maryland.
“AGT103-T, an autologous T cell product that has been modified with the AGT103 lentiviral vector for HIV resistance, was well-tolerated in humans and that these enhanced T cells persist in the body, ready to respond to HIV,” says the trial data published in Frontiers. The trial is the first-in-human study of the product.
“AGT103-T was designed to restore the Gag-specific CD4+ T cell response in persons with chronic HIV disease who are receiving antiretroviral therapy,” says the study.
Trial participants were given “cyclophosphamide approximately 1 week before receiving a one-time low or high dose of AGT103-T, delivering between 2 and 21 million genetically modified cells per kilogram (kg) body weight.”
Almost all blood samples taken six months after the infusion – the last scheduled monitoring visit – contained the genetically modified AGT103-T cells. These cells “coordinated with killer T cells, and persisted in the body, capable of responding to the target HIV peptide upon stimulation.”
“Levels of Gag-specific CD4+ T cells remained high (~2 to 70-fold higher relative to baseline) throughout 3–6 months after infusion,” the data demonstrates. Furthermore, “AGT103-T at low or high doses was safe and effective for improving host T cell immunity to HIV.”
According to AGT CEO and founder Jeff Galvin, their primary goal “concerned safety of the cell product in low and high doses.” The secondary goal included “measuring responses to treatment, the persistence of AGT103-T in vivo, responses to HIV peptide stimulation, and ability to coordinate a killer T cell response to HIV upon stimulation.”
“AGT103-T cells have enhanced RNA interference capabilities against HIV, and lack the CCR5 co-receptor necessary for HIV to enter helper T cells,” modifications which – in combination with their demonstrated durability – “give American Gene™ an optimistic outlook for a functional cure for HIV.”
The company is now expected “to submit the final Phase 1 trial report to the U.S. Food and Drug Administration (FDA) in 2023” and is currently “writing the protocol of Phase 2 for FDA consideration to continue the clinical development of this potential cure for HIV.”
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