ROCKVILLE, MD, May 27, 2021 /PR Newswire/ -- American Gene Technologies (AGT), a clinical-stage biotechnology company, announced treatment of the first participant in its Phase I clinical trial to evaluate safety of the cell and gene therapy product AGT103-T. Designated as the RePAIR trial (Restore Potent Antiviral Immune Responses, NCT04561258), participants are infused once with their own CD4 T cells that were enriched, for cells capable of reacting to HIV, and genetically modified to resist infection. The first infusion took place at Washington Health Institute, Washington, D.C. on May 19.
This is a first-in-human study for AGT103-T. The primary endpoint is safety; testing related to secondary endpoints evaluates responses to treatment including changes in the immune response to HIV. Participants treated with AGT103-T will be followed for 6 months in this safety study before enrolling in an FDA-mandated 15-year long-term follow up required for all gene therapy trials. Enrollment, product manufacturing, and treatments are ongoing at AGT’s clinical trial sites.
"Treating the first person with our product is an important step forward and the culmination of design, development, manufacturing, and approval of the product for human testing. We believe this therapy is capable of changing the body’s ability to fight HIV and the first-in-man study signals the first step to understanding what we can achieve with this innovative approach,” said Dr. C. David Pauza, Chief Science Officer.
"This project represents a major step forward in the potency of an approach that has significant theoretical and empirical momentum within the HIV cure scientific community,” stated CEO Jeff Galvin. He continued, “now that we have seen some evidence that the treatment can be tolerated by patients, I believe we will soon see efficacy signal that will be convincing to the scientific community that the cure for HIV has been achieved or is tremendously close. I couldn’t be happier or prouder of the team. I am exceedingly optimistic about the future of this cell therapy and AGT’s eventual contribution to the treatment of HIV.”
HIV Breakthrough at AGT Gets Researchers Closer to the Cure
This Video Provides Details About the First Infusion and AGT's Scientific Research
Today, approximately 37.9 million people worldwide and 1.1 million people in the United States are living with HIV. The U.S. Government has estimated that 38,700 Americans were newly infected with HIV in 2016 and 1.7 million individuals globally were newly infected with HIV in 2018 (HIV.gov).
Since the late 1980s, antiretroviral drugs have restored quality of life to persons living with HIV and have even been used to prevent new infections. However, no approved treatments can cure HIV. AGT seeks to address this unmet medical need.
About American Gene Technologies
American Gene Technologies (AGT) is a clinical-stage cell and gene therapy company focusing on treatments and cures for acquire or inherited diseases and cancer. Operating in Rockville, MD, AGT designs and develops, and tests novel genetic medicines using a gene-delivery platform that accelerates early-stage testing and enables rapid translation to the clinic. The company has an extensive patent portfolio covering gene therapies for HIV disease, Phenylketonuria (PKU), and solid tumor forms of epithelial cancer.
For more information on AGT's Phase 1 clinical trial, visit clinicaltrials.gov (Study Identifier: NCT04561258).
AGT103-T is a genetically modified cell product made from a person's own cells. AGT's approach is unique in that it focuses on repairing the key immune system damage caused by HIV. When HIV infection causes this specific damage, killing of T helper cells required for immunity to HIV, the infected person becomes unable to eliminate the virus and thus, becomes chronically infected. AGT's approach is designed to repair the T helper cell defect and provide durable virus control that is not compromised by HIV strains that vary in sequence or use alternate ways to enter and infect T cells. AGT's AGT103-T HIV therapeutic drug should work to remove infected cells from the body and decrease or eliminate the need for lifelong antiretroviral treatment.
Clinical Trial Update, Spring 2021
This Video Provides Trial Details
Phase 1 Study Timeline:
- In October 2020, the first patient was identified and enrolled in the trial. During that month, they gave a leukopak (a blood draw of immune cells)
- AGT performed their proprietary process involving gene therapy on the patient's leukopak
- Extensive quality controls of the product were performed over 70 days
- The first patient was infused in May 2021
- The Data and Safety Monitoring Board (DSMB) will meet in July 2021 to evaluate the first participant’s safety data and determine if the study can continue
- AGT expects to share data from the open label study as it becomes available
More Details About AGT’s Phase 1:
- NIH institute NIAID, one of the top HIV labs in the world, has replicated AGT’s data in its own labs, validating the remarkable potency of the therapy and its promise for curing HIV.
- In AGT’s therapy, the number of HIV specific immune cells protected and returned to the participants will be nearly 2000 times the number that was achieved in the previous clinical trial by Sangamo Therapeutics, Inc., whose trial was effective in 10% of the treated patients.
Other Related AGT Press Releases:
- American Gene Technologies Announces First Trial Participant Enrolled in Phase 1 Study of AGT103-T Against HIV
- FDA Approves American Gene Technologies (AGT) To Move Forward With Phase 1 Clinical Trial Of HIV Cure Program
- Molecular Therapy Peer-Reviewed Article by AGT and NIAID Outlines Preclinical Data, Shows Potential for HIV Functional Cure
- IND Application Submission To FDA For Phase 1 Trial Of Genetically Modified Autologous Cell Therapy For HIV Announced by American Gene Technologies