American Gene Technologies® announced the launch of a new company — Addimmune™ — to continue to develop gene and cell therapy technologies to cure HIV! Addimmune was created to focus solely on advancing an HIV cure, building upon more than a decade of work by AGT that led to a successful Phase 1 HIV gene and cell therapy clinical trial.
Addimmune will focus solely on advancing an HIV cure, building upon more than a decade of work by AGT that led to a successful Phase 1 HIV clinical trial. AGT will focus on gene and cell therapies for people suffering from monogenic disorders and cancers.
AGT recorded data that meets the primary and secondary endpoints of its AGT103-T Phase 1 trial. The Phase 1 trial demonstrated that 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. Data from this first-in-human study of AGT103-T was published in the medical journal Frontiers.
American Gene Technologies began withdrawing participants from their antiretroviral drugs — this clinical protocol is technically known as analytic treatment interruption (ATI).
The first five participants treated with AGT103-T were stably engrafted with genetically modified cells. Laboratory studies confirmed substantial increases in virus-specific T cells consistent with improved immunity against HIV in all participants. The early data addresses key trial endpoints and is aligned with the objective of restoring natural immunity against HIV (Press Release).
- The independent Data Safety and Monitoring Board (DSMB) overseeing the trial of American Gene Technologies’ HIV gene therapy found no serious adverse events (SAEs) from the treatment for the third patient and voted unanimously to allow AGT™HIV cure program to continue at a faster pace, eliminating the requirement of DSMB reviews between each participant and moving to quarterly DSMB safety meetings (Press Release).
- First trial participant was infused with AGT103-T in Phase 1 study of American Gene Technologies’ HIV Cure Program (Press Release).
- First trial participant is enrolled in the Phase 1 study for AGT103-T.
- FDA cleared American Gene Technologies to begin Phase 1 clinical trial of HIV cure program.
- American Gene moved its headquarters to a new facility, expanding its lab space.
- Molecular Therapy peer-reviewed article was published by American Gene and NIAID. It showed promising preclinical data for a potential HIV functional cure.
- American Gene was granted three more patents protecting its Immuno-Oncology asset.
- USPTO granted American Gene Technologies two new patents to protect its HIV and cancer assets.
- American Gene Launches Oncology Science Advisory Group (OSAG) to accelerate research for a cancer cure.
- Signed Research Collaboration Agreement with NIAID for experimental HIV/AIDS cure strategy.
- American Gene invited and attended the 2019 J.P. Morgan Healthcare Conference.
- American Gene Technologies granted FDA Orphan Drug Designation for its treatment of Phenylketonuria (PKU).
- USPTO granted American Gene five new patents to protect its HIV and cancer assets.
- Previous scientific advisor, Robert R. Redfield, M.D., was appointed Director of the Centers for Disease Control and Prevention (CDC).
- Completes process development for the AGT103-T automated cell manufacturing protocol.
- American Gene successfully closed Series D financing.
- GMP vector for the HIV cure project was completed, and the automated GMP cell-processing protocol was locked. Successive pilot runs yielded confirming data regarding the ability to generate sufficient numbers of protected target cells for the cell therapy.
- American Gene Technologies used a registered (non-IND) clinical trial to gather HIV-infected persons’ blood to test the cell manufacturing and final vector in order to produce the required data for the IND document to be submitted to the FDA, and to validate the treatment protocol before moving into clinical trials.
- American Gene Technologies had a successful pre-IND meeting with the FDA for AGT103, an HIV cure. This meeting launched the IND development process and the planned clinical trial.
- The company filed patents for unique drug candidates that demonstrated high efficacy against the HIV virus in preliminary tests.
- American Gene Technologies continued to target its drug development efforts toward the projects with the clearest path to clinical studies. This work resulted in advanced genetic vector developments for HIV/AIDS, liver cancer and phenylketonuria (PKU).
- The company received an NIH grant for development of familial dysautonomia (FD) blindness therapeutic, initiated mouse studies on HCC with Dr. Dean Felsher at Stanford, and initiated its Phenylketonuria (PKU) project with University Pittsburgh Children’s Hospital.
- The company welcomed former Wisconsin Governor and U.S. Secretary of Health and Human Services Tommy Thompson as a senior advisor.
- American Gene also successfully closed Series C financing.
- American Gene Technologies continued to deepen its expertise in HIV while also initiating two new drug development programs and established collaborations with leading scientists. These programs included: 1) Gene therapy treatment of Parkinson’s disease, in collaboration with Dr. Ted Dawson, Director of the Institute for Cell Engineering at the Johns Hopkins School of Medicine; and, 2) Gene therapy for treatment of Familial Dysautonomia (FD), with Dr. Frances Lefcort, Chair of the Department of Cell Biology & Neuroscience at Montana State University.
- American Gene received funding from the Dysautonomia Foundation for developing an FD therapeutic, as well as from University of Wisconsin for development of the T1DM therapeutic.
- The company completed a Series B round of financing.
- American Gene Technologies completed in vitro studies validating the efficacy of its gene therapeutic for treating HIV/AIDS. The vector targets several HIV and host genes required for viral replication and infection. The therapeutic vector effectively inhibits HIV replication in CD4+ SupT1 cells by over 95% at an MOI of 3, while higher MOI resulted in over 99% inhibition. In addition, transduction of cells with the vector rendered them resistant to HIV infection, and had no effect on cell viability.
- Based on its therapeutic product line development, American Gene completed a Series A Preferred venture capital funding in September 2013, allowing its expansion to new laboratory space as well as expansion of its Research and Development team.
- American Gene Technologies completed mouse studies of HCC (liver cancer). Significant tumor regression was observed in treatment groups and no apparent toxicity was found, while tumors in several control (un-treated) groups continued to grow.
- In addition to the HCC project, American Gene was funded by NIH with two SBIR phase I projects to develop gene therapies for HIV/AIDS and hepatitis C virus (HCV) infection. Potent multiple-component lentiviral vectors with sophisticated safety features were successfully developed for treating HCV infection that drastically inhibited the replication of the HCV reporter strain by 99.7% in in vitro testing.
- American Gene tested more than 50 intermediate and related vectors/plasmids and a final construct with multiple potent anti-HIV RNA inhibitors has been refined for further testing.
- After intensive engineering and tests of dozens of intermediate vectors, American Gene Technologies successfully developed a lentiviral vector carrying multiple anti-tumor components that can potently inhibit the growth of hepatocellular carcinoma (HCC a.k.a. “liver cancer”). In vitro tests were performed on three HCC cell lines, representing different ethnic backgrounds and different cancer stages. The proliferation of all three HCC cell lines were inhibited by more than 90%.
- During this process, RNA interference technology was successfully introduced into American Gene therapeutic vectors as an additional tool to correct human diseases on the cellular level.
- American Gene Technologies tested a revised AG1102 Pancreatic Cancer Therapeutic in vitro with promising results.
- Design work was completed on the Company’s AG1103 Liver Cancer Therapeutic.
- Co-development/Licensing discussions for various indications were initiated with Chinese pharmaceutical companies.
- In vivo testing of American Gene Technologies AG1101 Prostate Cancer Therapeutic in mice yielded positive results.
- American Gene scientists completed construction of a novel virus design targeting tumor suppressor genes in preparation for animal testing.
- Initial testing of AG1102 Pancreatic Cancer Therapeutic was completed.
- American Gene formed its Scientific Advisory Board, with the commitment of leading scientists in the United States and Europe.
- American Gene Technologies scientists designed and tested novel high-expressing multi-gene lentiviral vectors in vitro. Design features included multiple cargo genes, tissue and intracellular targeting elements, and siRNA genes.
- Multiple variations were successfully cloned and tested.