American Gene Technologies (AGT) in Rockville is ramping up efforts to develop a possible cure for HIV, announcing Friday it has launched a spinoff company that will focus exclusively on HIV, human immunodeficiency virus.
AGT CEO Jeff Galvin explained, “Now we’re launching a new company, Addimmune, to accelerate our research and continue to pursue our mission to cure HIV.”
Addimmune is being launched following a successful Phase 1 HIV gene and cell therapy clinical trial by AGT. Its work will include Phase 2 and Phase 3 clinical trials.
Phase 1 included patients with HIV. Phase 2 will expand the trial and will treat 50 to 100 patients “to firmly establish efficacy levels,” according to a company announcement.
The goal is to one day enable people with HIV to no longer have to take numerous medications daily and constantly worry about transmitting the disease or getting AIDS. The treatment of gene and therapy is a one-time event.
“I founded American Gene Technologies 15 years ago in the wake of the Human Genome Project, inspired by scientific discoveries in viral vectors and other technological advancements in gene and cell therapy. I saw a future where modifying DNA would lead to treatments and cures for formerly intractable diseases,” Galvin said.
AGT’s Phase 1 trial results were submitted to the U.S. Food and Drug Administration. According to Galvin, 100% of the participants experienced no serious adverse events. There was no rejection of the modified T cells even without exposure to the virus, he said.
Despite a relatively long time between infusion of the cure cell therapy and the analytic treatment interruption study, the resulting data was impressive, Galvin said. All participants showed active immune responses to HIV and more than half of them “achieved significant viral suppression,” according to AGT.
Click here to see Addimmune’s video.