American Gene Technologies, a Rockville-based biotech firm, announced on Friday that it was standing up a new company to oversee its HIV treatment project, which recently completed Phase 1 of its clinical trial.
"When we did the efficacy part of the Phase 1 trial, we got really encouraging data that makes us believe that we're on track for a potential solution for people that are living with HIV to return them to a normal life with a one-and-done treatment," AGT's founder and CEO Jeff Galvin told Patch on Wednesday. "They can never infect anybody. They can never get AIDS and they can never re-contract HIV, which is a dream come true for 38 million people on Earth."
AGT was so confident in the results from its Phase 1 clinical trial that it has decided to launch a new company, Addimmune, to focus on the clinical development of the HIV functional cure, according to Galvin.
"The HIV data is so good, and so many people are dealing with HIV, that we're going to spin it out and we're going to staff that and fund it for the sole purpose of advancing that project," he said. "That's no guarantee. It's very important that we don't overpromise to a bunch of people that have been waiting a long, long time — over 40 years — to see a solution."
AGT will attempt to lift Addimmune into the public markets to gain public funding to help accelerate the research and development of the company's HIV functional cure project.
"We think that the data justifies a public interest and that interest from the public would also drive a solution," Galvin said. "We think the critical mass is developed, where Wall Street would see this as being beneficial from an economic standpoint for them, and that the public would be interested in engaging and being equity holders in the company. If that were to happen, that would be another thing that would put pedal to metal on this promising research."
On Friday, AGT released the following data from its HIV Phase 1 clinical trial that showed the following results:
- 100 percent of the participants experienced no serious adverse events.
- 100 percent of the participants’ modified T cells were engrafted, expanded after infusion, and maintained reactivity to HIV.
- There was no rejection of the cells that continued to be detected in patients, even without exposure to the virus, until the last measurement at 180 days.
- There were no differences in safety between the low-dose and high-dose gene therapy.
AGT conducted an analytic treatment interruption study of patients who received HIV gene cell therapy. Despite the relatively long time between treatment and the study, all of the participants showed active immune responses to HIV. In addition, several participants demonstrated significant viral suppression, according to the study.
The HIV cure that Addimmune would develop would be designed for patients living with disease.
"They have to be well controlled, so they would have to be on antiretrovirals long enough that they brought their viral load down to undetectable and sustained it there long enough that they've gotten their normal immune system," Galvin said.
That process could take one to three years, depending when the patient was diagnosed and how long they have been receiving antiretroviral treatment.
"They could be ready for a one-time gene cell therapy that would substitute a natural immune response for all those drugs," Galvin said. "With a natural immune response to HIV, you could control the virus, theoretically. The data is suggestive of this as well, that we can get to this point where you could control the virus naturally at levels that are equivalent to taking antiretrovirals every day."
If Addimmune develops a successful gene cell therapy, HIV patients would no longer be dependent on antiretrovirals.
"Without the antiretrovirals, you're eliminating all the side effects," Galvin said. "You eliminate the side effects, you're living a normal life. You still don't have to worry about infecting anybody, getting AIDS or re-contracting HIV."
AGT's Rockville facility currently has 50 employees. With the launch of Addimmune, the company is expected to make 50 additional hires over the next year and could grow to have several hundred employees in the next couple of years, according to Galvin.