WASHINGTON, D.C. (WJLA) — American Gene Technologies, a clinical-stage biotechnology company based in Montgomery County, has taken another step forward in finding a cure for HIV, announcing the first participant of the Phase 1 clinical trial has been infused with the company’s cell and gene therapy product, AGT103-T.
“Very excited," said AGT CEO Jeff Galvin. "This is a huge milestone for the company. There’s still a lot of work to do, but this is an inflection point in the history of our attempt on HIV."
The first infusion took place on May 19 at the Washington Health Institute in Northeast Washington.
“It was about 15 minutes to infuse about 100 milliliters that contains 1 billion HIV-specific T-cells that are immune to HIV and then after that, because now the drug is in their body, essential their cells, those modified cells are the drug, they sit for four hours of observation,” said Galvin.
He told us last year when the company received FDA approval for the trial that the process would require a blood draw to remove a participant’s infected white T-cells from their body.
The cells would be modified to fight the virus and then infused back into the patient after 73 days to make sure it’s safe.
“The only difference between a normal HIV T-cell and the ones we’re putting back in, is that we have made tiny, little modifications that make them impermeable to HIV,” said Galvin.
Jose Bordon, M.D. infused the first patient.
“No side effects. No complications and even more, the patient was smiling and happy and the same, our team was very excited to have this experience," said Bordon.
He took 7News On Your Side to the room where the unidentified male patient took part in Phase 1 of the clinical trial.
Months ago, a blood draw removed infected white T-cells from the patient's body.
They were modified in the lab by adding an element that blocks HIV.
The patient's new and improved white T-cells were then transported to the Washington Health Institute with the help of a container with liquid nitrogen to keep them cold.
They were placed into a machine and warmed up before going back into his body to begin the work to clear HIV.
By Day 7, the patient still hadn't seen any issues.
"We were monitoring whether the patient has any complications. Any complaints, but we haven't seen any," said Bordon. "This is the beginning, the beginning of a very long journey, but the beginning is one step and this is one step forward."
Galvin says it’s not like a traditional drug going through a Phase 1 clinical trial that leads to safety data.
The first-in-human study for AGT103-T, like other gene and cell therapy trials, could give an efficacy signal as well since the participants already have HIV.
Participants treated will be followed for six months in the safety study.
After that, the company says, participants will be enrolled in an FDA-mandated 15-year long follow-up, which is required for all gene therapy trials.
“Keep your fingers crossed. If the theory holds and we’ve hit the right numbers on this thing, we believe that this is a great shot on goal for a potential HIV functional cure,” said Galvin.
He uses the term “functional” because even if it doesn’t completely remove HIV from a person’s body, it will do a lot of good.
“There may still be tiny bits of HIV in somebody’s body, but it won’t matter,” said Galvin. “Equivalent to a cure, not technically a total cure, although we haven’t ruled out that these cells might clear the body entirely of all HIV.”
If it is successful, a big component will be how much the treatment will cost.
“The question will be, who will price it, right? We’re not sure what will happen with the project. Will we commercialize it? Will we partner with a pharma company? Will we sell off the product to a pharma company. All that stuff is not yet determined,” said Galvin. “When I look at the economics, the Pharma company that owns this, whether it’s us or somebody else, will make more money off of every HIV patient than they are right now, so they won’t have an incentive to charge more than what I have in mind.”
7News On Your Side asked what he had in mind.
“I hate to say this, but I think that maybe, it could be done somewhere around $500,000 a patient. You go well that’s a lot. It’s only $20,000 to control the virus on the cheapest antiretroviral meds that are available in the United States, but you’re neglecting the $50-$80,000 worth of doctor’s visits, for side effects, right? So even if antiretrovirals were free, it wouldn’t matter. The insurance companies would be spending $2-$3 million in the lifetime of the patient,” he said.