Firm working to cure HIV lands LGBTQ investment support – Washington Blade
‘I’m feeling very confident that we’ve got something here,’ said AGT CEO Jeff Galvin.
A multi-million-dollar investment company called Gaingels that specializes in supporting other companies that are LGBTQ supportive or LGBTQ run has invested in the Rockville, Md.-based American Gene Technologies (AGT) firm that is about to begin human testing for a medical treatment it believes can lead to a cure for HIV.
In a joint statement released on Thursday, April 15, the two companies announced that the New York City-based Gaingels made a financial investment in AGT to support AGT’s Phase 1 clinical trial of a product the company calls AGT 103-T, which it says is a genetically modified cell product made from a person’s own cells.
AGT has shown in laboratory tests, which were confirmed last August by the National Institute of Allergies and Infectious Diseases (NIAID), that AGT 103-T was highly effective in enabling infection-fighting human T-cells to completely neutralize HIV from damaging the body’s immune system and causing AIDS-related illness. The first volunteer patient for the clinical trial was expected to receive the treatment next month.
“As the largest investor network focused on supporting and investing in the best venture-backed companies that embrace and value diverse leadership, including LGBTQ+, Gaingels is proud of participating in AGT’s financing,” said Lorenzo Thione, Gaingels’ managing director in a statement.
“Its mission hit uniquely close to home for the LGBTQ+ community given AGT’s focus on creating a functional immunity and thus an effective cure for HIV,” Thione said. “We are resolved on helping the company grow and scale and achieve this uniquely ambitious and important goal, while strengthening its prospects of success by building a culture that reflects the diversity of its executive teams, staff and customers,” he said.
Thione told the Washington Blade this week that Gaingels has a non-mandatory policy of encouraging companies it invests in to adopt LGBTQ nondiscrimination policies for their employees and to support LGBTQ equality and nondiscrimination in their public positions.
When asked about the Gaingels LGBTQ nondiscrimination policy, AGT CEO Jeff Galvin told the Blade this week in a Zoom interview that AGT has always had a strong nondiscrimination policy that covers all employees, including LGBTQ workers.
“Yes, they didn’t even have to ask us to do that,” said Galvin. “That’s always been our policy,” he said.
“This is an environment here where everybody feels safe. We have an exceedingly diverse community here,” Galvin told the Blade. “Of course, we have some gay people in the company. We don’t care whether they tell us, whether they display it outwardly, whether they bring their boyfriend or girlfriend to events,” he said.
“If people want to cross dress around here, we couldn’t care less.” Galvin continued. “If it turns out that one of the boys here was actually born a girl or one of the girls was actually born a boy, the only thing we care about is our mission.”
The U.S. Food and Drug Administration (FDA) approved AGT’s request to begin human clinical trials for its AGT 103-T treatment last August.
Galvin said that after delays caused by COVID restrictions, AGT arranged in October for the first six volunteer patients to have their blood taken, which was then processed in AGT labs for the genetic altering process that the company believes will enable HIV-positive people to completely fight off HIV without the need for anti-retroviral drugs.
Under the AGT treatment procedure, a quantity of blood is taken from an HIV-positive person and subjected to a process called Leukapheresis, which separates a type of white blood cells known as T-cells. The T-cells are then sent to a lab where they are genetically altered in a process developed and patented by AGT to make them resistant to HIV infection and to enable them to neutralize the HIV virus and prevent it from harming the human body.
Galvin said it takes about 11 days for someone’s blood to be processed through Leukapheresis and the genetic alterations to be completed before the blood is ready to be re-infused into the person’s body, with the goal of providing the person with a functional cure of HIV.
But Galvin noted that the FDA, in an abundance of caution, has required AGT to store the treated blood taken from the first six volunteer patients for 70 days and to test it repeatedly to make sure it is not contaminated with a harmful substance or that quantity of the HIV virus has not multiplied to a greater amount than what the patient already had.
The first of the six volunteer patients is expected to have their treated blood re-infused into their body in May. The six volunteers are part of the first round of the Phase I trial, which is limited to determining whether the treatment has any serious side effects and whether it is safe to advance to the Phase II trial, which will assess whether the treatment is effective in enabling those treated to fight off and clear their bodies of HIV.
The second of the six volunteers will not receive the re-infusing of their treated blood until it is determined that the first volunteer has not had a serious side effect.
In a development that has boosted the AGT team’s morale and drawn interest from investors such as Gaingels, Galvin said that AGT’s own round of laboratory testing of its AGT 103-T product about two years ago showed it to be well above 90 percent effective in stopping HIV in the blood taken from HIV-infected people, the highest effectiveness rate ever shown among any researchers working on an HIV treatment or cure.
Galvin, who called the test results “remarkable,” said AGT decided to bring them to the attention of the National Institute of Allergies and Infectious Diseases, which is an arm of the U.S. National Institutes of Health (NIH), for which nationally known AIDS researcher and COVID expert Dr. Anthony Fauci is a top official.
“We have NIAID right down the road and we know them,” Galvin said. “We thought, let’s show it to them and see if they get excited. And they did,” he said. “They said this is so remarkable that we won’t even believe you unless you let us validate this experiment in our own lab,” Galvin told the Blade.
At NIAID’s invitation, AGT signed a collaborative research agreement with NIAID that included providing NIAID with its AGT 103-T formula and process.
“We gave them all of our reagents. We didn’t touch anything in there,” said Galvin. “They did the same exact protocol that we’re doing for this HIV cure attempt. And they got the same exact data.”
In an action that has received considerable attention in the scientific community, NIAID invited AGT to co-author an article about the findings of its study in the prestigious science journal Molecular Therapy. The article appeared in the journal’s July 2020 edition.
“Look, we’re cautiously optimistic,” Galvin told the Blade. “But I’ve got to say my confidence level as a CEO and a guy who’s been on this mission for 13 years and is looking at we’re going to be re-infusing a patient next month, I’m feeling very confident that we’ve got something here.”