June 21, 2023

Washington Business Journal: Rockville’s AGT Launches Spinout Addimmune

Washington Business Journal

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Washington Business Journal

Addimmune Summary

Original Post in WBJ By: Sara Gilgore

Rockville’s American Gene Technologies is spinning off a new company that will look to raise millions of dollars in funding and potentially go public – with an ambitious goal of curing HIV. 

The private, 16-year-old biotech, which does not yet have a product to market, said Friday it will launch Addimmune, its spinoff charged with advancing a key HIV gene and cell therapy that AGT successfully pushed through an early-stage clinical trial last year. 

The new firm, set for legal formation within the next 60 days, will take over AGT’s Rockville headquarters at 9713 Key West Ave. because “it’s important to keep the HIV project momentum,” Jeff Galvin, founder and CEO of American Gene Technologies, told us. He will lead both companies.

The scientific team and support staff working on the HIV program will shift from AGT to the spinout. Addimmune launches with 50 employees, most from AGT, and expects to hire another 50 people over the next 18 months, Galvin said. That leaves American Gene with 10 to 15 people – and an intention to hire more over the coming months. That number has not yet been determined.

Addimmune is also putting together its corporate board, “made up of globally recognized HIV scientists and pharmaceutical industry innovators,” AGT said in its announcement. 

And it’s identifying manufacturers and trial sites for a phase 2 trial of its HIV treatment candidate, which reprograms the body’s cells and makes them resistant to HIV infection – so the immune system can fight the virus and prevent it from causing AIDS. The study, designed to involve 50 to 100 patients, is slated to start in 2024 or early 2025, and to end in late 2026. That would set the stage for a late-stage study, necessary to eventually seek regulatory approval and commercialize the treatment – though, Galvin said, it’s too early to predict when that could happen. 

To get through the phase 2 study, Addimmune needs to raise “significant capital,” the company said. It doesn’t yet have the total cost of that trial nailed down, but called it “a large expense.” So it will likely aim to raise at least $75 million, Galvin said, which is the same amount AGT had secured to get through the phase 1 trial. 

If the business moves forward with a public offering, “it will likely be late 2023 or 2024,” he said.

 AGT, meanwhile, will remain a private company and plans to move to a new location. It’s now “in negotiations with commercial real estate developers,” Galvin said, declining to disclose details at this point. 

The company said it intends to focus on cancers and monogenic disorders, or those caused by variation in a single gene such as sickle cell anemia, cystic fibrosis and a type of muscular dystrophy. 

Its pipeline includes a treatment candidate for phenylketonuria, or PKU, a rare disorder in which an amino acid builds up in the body and, if untreated, can lead to brain damage, intellectual disabilities and seizures, among other symptoms. The company’s candidate earned orphan drug designation from the Food and Drug Administration in 2018 and is still in its early stages, expected to reach the clinic in 2025, according to AGT.

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