Addimmune Prepares to go Public, Initiate Phase Ib HIV Trial

The Rockville-based company, an anticipated SPAC merger of American Gene Technologies HIV business and a 10x Capital Venture Acquisition Corp. III, will list on the New York Stock Exchange under the ticker symbol HIV. The company will have a valuation of $500 million. Funds will be used to advance clinical development of Addimmune’s cell therapy for HIV. 

By Alex Keown | October 31, 2023

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Addimmune, currently American Gene Technologies HIV-focused research, is expected to become a publicly traded company in early 2024 following a merger with 10X Capital Venture Acquisition Corp. III, a special purpose acquisition company (SPAC).

Following the merger with the SPAC company, Addimmune will use the raised funds to support its planned Phase Ib clinical trial assessing the company’s Gag-specific AGT103-T, a genetically modified cell product, CEO Jeff Galvin told BioBuzz. The merger announcement comes months after plans to separate the HIV business were shared by AGT. 

Addimmune launched with the goal of building on the success of a Phase I study assessing AGT103-T as a potential therapeutic for HIV that could offer a functional cure of the disease. Trial data revealed that 100% of participants showed active immune responses to HIV after participants ceased taking their antiretroviral therapy. The data showed that several of the seven trial participants achieved significant viral suppression, which signals the possibility that AGT103-T has the potential to deliver a functional cure to HIV patients. The Phase I data was published in November 2022 in Frontiers in Medicine, a peer-reviewed scientific journal focused on medical advancement. 

“We took people whose viral levels were out of control and we’ve brought them down. These immune responses are highly positive,” Galvin said. “We think this is very exciting data that should be encouraging to the HIV medical community. There is some hope that a cure (for HIV) is likely possible using cell and gene therapy and that we’re on track for it.”

He added that such a cure is not yet within reach but stressed the data his team has so far seen with AGT103-T is providing encouragement. A Phase Ib trial yielding positive data will provide further evidence that a functional cure for HIV, a disease that has claimed the lives of more than 40 million people, is within the grasp of science.

“In the 80s, HIV was a death sentence. It’s now a life sentence of treatment. The best way to end the stigma of HIV is to end the problem,” Galvin said. “The right thing for us to shoot for is where we can put that person (HIV patient) into a stable state, a functional cure.”

The Phase I study provided significant data that will shape the plans for the Phase Ib study. In the Phase I, Galvin noted the overwhelming positive safety data showing no adverse events in any of the patients, including higher dosing levels of AGT103-T. Galvin also noted that patients in the Phase Ib study could cease taking anti-retroviral drugs at an earlier stage than they did in the Phase I study. Study protocols are still being developed.

“The Phase I educated us on the dosing levels and design and protocol for the Phase Ib study.”

When Addimmune initiates the Phase Ib, Galvin said the trial will most likely be conducted at multiple sites on the West Coast. The trial will likely remain small, probably two dozen or so patients, he said.

“Recruitment won’t be a problem. People with HIV are willing to enter this study, even though there are no guarantees. They recognize the risks of taking a new drug. People want it so badly, just on the chance it will make a difference,” he noted.

The Phase Ib could set the stage for a potential Biologics License Application with the FDA.

SPAC mergers have provided multiple life sciences companies with a faster route to list on a public stock exchange. When the SPAC merger is completed in the first quarter of 2024, Galvin estimates Addimmune’s valuation will be approximately $500 million, with an expected earn-out of up to $300 million tied to various clinical and priced-based milestones. Addimmune will trade on the New York Stock Exchange under the ticker symbol HIV.

In addition to supporting the planned Phase Ib trial, some funds will also be used to support business operations, including the expense of the merger, Galvin said.

For Galvin, this will be his first experience taking a company public as a CEO. Earlier in his career, he served on leadership teams of companies that have gone public, so he has some exposure to the process. He credits his legal team as well as internal and external experts who have provided support that has streamlined the process.

When the company goes public, Galvin anticipates the need for Addimmune to scale. While he said the company has the C-suite leadership it needs already in place, he does expect to bolster leadership with additional vice positions. He also pointed to the company’s new board of directors, which he also expects will expand.