American Gene Technologies International, Inc.

All evaluable patients (n=5), demonstrated a significant reduction in Intact Proviral HIV DNA (IPDA) following treatment with AGT103-T ROCKVILLE, MD, USA I July 22, 2025 I American Gene Technologies (AGT) , a clinical-stage biotechnology company focused on cell and gene therapies for infectious diseases, today announced compelling new data from its HIV cure program, AGT103-T, during a late-breaker oral presentation at the 13th International AIDS Society Conference on HIV Science (IAS 2025) in Kigali, Rwanda. The presentation highlighted human clinical data from AGT’s Phase 1 trial evaluating AGT103-T, a cell and gene therapy designed to protect and enhance HIV-specific immune cells. Using a novel, modified Intact Proviral HIV DNA Assay (IPDA) capable of distinguishing vector from viral sequences, AGT reported sustained reductions in intact HIV proviral DNA in all evaluable subjects. “These data provide early evidence that AGT103-T may directly reduce the replication-competent HIV reservoir, a crucial step toward achieving a functional cure,” said Jeff Galvin , CEO of American Gene Technologies. “The results support our belief that genetically modified autologous T cell therapy has the potential to transform HIV treatment paradigms.” Key Findings Presented: These findings represent a significant milestone in AGT’s mission to deliver a durable, immune-based solution to HIV. The data also reinforces the value of AGT103-T as a first-in-class cell and gene therapy platform targeting latent reservoirs, a key obstacle in achieving viral eradication or long-term remission without antiretroviral therapy. “While still preliminary, these clinical outcomes are promising signs that an HIV cure is within reach,” said Dr.Wm David Hardy , AGT Scientific Advisory Board member and veteran HIV researcher. “The ability to establish viral control and, as these data demonstrate in an unprecedented manner, deplete the intact proviral reservoir holds exciting promise for the field.” AGT plans to initiate additional trials in 2026 to further validate these findings in a larger cohort and refine ATI timing and monitoring strategies. The company is actively exploring strategic partnerships to accelerate development and expand access to this novel therapeutic. About AGT103-T AGT103-T is an autologous T cell therapy that genetically modifies a patient’s own cells to resist HIV infection and enhance immune control. The treatment is administered as a single infusion and is being evaluated for its ability to reduce or eliminate the need for lifelong antiretroviral therapy. About American Gene Technologies American Gene Technologies is a pioneering gene and cell therapy company with a robust platform for developing curative treatments for infectious diseases, cancer, and rare disorders. AGT is headquartered in Rockville, Maryland. SOURCE: American Gene Technologies

No reasons were given for the decision nor the delays to the merger timeline. Don’t count on the triumphant return of biotech special purpose acquisition company deals quite yet. Despite Wilbur Ross’ own blank check company making one of the first announcements for the sector this year, it turns out that deal has now died. As set out back in January, Aprinoia Therapeutics—a Massachusetts-based biotech focused on neurodegenerative diseases such as Alzheimer's and progressive supranuclear palsy (PSP)—was due to combine with the SPAC Ross Acquisition at an implied fully diluted transaction equity value of $280 million. At the time, the deal was expected to complete in the first quarter of the year. Now, five months after that deadline, Aprinoia instead announced yesterday afternoon that the two parties had agreed to a “mutual termination” of the deal. No reasons were given for the decision nor the delays to the merger timeline. Ross—who served as U.S. secretary of commerce in the Trump administration—had already personally invested $7.5 million through a convertible note, according to the original announcement, with another $12.5 million due to follow if the merger had completed. The plan was for the newly listed Aprinoia to use these funds to bring its lead product, a positron emission tomography imaging tracer for neurodegenerative diseases, through to commercialization in China. With that funding no longer on the table, it’s unclear how Aprinoia plans to progress any of its imaging agents or an ongoing U.S. phase 1 trial of its lead therapy, a monoclonal anti-tau IgG antibody being investigated for Alzheimer’s, PSP and frontotemporal dementia. The most recent funding infusion for the company was a $40 million series C back in 2021. With Aprinoia having made no other announcements since unveiling the SPAC deal, it’s hard to get a sense of the other facts in play. The biotech hadn’t responded to a request from Fierce Biotech for further information at the time of publication. While SPAC deals were a hot ticket for biotechs to go public a couple of years ago, the rush cooled in 2022 as the industry hit tough times. Since then, their use has been more sporadic, although 2023 has seen a steady trickle of merger announcements, with August alone seeing U.K. cell therapy developer Celixir and American Gene Technologies’ HIV-focused unit Addimmune unveiling plans to combine with so-called blank check companies. It’s not unheard of for SPAC deals to fall through. Last year saw both gene therapy developer Amicus Therapeutics and fibrosis-focused Blade Therapeutics admit their blank check routes had hit a dead end.

AGT formed the Addimmune spin-off to focus on clinical development and eventual commercialization of a functional cure for HIV. American Gene Technologies (AGT) may be a little bit dizzy with all this spinning. The biotech has inked a blank-check deal for subsidiary Addimmune, signing off the HIV-focused unit to special purpose acquisition company 10X Capital Venture Acquisition Corp. III.  Addimmune spun out from AGT in June, taking a mid-stage HIV cell therapy with it. Now, AGT has entered a deal with 10X III to take the spinoff public, with all non-HIV assets being spun out into a separate entity that will keep AGT’s name. The deal, which is expected to close in the first quarter of 2024, has already been approved by both companies’ board of directors. In relation to the proposal, 10X III and AGT have inked a non-binding letter of intent for a $50 million committed equity facility. Once the deal is final, Addimmune stockholders will move 100% of equity into the combined company. The proposal represents a pre-money enterprise value of $500 million for Addimmune and also offers the potential for $300 million tied to various milestones. Addimmune will trade under ticker symbol “HIV,” with AGT CEO Jeff Galvin set to helm the new company. The biotech’s investigational HIV candidate, dubbed AGT103-T, is a single-dose autologous cell therapy designed to harden T cells against HIV infection and depletion.  In 2021, Addimmune finished a phase 1 trial assessing the therapy in seven patients with HIV. The trial, alongside a separate sponsor-initiated follow-on study, showed active immune responses to HIV up to six months after dosing, according to AGT. The clinical findings are the reason AGT formed the spin-off to focus on clinical development and eventual commercialization of a functional cure for HIV. “We believe that people living with HIV may no longer require lifelong treatment and we imagine a day when this disease no longer causes suffering or claims lives anywhere in the world,” CEO Galvin said in a Aug. 10 release.