AGT 103-T

American Gene Technologies (AGT) announced it will spin off its Addimmune division as a publicly traded firm via a merger with special purpose acquisition company (SPAC) 10X Capital Venture Acquisition. AGT launched Addimmune in June with a view to having the unit continue its work of developing gene and cell therapies that can offer a functional cure for patients with HIV."We're at the forefront of gene therapy for HIV, working to transform the fear of a lifelong disease into hope for a single-administration, one-and-done cure," remarked AGT's chief executive Jeff Galvin, who will take on the role of CEO at Addimmune.AGT began clinical trials in 2020 for the single-dose, lentiviral-based autologous cell therapy candidate AGT103-T, which is designed to deliver modified HIV-specific CD4 T cells to patients. "It makes gene modifications to the patients' [T cells] that harden those cells against HIV infection and depletion, thus allowing those cells to maintain a normal response to HIV instead of being 'killed' by the virus," the company explained.Addimmune said it completed a Phase I trial for AGT103-T that demonstrated "positive" safety results in seven patients. That trial, along with another sponsor-initiated follow-on study, showed "active immune responses to HIV" up to six months after dosing, the company added. Last month, AGT said testing of AGT103-T had entered a critical phase – allowing participants to voluntarily withdraw from their antiretroviral drugs. Early results for the treatment motivated it to create a spinout focused on completing required clinical trials and pursuing eventual commercialisation, if approved.The proposed SPAC merger deal represents a pre-money enterprise value of $500 million for Addimmune and includes an earnout of up to $300 million tied to various clinical and priced-based milestones. Existing Addimmune stockholders will roll 100% of their equity into equity of the combined company.AGT and 10X Capital expect the merger to be completed in the first quarter of 2024. Prior to the combination, AGT's non-HIV assets will spin-off into an entity that will retain the American Gene Technologies name.

ROCKVILLE, Md., July 15, 2021 (GLOBE NEWSWIRE) -- American Gene Technologies (AGT) announced today that the Data and Safety Monitoring Board (DSMB) voted unanimously to continue AGT’s HIV cure program without modification, after safety analysis of the participant’s data revealed no adverse effects from the treatment. AGT’s Phase 1 trial of AGT103-T, a new cell and gene therapy for HIV disease, is designed to induce durable viral suppression by delivering therapeutic genes to the recipient's immune cells. The cells are collected by leukapheresis, modified outside the body, then re-infused. Once infused, the cells are expected to durably suppress the virus at undetectable levels without the need for antiretroviral treatment. “Safety represents a critical milestone in the project and gives us additional confidence that HIV can be cured,” said Jeff Galvin, CEO. “This milestone supports AGT’s mission to relieve suffering and premature death from serious human diseases. AGT’s HIV cure program is based on a platform that has the capacity to treat other chronic viral infections, as well as monogenic disorders and cancers. Our ImmunoTox program has yielded pre-clinical data showing the potential for revolutionizing solid tumor cancer treatment, and our Phenylketonuria gene therapy may be a one-and-done cure for patients suffering from that inherited disease. A success in HIV would provide sustained funding to accelerate dozens of therapeutics that are within the scope of AGT’s technology platform.” Phase 1 in the Maryland/DC Area AGT’s Phase 1 RePAIR (Restore Potent Antiviral Immune Responses) trial for AGT103-T is currently underway at trial sites in the Maryland / Washington, DC area. The recruitment status of the clinical trial, and information on the trial sites can be found on ClinicalTrials.gov under the identifier NCT04561258. The RePAIR trial is the company’s first step in clinical testing of cell and gene therapies for HIV, cancer, and rare diseases. A video accompanying this announcement is available at About HIV Today, approximately 37.9 million people worldwide, including 1.2 million people in the United States, are living with HIV/AIDS. The U.S. government has estimated that 38,900 Americans were newly infected with HIV and 1.7 million individuals globally were newly infected with HIV in 2018. Locally, the Washington D.C./Baltimore area is often cited as a ‘hot spot’ for HIV with Washington, D.C. having a rate of 46 new infections per year per 100,000 population[1] and Baltimore City has similarly high rates of 45 new infections per 100,000.[2] Maryland also ranks fifth among U.S. states and territories in HIV diagnosis rates, with nearly 1,000 new cases in 2018 alone, according to the Maryland State Department of Health. Since the late 1980s, antiretroviral drugs have prevented AIDS, HIV transmission, and mortality in persons living with HIV and, in some cases, have been used prophylactically to prevent new infections. However, no approved treatments can cure HIV. AGT is committed to addressing this unmet medical need. About AGT103-T AGT103-T is a genetically modified cell product made from a person's own cells. AGT's approach is unique in that it focuses on repairing the key immune system damage caused by HIV. When HIV infection causes this specific damage, killing of T helper cells required for immunity to HIV, the infected person becomes unable to eliminate the virus and thus, becomes chronically infected. AGT's approach is designed to repair the T helper cell defect and provide durable virus control that is not compromised by HIV strains that vary in sequence or use alternate ways to enter and infect T cells. AGT's AGT103-T HIV therapeutic drug should work to remove infected cells from the body and decrease or eliminate the need for lifelong antiretroviral treatment. About American Gene Technologies American Gene Technologies (AGT) is a clinical-stage cell and gene therapy company focusing on treatments and cures for viral infections, acquired or inherited diseases, and cancer. Operating in Rockville, MD, AGT designs, develops, and tests novel genetic medicines using a gene-delivery platform that accelerates early-stage testing and enables rapid translation to the clinic. The company has an extensive patent portfolio covering gene therapies for HIV disease, Phenylketonuria (PKU), and solid tumor forms of epithelial cancer. For more information on AGT's Phase 1 clinical trial, visit clinicaltrials.gov (Study Identifier: NCT04561258). Media Contacts: Sasha Whitaker, Digital Marketing and Communications Phone: (301) 337-2100 Email: swhitaker@americangene.com C. Neil Lyons, Chief Financial Officer Phone: (301) 337-2100 Email: info@americangene.com