VT Bio, FDA Approves Clinical Trial for Alzheimer's Treatment Using Regulatory T Cells

[Asia Economy Reporter Jang Hyowon] VT GMP affiliate VT Bio announced that its 'antigen-specific autoregulatory T cell (VT301S) Alzheimer's disease clinical trial' was finally approved by the U.S. FDA Center for Biologics Evaluation and Research (CBER) on the 23rd.

This U.S. clinical trial is the second Alzheimer's disease treatment clinical trial using regulatory T cells conducted worldwide, following Korea. Phase 1 and Phase 2a clinical trials were approved simultaneously, and the freezing conditions, the biggest hurdle for cell therapy products, were secured. The code name is VT301S. VT301, which lacks freezing conditions, is already undergoing Phase 1 clinical trials at Seoul National University Hospital, where safety and pharmacokinetic characteristics are being confirmed and the trial is nearing completion.

VT301S is an antigen-specific immunoregulatory cell with a mechanism of action differentiated from antibody therapeutics based on the beta-amyloid hypothesis. Alzheimer's disease is theorized to be caused by complex factors, ultimately resulting from immune imbalance due to excessive immune activation in the brain, and it is expected that regulating this aspect could lead to improvement in Alzheimer's disease. Specifically, VT301S aims to improve microglia, the brain's immune cells.

A VT Bio official explained, "We plan to conduct the U.S. clinical trial within this year, and we are in the process of selecting hospitals to conduct the clinical trial, with some selections already completed."

Although the approval of Biogen's Aduhelm has increased the likelihood of success for Alzheimer's disease treatments, the efficacy and adverse reactions of the treatments remain controversial. However, it is a field with very high unmet medical needs, and the market size is significantly increasing due to aging populations in each country. The global market research firm MARC estimated the worldwide market size in 2020 to be $6.34 billion (approximately 7.8533 trillion KRW), with an expected compound annual growth rate of 6.5% from last year through 2026.

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