VT Bio "VT301 Alzheimer's Treatment Demonstrates Therapeutic Effect"

VT Bio, a subsidiary of VT, announced on the 12th that VT301 (antigen-specific regulatory T cells), which has completed Phase 1 clinical trials in Korea, showed groundbreaking reductions in beta-amyloid concentration and tau phosphorylation, as well as improvements in various inflammation markers, in the 5xFAD mouse model, a representative animal model of dementia.

In a previously published paper, the efficacy of VT301 was confirmed in another representative animal model of dementia, the 3xTg mouse model. Currently, VT301 has received FDA approval in the United States for Phase 1/2a clinical trials and is in the preparation stage for these trials.

VT Bio and the Kyung Hee University research team confirmed sufficient potential for regulatory T cell therapy for degenerative brain diseases through experiments. To deliver cells to the affected brain, they developed a method to culture antigen-specific regulatory T cells using amyloid beta as the antigen and completed process setting at a GMP facility.

Based on this culturing technology, VT301 was administered to the 5xFAD animal model of Alzheimer's disease, and memory-related behavioral tests such as the Y-maze test and passive avoidance test (PAT) were conducted, confirming improvements in learning and memory similar to those of normal mice. Additionally, during clinical trials, it was confirmed that the accumulation of representative dementia biomarkers, beta-amyloid and phosphorylated tau (p-Tau), improved to levels comparable to normal animal models.

VT Bio has submitted the results derived from the Phase 1 clinical trial to a Q1-level international journal specializing in degenerative brain diseases, ranked in the top 25% of academic journals, and the paper is currently under additional review, with promising results expected soon. Furthermore, based on the domestic clinical trial, the cell injection dose and timing for VT301 can be predicted. VT Bio has completed a confidentiality agreement with a specialized cell therapy hospital in Japan and is conducting VT301 culturing there to perform cell equivalency testing. Related approvals are planned to be applied for in the first half of this year, with rapid approval processes underway, and services are planned to be provided in Japan, where there is a large elderly population.

Recently, in Korea, the amendment to the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act (ARMA) has passed the relevant subcommittee, raising expectations for service implementation in Korea. The existing clinical trials in the United States have already been approved, and preparations for clinical trials are underway through close consultations with related clinical research organizations (CROs).

This content was produced with the assistance of AI translation services.