VT BIO’s VT301, Autologous Regulatory T cells (‘Tregs’) for Alzheimer’s
VT BIO’s VT301, Autologous Regulatory T cells (‘Tregs’) for Alzheimer’s
  • Hyun Duk Yang
  • 승인 2021.11.21 08:42
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VT301 reduces neuroinflammation
Undergoing phase 1 and 2 clinical trials 

Repeated failures with treatment trials based on amyloid and tau hypothesis have made researchers’ interest turn to other strategies such as cell replacement or immune regulation.

The accumulation of misfolded proteins like beta-amyloid and tau triggers microglial activation and leads to neuronal inflammation and degeneration. 

The regulatory T cells (Tregs) control the inflammatory response of activated immune cells, reduce neuroinflammation, and thereby protect neurons in the brain, which have been evidenced in the preclinical studies. Therapeutic approaches aimed at enhancing the functions of Tregs can be one of various treatment options for Alzheimer’s disease (AD).

VT301 (also known as GB301) is a novel investigational drug (suspension of autologous Tregs) developed by VT BIO, headquartered in Seoul, a biotechnology company developing cell therapies for neurodegenerative diseases like AD, Parkinson’s disease, and amyotrophic lateral sclerosis.

To develop VT301, VT BIO used its proprietary platform technology (Therapeutic Treg Enhancer, named ‘TTE01’) that isolates Alzheimer-specific (CD4+ and CD25+) Tregs and allows large-scale production.

In the AD mouse models, VT301 have shown to promote the clearance of beta-amyloid and reverse cognitive dysfunction.

VT BIO initiated its phase 1 study in South Korea in December 2020, scheduled to be completed in April 2022. In parallel with this, the company is also conducting its phase1/2 clinical trial in Australia which is expected to be completed in December 2021, in conjunction with BHT Lifescience Austrailia Pty Ltd. Furthermore, the company is planning to enter into phase 1 and 2a in the U.S. soon.

Clinical Trials

A Phase 1 Open-Label Dose-Escalating Study to Determine the Safety, and Tolerability of VT301 in Subjects with Mild-to-Moderate Alzheimer's Disease
ClinicalTrials.gov Identifier: NCT05016427

A Safety and Tolerability Study of GB301 Given as a Single Intravenous Dose in Subjects with Mild to Moderate Alzheimer's Disease (Phase 1/ 2)
ClinicalTrials.gov Identifier: NCT03865017

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