VT Bio, VT301 Clinical Trial Progressing Smoothly... "Expected to Complete Within the Year"

[Asia Economy Reporter Jang Hyowon] VT GMP affiliate VT Bio announced on the 6th that the Phase 1 clinical trial of VT301 currently underway at Seoul National University Hospital is progressing as planned.

A VT Bio official stated that the domestic Phase 1 clinical trial is expected to be completed in the second half of the year, and based on the results, the next phase of clinical trials will be conducted within the first half of 2023.

VT Bio recently received clinical trial approval from the FDA CBER for the frozen version of VT301 in the United States as well. In particular, the cell freezing technology, which is scheduled to be patented in the second half of this year, is based on results produced by VT Bio through the operation of its own laboratory (LMO Level 2).

VT Bio's VT301 is a cell therapy that extracts regulatory T cells from the body, improves them into antigen-specific regulatory T cells, and re-administers them into the body. Cell therapies generally use living cells.

Therefore, cell therapies face significant constraints in terms of distance and time, and to overcome these hurdles, a freezing process is applied. However, a problem that arises during this freezing process is that cells may be damaged or die. Know-how regarding these conditions can ultimately be a major variable in the commercialization of cell therapies.

VT Bio has conducted research on cryoprotectants for VT301 since the establishment of its laboratory and has data on a wide variety of conditions. Cryoprotectants must be non-toxic when the cell therapy is finally administered to patients, and recently, VT Bio secured cryoprotectant conditions that meet these requirements. Based on this, the company plans to file a new international patent in the second half of the year, according to a VT Bio official.

In fact, VT Bio received approval including this cryoprotectant when applying for clinical trials in the United States, and is also conducting research to overcome the cultivation limits of VT301. Additionally, a VT Bio official stated, “Based on the developed technologies and achievements, we intend to approach various degenerative diseases caused by immune imbalance, including final autoimmune diseases, as a platform technology.”

Meanwhile, the clinical trial VT Bio is conducting domestically is in the stage where the last patient administration remains.