Baizensel "Voluntary Withdrawal of Phase 1 Clinical Trial for Glioblastoma Treatment"

[Asia Economy Reporter Myunghwan Lee] VigenCell announced on the 9th that it has decided to voluntarily withdraw its application for clinical trial approval from the Ministry of Food and Drug Safety for the glioblastoma treatment 'VT-Tri(2)-G.'

VT-Tri(2)-G, which VigenCell decided to voluntarily withdraw, is a treatment for glioblastoma. It was submitted for clinical trial approval (IND) for Phase 1 clinical trials in May last year to develop a tumor treatment that overcomes immune evasion mechanisms using multiple antigens.

VigenCell stated that the decision to voluntarily withdraw the clinical trial approval application was made after receiving a request from the Ministry of Food and Drug Safety to supplement some of the non-clinical trial data, and judging that it would be difficult to submit the requested non-clinical trial data within the supplementation period.

VigenCell explained that considering the additional research time and costs required to meet the new requirements following the enactment of the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act, which raised regulations to a global level, it judged that it is possible to approach a more improved new treatment and thus made this decision.

A VigenCell official said, "Chimeric Antigen Receptor (CAR)-T has shown good research results in hematologic cancers, but cases of effectiveness in solid tumors are rare," and added, "We plan to closely analyze the failure cases of CAR-T therapies targeting solid tumors and present follow-up research results at upcoming global conferences."

Kim Taegyu, CEO of VigenCell, said, "We decided to voluntarily withdraw VT-Tri(2)-G to efficiently allocate resources and time in the fiercely competitive immuno-oncology development market," and added, "We will focus on research and development of CAR-T and further TCR-T therapies, which are global new drug development trends, to develop innovative immune cell therapies."