Chabaksin Research Institute Voluntarily Withdraws Application for Phase 1 Clinical Trial of Shingles Vaccine... "Plans to Reapply"

[Asia Economy Reporter Chunhee Lee] Cha Vaccine Institute has voluntarily withdrawn its application for Phase 1 clinical trial of the recombinant protein shingles vaccine candidate ‘CVI-VZV-001’ under development. The company announced on the 21st that it plans to reapply for the Investigational New Drug (IND) application within the first half of the year.

Previously, in August last year, Cha Vaccine Institute submitted the Phase 1 clinical trial IND for the shingles vaccine to the Ministry of Food and Drug Safety. Subsequently, the Ministry requested additional data to supplement some experimental results from the characterization analysis of the cell bank, and Cha Vaccine Institute commissioned SGS Vitrology, a global clinical trial contract research organization (CRO) based in the UK, to conduct the analysis.

However, due to increased workload caused by the COVID-19 pandemic and difficulties in procuring raw materials necessary for the analysis tests, the schedule of the analysis institution was delayed by 2 to 3 months. Judging that it would be difficult to submit the final report by the deadline set by the Ministry, Cha Vaccine Institute decided to withdraw the existing IND application and reapply.

Yeom Jeong-seon, CEO of Cha Vaccine Institute, said, “This voluntary withdrawal of the IND application is a temporary issue caused by the COVID-19 situation,” and added, “We will reapply for the Phase 1 clinical trial IND as soon as the related data is secured within the first half of this year to ensure that there is no disruption to the pipeline development schedule.”