Curatis Receives IND Approval for Clinical Phase 2b and 3 Trials of 'QTP101' Tuberculosis Vaccine for Adolescents and Adults

Exterior view of Curatis Osong Bioplant.

[Asia Economy Reporter Lee Gwan-joo] Curatis announced on the 26th that it has received approval from the Ministry of Food and Drug Safety for the multinational Phase 2b/3 clinical trial plan (IND) of 'QTP101,' a tuberculosis vaccine under development for adolescents and adults.

Curatis confirmed the excellent tolerability and safety of QTP101 in the first domestic Phase 2a clinical trial on adults and Phase 1 clinical trial on adolescents. It also demonstrated strong immunogenicity compared to placebo and maintained it continuously.

The QTP101 tuberculosis vaccine consists of tuberculosis antigens and synthetic immune adjuvants. The tuberculosis antigens are recombinant fusion protein antigens created using genetic recombination technology from four pathogenic and latent proteins derived from Mycobacterium tuberculosis. The immune adjuvant helps enhance vaccine efficacy and enables sufficient immunity even with a small amount of antigen.

This Phase 2b/3 late-stage clinical trial will consecutively conduct the Phase 3 clinical trial based on the interim analysis results of Phase 2b (Stage 1). At the baseline of both stages, the efficacy, immunogenicity, and safety of the QTP101 tuberculosis vaccine will be evaluated in adolescents and adults with positive and negative or positive results in the latent tuberculosis infection test (QFT).

The Phase 2b clinical trial will be conducted at Yonsei University Severance Hospital, Ajou University Hospital, Chung-Ang University Hospital, and Hallym University Chuncheon Sacred Heart Hospital. The Phase 3 clinical trial will recruit participants competitively in Southeast Asia (Indonesia, the Philippines, Thailand, Vietnam, etc.) including South Korea. The target number of enrolled subjects is 240 for Phase 2b and 7,461 for Phase 3, totaling 7,701.

Curatis aims to file for the world's first marketing authorization for an adolescent and adult tuberculosis vaccine in the second half of 2025. Choi Yoo-hwa, Executive Director of Curatis, who oversees the clinical trials, said, “Building on the approval of this Phase 3-level clinical trial plan, we aim to demonstrate superior tuberculosis protection, long-term immunogenicity, and safety when QTP101 tuberculosis vaccine is administered as an additional dose compared to the existing BCG vaccination. We intend to solidify its position as the world's first commercialized next-generation tuberculosis vaccine, secure the global competitiveness of 'K-Bio,' and ultimately lay the foundation to contribute to the eradication of tuberculosis infectious diseases.”

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