Quratis' novel TB vaccine confirms safety, immunogenicity in phase 2 study
22 May 2023 -- Quratis said on Monday that the phase 2a clinical trial results of its novel tuberculosis (TB) vaccine for adults and adolescents, QTP101, showed excellent safety and immunogenicity.
The phase 2a trial was conducted on 107 healthy adults with a history of Bacillus Calmette–Guérin (BCG) immunization at Severance Hospital, Chung-Ang University Hospital, and Ajou University Hospital.
Accordingly, the QTP101 TB vaccine group demonstrated clinically and statistically significant increases in antigen-specific antibody levels and Type 1 T-helper cell immune responses compared to the control group. Furthermore, the study showed that immune responses were sustained for 12 months.
Regarding safety, no serious adverse events or deaths leading to treatment discontinuation were reported and the drug was clinically well-tolerated.
Based on the results, Quratis submitted an investigational new drug (IND) plan to the Ministry of Food and Drug Safety (MFDS) for a multi-country phase 2b/3 serialized clinical trial of the QTP101 TB vaccine and received approval for the clinical trial plan in July of last year.
The phase 2b/3 clinical trial aims to demonstrate long-term safety and evaluate immunogenicity and efficacy in a large cohort of healthy adolescents and adults.
"This publication recognizes the excellent safety and immunogenicity of our QTP101 TB vaccine," said Quratis’ Managing Director Choi Yu-hwa, who led the clinical trial. "We are in the final stages of clinical development, and if we are successful in commercializing our TB vaccine for adolescents and adults, we will be able to enter the market as a leader."
Choi added that the multi-country phase 2b/3 late-stage clinical trials will enable the company to be the first in the world to commercialize and compete with next-generation TB vaccines, to help end TB globally.
Based on the Global TB Report 2022 published by the World Health Organization (WHO), approximately 10.6 million people contracted TB in 2021, a 4.5 percent increase from 2020. The annual number of TB deaths has been declining since 2005 but has been on the rise, increasing from 1.4 million in 2019 to 1.5 million in 2020, further increasing 14 percent to 1.6 million in 2021, marking the second consecutive year of growth.
According to WHO, the global value of new TB vaccines is estimated at $37.2 billion for adolescent and adult vaccines.
The results of the study were published in the Infectious Diseases and Therapy journal.
Source: Korea Biomedical Review
