Quratis, Korea's First Adult Tuberculosis Vaccine Application

Korea ranked No. 1 in tuberculosis mortality among OECD countries...Adult Tuberculosis vaccine absence

Quratis has completed a clinical application with the Food and Drug Administration to develop a vaccine against tuberculosis for adults for the first time in Korea.

Quratis held a press conference at the Presidential Hotel in Euljiro, Jung-gu, Seoul, on Thursday and announced that it applied for the second clinical award on Friday to localize a vaccine for adult tuberculosis.

"There is a BCG vaccine for all infants within four weeks of birth in Korea to prevent tuberculosis, but no vaccine against adults at a time when it is not effective is allowed," said Cho Kwan-gu, CEO of Quratis.

"While the government is doing well in the field of newborns through various vaccine prevention activities, adults die six to seven people a day," Cho said, stressing the importance of vaccines against tuberculosis in adults.

This two-phase clinician evaluates safety and efficacy with the aim of inducing tuberculosis defense immunity in three doses to adults aged 19 or older. If the development is successful, 37 million adults aged 18 to 70 or older in Korea are subject to inoculation. The annual increase from less than 1 percent of all adults is expected to increase gradually to 10 percent four years after its launch, Quratis predicted.

According to data released by Quratis at the meeting, Korea has 30,000 new TB cases every year and 2,200 people die from tuberculosis. It ranks No. 1 in TB cases, prevalence, mortality and multidrug-resistant tuberculosis among OECD countries.

Head of Quratis Research Institute, said, "We expect the vaccine to be effective every 10 years," expecting the vaccine to prevent tuberculosis in adults over the age of 18.

The new TB-preventive vaccine, named ID93, consists of three pathotoxic antigens of tuberculosis bacteria, one antigen related to latent infection and a TLR4 action-based synthetic immunosuppressant called GLA-SE, a platform technology that enhances the immune response.

"In some cases, tuberculosis hides for decades," Cho said. "Because we selected and fused the protein antigens by analyzing the bioinformatics of tuberculosis bacteria around the world, we have strengthened our effectiveness while maintaining safety and purity, which is the strength of subunit vaccines."

"The reason why it is difficult to develop vaccines for adults is that they need long-term research and facilities above the level of BSL (Bio Safety Level) 3 or higher," he said. "The Yonsei Medical Center invested 10 billion won to set up research facilities." Quratis is a spin-off venture at a joint medical center and signed a contract with IDRI, a non-profit medical institution in the U.S., last year to develop vaccine technology for adults.

Cho expected to receive the clinical 2b award in 2019 and end both the IDRI's global third and domestic clinical trials in 2024.