Cleo SG Makes Progress in Developing World's First AIDS Vaccine... "US FDA Phase 2 Clinical Trials Underway"

CreoESG (formerly Qurocom) announced on the 11th that the research and development of the AIDS vaccine ‘SAV001,’ being developed by its subsidiary ImmunoVaxBio (formerly Smagen), is progressing smoothly. ImmunoVaxBio has completed most of the preliminary procedures related to the Phase 2 clinical trial of the AIDS vaccine and plans to apply for the Phase 2 clinical trial plan (IND) with the FDA after large-scale vaccine sample production.

SAV001, developed by ImmunoVaxBio, is the world’s only ‘whole inactivated AIDS vaccine’ capable of both treating and preventing AIDS. Because it uses the entire virus as an antigen, it has excellent preventive effects, but the technical difficulty and the approval standards of the U.S. FDA are high. AIDS is a high-risk pathogen, and vaccine production is only possible in facilities that meet strict standards.

In particular, Phase 2 clinical trials require more stringent FDA approval procedures regarding the quality of production samples and analytical methods than Phase 1. ImmunoVaxBio completed Phase 1 clinical trials in 2017 and finished discussions with the FDA regarding subsequent development processes; however, the production of AIDS vaccine samples was halted as contract manufacturers shifted to producing COVID-19 vaccines following the outbreak of COVID-19. ImmunoVaxBio plans to proceed with full-scale AIDS vaccine development after completing the preparation procedures for producing vaccine samples for Phase 2 clinical trials.

ImmunoVaxBio has already verified the efficacy and safety of the SAV001 vaccine in the U.S. Phase 1 clinical trial. During the clinical process, it was confirmed that neutralizing antibodies, which play an important role in preventing AIDS, were formed in the body. Both chemical and radiation treatments were applied, and no side effects were observed. Since the company established a mass production process for the vaccine and obtained FDA approval after conducting Phase 1, it explained that it would be able to enter Phase 2 clinical trials quickly.

A company official stated, “Although AIDS vaccine development was delayed due to COVID-19, we have accelerated securing clinical vaccine sample production facilities after the endemic phase, and preparations are entering the final stage. SAV001’s advantage is its excellent preventive effect as a whole inactivated AIDS vaccine, unlike existing AIDS vaccines that use only parts of the human immunodeficiency virus (HIV).”

Although the number of AIDS patients worldwide continues to increase, there is still no commercialized AIDS vaccine. According to the global market research firm 360iResearch LLP, the global AIDS vaccine market size is expected to grow from $677.83 million (approximately 1 trillion KRW) last year at an average annual growth rate of 40%, reaching $7.01184 billion (approximately 9.6 trillion KRW) by 2030. According to the WHO (World Health Organization), the number of AIDS-infected patients worldwide was about 39 million as of 2022.