CreoSG confirms 512-fold antibody production in US AIDS vaccine trial... Rising hopes for emergency use authorization

It is reported that an AIDS vaccine developed by a subsidiary of CreoESG (formerly Qurocom) showed an increase in antibodies by up to 512 times in a Phase 1 clinical trial in the United States.

According to industry sources on the 22nd, the AIDS vaccine 'SAV001' developed by CreoESG's subsidiary ImmunoVaxBio demonstrated a significant production of antibodies that were maintained over a long period and formed neutralizing antibodies against various variants in the U.S. Phase 1 clinical trial.

Neutralizing antibodies are a key indicator for evaluating vaccine efficacy. Since SAV001 confirmed effectiveness against variant viruses, which is one of the challenges in developing AIDS vaccines, it is analyzed that there is a high possibility of emergency use authorization after the completion of Phase 2 clinical trials.

ImmunoVaxBio confirmed that in the U.S. Phase 1 clinical trial, most subjects administered SAV001 showed an increase in antibodies by up to 512 times, which was maintained for 12 months. HIV carriers typically have poor antibody production, making them vulnerable to infection and progression to AIDS. While Phase 1 trials usually evaluate only the safety of the drug, efficacy evaluation was also conducted simultaneously due to the high mutation rate characteristic of HIV, which causes AIDS.

SAV001 formed neutralizing antibodies against various HIV variant viruses. The U.S. Phase 1 clinical trial of SAV001 was conducted on HIV subtype B-infected individuals in North America. After administration of SAV001, neutralizing antibody responses were confirmed not only for subtype B but also for HIV subtypes A and D.

Neutralizing antibodies are antibodies that neutralize viruses invading the human body. When an antigen enters the body, neutralizing antibodies bind to the antigen to prevent cell infection. This is called the neutralization reaction, and vaccines form the immune system through this neutralization reaction.

A company official stated, "Neutralizing antibodies are a key indicator for evaluating the infection prevention effect of vaccines during the vaccine development process, and the research results on the neutralizing antibody production of SAV001 have been published in international journals." He added, "Based on the excellent AIDS prevention effect of SAV001, we plan to apply for emergency use authorization (EUA) after the U.S. Phase 2 clinical trial, and if EUA is obtained, supply can begin in countries with high AIDS incidence."

Although global pharmaceutical companies are developing AIDS vaccines, no commercialized vaccine exists yet. HIV not only destroys the immune system but also exists in thousands of variants within the body, making vaccine development difficult. Most pharmaceutical companies have developed AIDS vaccines by injecting fragmented parts of HIV into the body to induce an immune response.

ImmunoVaxBio is developing a vaccine by completely inactivating the entire HIV virus and administering it into the body for the first time in the world. Using the whole virus as a vaccine maintains immunity even if HIV mutates.

A company official emphasized, "Making a vaccine by inactivating the entire virus requires high technology and the sample production process and requirements are also demanding." He added, "Since we are developing an AIDS vaccine using a new method, not the method that other pharmaceutical companies have failed with, we expect to succeed in commercializing the world's first AIDS vaccine."