CreOsg Reports Smooth Progress in Phase 2 Clinical Sample Production for AIDS Vaccine 'SAV001'

CreOsg reported on the preparation status for Phase 2 clinical trials and the progress in large-scale manufacturing technology development for 'SAV001,' the world's first whole inactivated AIDS vaccine, which is being developed through its Bio Division and its subsidiary, Sumagen Canada.

CreOsg successfully completed Phase 1 clinical trials of the world's first whole inactivated HIV vaccine. The company began GMP production for Phase 2 but had to temporarily halt development due to the COVID-19 pandemic. At that time, BioMARC, the U.S. institution responsible for production, was requisitioned under a U.S. government executive order, resulting in a suspension of production. Subsequently, CreOsg sought a new partner and, in 2024, signed a clinical sample production agreement with Naobios, a global pharmaceutical contract manufacturing organization (CMO) based in France.

Through this partnership, Naobios successfully transferred Sumagen's accumulated production technology and conducted small-scale cell and virus culture experiments. This led to the signing of a full-scale production contract. The companies then gradually expanded production, establishing a process for culturing over 50 liters, which is the GMP sample production scale. They are currently in the final optimization stage of the purification process to increase production yield.

The collaboration between Sumagen Canada and Naobios was featured in the March issue of the global bio journal BioProcess International. The article highlighted the technical and academic originality of SAV001, the successful Phase 1 clinical trial, and the joint efforts of both companies to establish a large-scale manufacturing system.

CreOsg is systematically preparing to begin clinical trials as soon as GMP production for Phase 2 is completed. The company has already coordinated its Phase 2 clinical trial plans with the U.S. FDA through a Type C meeting.

Phase 2 clinical trials are designed to maximize the preventive and therapeutic effects of SAV001 based on Phase 1 results. The trials will focus on high-risk groups, such as men who have sex with men, to verify the difference in efficacy between single and repeated doses. The vaccine's therapeutic effect for HIV-infected patients will also be evaluated separately.

To this end, CreOsg has signed a contract with the global clinical research organization (CRO) Fortrea (formerly Covance) and has already completed the clinical trial protocol and IND (Investigational New Drug) application, as well as plans for conducting the clinical trial. Fortrea has been involved in the SAV001 project since preparations for the Type C meeting and will continue to collaborate not only for Phase 2 clinical trials in the United States and Canada but also for later Phase 2 and Phase 3 global clinical stages.

A CreOsg representative stated, "SAV001 is the world's first whole inactivated AIDS vaccine, and since it requires the safe in vitro culture of large quantities of HIV virus, advanced technology and specialized facilities are essential." The representative added, "Although there were several technical challenges, close cooperation with Naobios has enabled smooth production of clinical samples for Phase 2 trials," and continued, "We have made thorough preparations to begin Phase 2 clinical trials as soon as sample production is complete."