CreoSG Signs Contract to Produce Samples for World’s First AIDS Vaccine Phase 2 Clinical Trial with US FDA

Creo ESG (formerly known as Qurocom) announced on the 16th that its subsidiary ImmunoVaxBio (formerly known as Smagen) has signed a clinical sample production contract with the global pharmaceutical contract development and manufacturing organization (CDMO) Naobios for the Phase 2 clinical trial of the AIDS vaccine ‘SAV001’ in the United States. SAV001 is the world’s first attempted ‘whole inactivated AIDS vaccine,’ characterized by using the entire virus as an antigen, resulting in excellent preventive effects against AIDS.

Naobios, the company contracted this time, is a bioprocess development and clinical trial vaccine production specialist headquartered in France. Equipped with its own Biosafety Level 3 (BSL3) production facility, it can produce vaccines for high-risk viruses such as AIDS. Naobios specializes in the bioprocess field based on expert personnel capable of handling various viruses and cell substrates.

Through this contract, Naobios will oversee the vaccine manufacturing process used in the Phase 2 clinical trial of the AIDS vaccine being developed by ImmunoVaxBio in the United States. After receiving technology related to the existing production process from ImmunoVaxBio, Naobios will produce AIDS vaccine samples that meet cGMP (current Good Manufacturing Practice) standards through simple additional process development and optimization.

Eric Forestier, Head of Research at Naobios, stated, “It is meaningful to contribute to the commercialization of the AIDS vaccine through the production of SAV001, the world’s first AIDS vaccine developed by ImmunoVaxBio,” and emphasized, “Based on Naobios’ accumulated virus and vaccine production technology, we will successfully complete the production of samples for the SAV001 Phase 2 clinical trial.”

ImmunoVaxBio is developing the world’s first AIDS vaccine. Having completed the U.S. Phase 1 clinical trial and obtained agreement on the Phase 2 synopsis through a Type C meeting with the U.S. Food and Drug Administration (FDA), it is expected to quickly enter the full clinical process after vaccine production.

A company official said, “Producing large quantities of HIV (Human Immunodeficiency Virus) in vitro requires sophisticated technology and production facilities that meet high safety standards, making sample production a bottleneck in the AIDS vaccine development process,” adding, “It has been difficult to find a company with both production facilities and technological capabilities, but we will continue close collaboration with Naobios, which possesses differentiated know-how related to BSL3 facilities and clinical trial samples, to accelerate the development of the world’s first AIDS vaccine.”

He continued, “Since trial production was already conducted during the development of the large-scale production process after the completion of the U.S. Phase 1 clinical trial, we expect to complete sample production quickly,” and added, “We will focus the company’s full capabilities on the goal of commercializing the world’s first AIDS vaccine.”

This content was produced with the assistance of AI translation services.