Cleo SG Achieves Optimization of AIDS Vaccine Production for US FDA Phase 2 Clinical Trial

CreoSG announced on the 15th that it has successfully completed the production test of clinical phase 2 samples for the world’s first AIDS vaccine, ‘SAV001-H,’ approved by the U.S. Food and Drug Administration (FDA). CreoSG plans to accelerate the development of SAV001-H by simultaneously conducting clinical sample production and preclinical trial procedures.

Earlier this year, CreoSG signed a contract with the global contract development and manufacturing organization (CDMO) ‘Naobios’ for the production of SAV001-H clinical samples. Under the contract, CreoSG transferred the technology for its own production process, and Naobios successfully applied CreoSG’s cultivation method to its facilities and further succeeded in discovering optimized conditions.

SAV001-H is a killed vaccine that uses the entire structure of HIV (human immunodeficiency virus) inactivated as an antigen, which is effective in inducing neutralizing antibodies. AIDS is currently incurable and the number of patients is steadily increasing, but there has been no global case of AIDS vaccine development to date. Because AIDS mutates very rapidly, it is important to induce neutralizing antibodies against variant strains and to identify which viral structures induce neutralizing antibodies.

Since HIV itself poses a risk, a high level of biological safety must be maintained. SAV001-H is characterized by attenuating HIV based on genetic recombination technology and undergoing two inactivation processes, making it not only safe but also minimizing the impact on the vaccine antigen. The company explained that since it has already obtained FDA agreement on the phase 2 synopsis through a ‘Type C meeting,’ it will be able to quickly enter full-scale clinical procedures after mass production.

To accelerate the development of SAV001-H, CreoSG is concurrently conducting various procedures along with sample production. Recently, it signed a consulting agreement with local experts to proceed with the U.S. phase 2 clinical trial and is preparing the phase 2 IND (Investigational New Drug application) with the global contract research organization (CRO) ‘Fortrea.’ To expand the AIDS vaccine pipeline, it is also developing a combination vaccine based on its proprietary universal vaccine development platform ‘SUV-MAP.’ CreoSG is conducting animal experiments at Western University in Canada to evaluate the efficacy of the combination vaccine.

A CreoSG official stated, “Based on CreoSG’s production process design capabilities and Naobios’s virus cultivation technology, we successfully conducted tests for HIV production,” and emphasized, “In addition to HIV sample production, we are accelerating preclinical preparations related to clinical trials to speed up the commercialization of the world’s first AIDS vaccine.”

He added, “SAV001-H has already shown a significant increase in antibody levels up to 512-fold during phase 1 clinical trials, maintained for 12 months, and confirmed the formation of neutralizing antibodies against various mutations, attracting high interest from global pharmaceutical companies,” and said, “We plan to promote global technology transfer after successfully completing the FDA phase 2 clinical trial.”