CreoSG "AIDS Vaccine... Clinical Phase 2 Preparation in Full Swing"

CreoSG announced on the 28th that it has signed a consulting agreement with local experts to officially commence the Phase 2 clinical trial of the world's first AIDS vaccine, ‘SAV001-H,’ with the U.S. Food and Drug Administration (FDA), and has begun related discussions. CreoSG plans to collaborate with Dr. Onesmo Mpanju, an expert in CMC (Chemistry, Manufacturing, and Controls) and clinical approval regulations, to initiate the Phase 2 clinical trial of SAV001-H in the United States.

Dr. Mpanju is a virology and clinical regulatory expert with over 25 years of experience, having been responsible for the approval review of gene therapies at the FDA’s Center for Biologics Evaluation and Research (CBER). He has also provided consulting services related to CMC and clinical approval regulations for global pharmaceutical companies in China, the UK, and other countries through multinational CROs (Contract Research Organizations).

Under this agreement, CreoSG will proceed with the CMC procedures for SAV001-H together with Dr. Mpanju. Dr. Mpanju plans to review FDA guidelines related to the production of vaccine samples for Phase 2 clinical trials and derive data packages that comply with regulations. They will also collaborate on further development of the clinical sample production process required for FDA Phase 2 clinical trial approval.

Since SAV001-H is the world’s first attempt at a ‘whole inactivated AIDS vaccine,’ the company explained that this consulting contract will ensure smooth preparation for clinical trials in the U.S. CreoSG has previously conducted Phase 1 clinical trials of SAV001-H on HIV (Human Immunodeficiency Virus) carriers at four hospitals in California. The clinical trial results showed no toxicity or side effects and confirmed the induction of antibodies capable of preventing AIDS. By using the entire virus as an antigen, it is expected to maximize the therapeutic and preventive effects against AIDS.

Earlier this year, CreoSG signed a material production contract with the global pharmaceutical CDMO (Contract Development and Manufacturing Organization) company ‘Nau Bios’ and is accelerating preparations for the FDA Phase 2 clinical trial. Nau Bios specializes in bioprocess development and vaccine production for clinical trials. The two companies have entered the final stage of feasibility review through virus cultivation.

A CreoSG official stated, “As large-scale sample production for the Phase 2 clinical trial of SAV001-H is now underway, we have resumed cooperation with Dr. Mpanju to prepare for the clinical trial,” adding, “During the FDA Phase 1 clinical trial, we closely collaborated with Dr. Mpanju on IND (Investigational New Drug) submission, Type C meetings, and process development, so preparations for the AIDS vaccine Phase 2 trial will proceed smoothly.”

He continued, “SAV001-H is an AIDS vaccine attracting global attention as it demonstrated safety in Phase 1, with a significant increase and long-term maintenance of antibodies, as well as the formation of neutralizing antibodies against various variants. In addition to the AIDS vaccine, we plan to discuss strategies for entering the U.S. FDA market for various vaccine candidates based on SUV-MAP by leveraging Dr. Mpanju’s FDA experience and regulatory knowledge,” he added.