EuBiologics' second factory (V Plant) in Chuncheon. [EuBiologics]
EuBiologics' second factory (V Plant) in Chuncheon. [EuBiologics]

Vaccine specialist EuBiologics said Tuesday it has filed an investigational new drug application with the Ministry of Food and Drug Safety for a Phase 1 clinical trial of Padivax, its Alzheimer's disease treatment vaccine candidate.

Padivax is a peptide-based therapeutic vaccine that simultaneously targets amyloid beta and tau — the two proteins widely regarded as central to the development of Alzheimer's disease. Unlike conventional antibody therapies that rely on continuous infusions of externally produced antibodies, Padivax works through an active immunity mechanism, stimulating the body's own immune response to generate antibodies against both proteins.

The candidate incorporates two of EuBiologics' proprietary platform technologies: EuIMT, a TLR4 agonist-based immune-enhancement technology, and SNAP, an antigen display technology. In preclinical studies, the company confirmed antigen-specific antibody production against both amyloid beta and tau, and demonstrated cognitive improvement and safety in Alzheimer's mouse model experiments.

The Phase 1 trial will mark the first human administration of Padivax and will enroll patients with mild cognitive impairment or early-stage Alzheimer's disease. Following regulatory approval, participants will be enrolled in low-, medium- and high-dose cohorts and randomly assigned alongside a placebo group. The trial calls for five doses administered at four-week intervals, with long-term safety, tolerability and immunogenicity — including antibody formation — tracked and assessed throughout.

The move marks a significant expansion of EuBiologics' research and development scope, extending beyond its traditional focus on infectious disease prevention vaccines into therapeutic vaccines for hard-to-treat neurodegenerative conditions such as Alzheimer's disease, where unmet medical need remains high. It also broadens the application of the company's proprietary immune-enhancement platform to innovative new drug development.

"Padivax is a pipeline we have developed carefully, verifying efficacy and safety step by step, as it represents a challenge in the entirely new territory of Alzheimer's treatment vaccines," a company official said. "Through this first-in-human clinical trial, we will rigorously confirm its safety and demonstrate the potential of a therapeutic vaccine that simultaneously targets amyloid beta and tau."


silverpaper@heraldcorp.com