EXP03-INF: Engineered EV Platform for Multivalent Infectious-Disease Vaccines

EXORPHIA is a biotechnology company with an integrated platform for extracellular vesicle (EV) manufacturing, purification, engineering, and quality control. Next-generation IVF technologies are our core business, while therapeutic assets are advanced through external partnering, co-development, and licensing.

EXP03-INF is an engineered EV platform for multivalent infectious-disease vaccines. The technology enables antigen/protein cargos to be displayed on the EV surface and/or loaded into the EV lumen, allowing multiple antigens to be incorporated into a single EV design.

Current nonclinical proof-of-concept primarily supports multivalent EV vaccine applications.

In mouse studies:

• Low-dose, dual-antigen EVs induced antibody responses to both antigens and antigen-specific T-cell responses.

• Antigen-loaded EVs containing 0.01 μg of antigen induced antibody responses in the same study that included a 1 μg inactivated whole-virus comparator.

• An early seroconversion signal was observed by approximately Day 8, and antibody responses were monitored through approximately Day 180.

• Intradermal priming followed by intranasal boosting induced mucosal IgA responses.

• Under the evaluated single-dose intramuscular study conditions, no apparent body-weight loss, fever, or inflammatory cytokine induction was observed, providing an exploratory tolerability signal in mice.

The platform may be adapted to partner-selected antigens and infectious-disease targets, including seasonal, respiratory, and emerging pathogens. Target selection, antigen combinations, administration route, and target product profile would be defined with the partner.

EXORPHIA’s platform includes EV production, purification, antigen/protein-loading technology, analytical characterization, and a CMC/QC foundation. The applicable intellectual-property portfolio includes granted patents in Japan and the United States and a pending multi-antigen EV vaccine application.

We are seeking an exclusive license partner to further develop and commercialize EXP03-INF in selected infectious-disease applications.

EXORPHIA would provide the platform overview, nonclinical PoC package, access to the applicable proprietary EV technology, and CMC/QC foundation. Following licensing, the partner would lead antigen and TPP selection, IND-enabling studies, regulatory development, clinical development, manufacturing scale-up, and commercialization.