On October 21, 2025, Inovio announced that results from a Phase 1 proof‑of‑concept trial evaluating DNA‑encoded monoclonal antibodies (DMAbs) for COVID‑19 were published online in Nature Medicine. The study, titled “Safety and pharmacokinetics of SARS‑CoV‑2 DNA‑encoded monoclonal antibodies in healthy adults: a phase 1 trial,” was released by the company and the journal on the same day.
The open‑label, single‑center, dose‑escalation trial enrolled 39 healthy adults between May 2022 and March 2024. All participants received intramuscular injections of synthetic DNA plasmids encoding AZD5396 and AZD8076 delivered via Inovio’s CELLECTRA 2000 electroporation device. The trial demonstrated that 100 % of evaluable participants maintained biologically relevant levels of the DMAbs through 72 weeks of follow‑up, with peak serum concentrations of 1.61 µg/mL.
Importantly, no participant developed anti‑drug antibodies and the DMAbs successfully bound to the SARS‑CoV‑2 spike protein and neutralized pseudovirus in all tested subjects. The safety profile was favorable, with only mild, temporary injection‑site reactions reported and three serious adverse events deemed unrelated to the study product. These findings support the breakthrough potential of DMAbs as a long‑acting, scalable, and tolerable alternative to conventional monoclonal antibody therapies.
The publication marks a significant operational milestone for Inovio’s DNA medicines platform, providing the first human evidence of durable in‑vivo antibody production and reinforcing the company’s strategy to expand its pipeline beyond infectious disease into broader therapeutic areas.
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