In January 2024 Uvax announced that the first participant in a Phase I clinical trial to evaluate the company’s HIV-1 vaccine candidates has been dosed. The first-in-human clinical trial will evaluate two different regimens of UVAX-1107 and UVAX-1197 in 34 healthy volunteers in Australia. UVAX reports that the primary endpoints will measure safety and immunogenicity after the primary and boosting dose series being evaluated in parallel arms. It will also assess whether either vaccine, or a combination of both, produces the “optimal immunological response”.
UVAX vaccines in trial
UVAX-1107 and UVAX-1197 are based on the company’s proprietary 1c-SApNP® technology, displaying 20 uncleaved, prefusion-optimised (UFO) HIV envelop (Env) trimers in glycan-trimmed and wild-type forms, respectively. UVAX-1107 has a portion of the glycan shield through glycan trimming, an enzymatic removal of glycans to allow better access to the conserved neutralising epitopes. By comparison, UVAX-1197 retains the wild-type glycan shield.
In a preclinical toxicology study, both vaccines were shown to be safe with no serious adverse events and consistent with previously approved protein-based vaccines. A second preclinical study demonstrated that they “elicited robust neutralising antibody responses against the vaccine-matched virus in 99% of the animals”. Preliminary screening assays also demonstrated “appreciable neutralisation” in serum when tested against a panel of primary HIV-1 isolates.
Meeting an unmet need
Dr Ji Li, CEO of Uvax, commented on the “tremendous unmet need” for a vaccine to protect against HIV-1 infection.
“UVAX-1107 and UVAX-1197 represent an advancement in HIV vaccine technology with industry-recognised innovations in our design and delivery and delivery.”
Dr Li is “proud” of the team for bringing these “promising” vaccine candidates into human testing, which is a “significant milestone”.
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