Novel HIV-1 Protein Nanoparticle Vaccine Candidates Launch Research in Australia

Uvax Bio, LLC today announced acknowledgment from the Australian Therapeutic Goods Administration and approval from the Human Research Ethics Committee (HREC) to conduct a Phase 1 study of Uvax Bio's HIV-1 vaccine candidates in Australia.

The two vaccines being tested are based on Uvax Bio's proprietary 1c-SApNP® technology, displaying 20 uncleaved, prefusion-optimized (UFO) HIV envelope (Env) trimers in wild-type and glycan-trimmed forms (UVAX-1197 and UVAX-1107, respectively).

Uvax Bio's HIV-1 vaccines are combined with Dynavax's CpG 1018® adjuvant and aluminum hydroxide.

Uvax Bio will work with their Australia-based clinical research partners Avance Clinical and the Nucleus Network study site to initiate this study in January 2024.

Previously, in a preclinical toxicology study, UVAX-1107 & 1197 combined with CpG 1018® and aluminum hydroxide were safe with no serious adverse events.

In a second preclinical immunogenicity study, immunization with Uvax Bio's HIV-1 vaccine candidates elicited robust neutralizing antibody responses against the vaccine-matched virus in 99% of the animals.

Furthermore, preliminary screening assays demonstrated appreciable neutralization in serum when tested against a panel of primary HIV-1 isolates.

"The body of evidence from our preclinical studies and GMP manufacturing runs was instrumental in facilitating this authorization to begin preparation for our first Phase 1 trial," commented Ji Li, Ph.D., Uvax Bio CEO, in a press release on December 19, 2023.

"Our clinical team will begin preparing to initiate this trial in January 2024."

As of December 20, 2023, the U.S. Food and Drug Administration, Japan's National Institute of Infectious Diseases, the European Medicines Agency, and the United Kingdom had not approved an HIV prevention vaccine.