An In-Depth Analysis of the HIV-1 Vaccine Candidate UVAX-1197

I. Executive Summary

UVAX-1197 is an investigational prophylactic vaccine candidate engineered to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. Developed by Uvax Bio, LLC, a clinical-stage biotechnology company, UVAX-1197 is based on a sophisticated single-component self-assembling protein nanoparticle (1c-SApNP®) platform. This platform is designed to display multiple copies (20 in this case) of a stabilized, uncleaved prefusion-optimized (UFO) version of the HIV-1 envelope (Env) trimer derived from the BG505 viral strain. A distinguishing characteristic of UVAX-1197 is its presentation of the Env trimer with its native, wild-type glycan shield intact.

Currently, UVAX-1197 is undergoing evaluation in a Phase 1 clinical trial (designated UVAX-HIV-101, with identifiers NCT06541093 and ACTRN12624000064505) in healthy adult volunteers in Australia. This trial is assessing the safety and immunogenicity of UVAX-1197 in various regimens, including its use as a booster following priming doses of a related candidate, UVAX-1107, which features a glycan-trimmed Env trimer.

Preclinical studies conducted in multiple animal models have indicated a favorable safety profile for vaccine constructs similar to UVAX-1197 and have demonstrated the capacity to elicit robust humoral immune responses. The nanoparticle presentation format has shown advantages over soluble protein antigens in terms of enhanced lymph node retention and germinal center activation, which are critical for the development of strong and durable immunity. Interim data from the Phase 1 clinical trial, primarily focusing on the UVAX-1107 priming component, have reported good safety and tolerability, alongside encouraging immunogenicity with 100% of vaccinated participants demonstrating antibody responses.