Uvax Bio Initiates Phase 1 Trial for HIV-1 Vaccine Candidates

Uvax Bio, LLC, a clinical-stage vaccine company specializing in advanced computational biology, has commenced a Phase 1 clinical trial in Australia for its HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197. This study involves dosing the first healthy volunteers to assess the safety and immunogenicity of these novel protein nanoparticle vaccines.

Uvax Bio CEO, Ji Li, Ph.D., highlighted the urgent need for an effective HIV-1 vaccine, given that approximately 1.3 million people are newly infected with HIV each year. Dr. Li emphasized the innovative design and delivery of the UVAX-1107 and UVAX-1197 vaccines, marking a significant step in HIV vaccine development.

The clinical trial, identified as ACTRN12624000064505, involves 34 healthy adult volunteers who match the study's criteria. It aims to evaluate the safety and immune response of UVAX-1107 and UVAX-1197 following initial and booster doses. The study will explore whether either vaccine, or a combination, yields the best immunological results. The results are expected to be released in late 2024.

Both UVAX-1107 and UVAX-1197 are developed using Uvax Bio’s 1c-SApNP® platform, displaying 20 copies of the prefusion-stabilized HIV-1 envelope trimer. These innovative vaccines are intended for active immunization to prevent HIV-1 infection.

Preclinical studies of UVAX-1107 and UVAX-1197 combined with an adjuvant indicated safety and no serious adverse events, aligning with previously approved protein-based vaccines. An additional immunogenicity study showed that these vaccines elicit robust neutralizing antibody responses against the targeted virus in 99% of test animals. Serum tests indicated effective neutralization of various HIV-1 strains.

Details of UVAX-1107 and UVAX-1197

Utilizing the 1c-SApNP® technology, UVAX-1107 and UVAX-1197 present 20 uncleaved, prefusion-optimized HIV envelope trimers in wild-type and glycan-trimmed forms. UVAX-1197 maintains the virus' native glycan shield, while UVAX-1107 undergoes glycan trimming (GT) to expose neutralizing epitopes on the HIV-1 envelope. This GT strategy was recognized by IUPAC as a top emerging technology in chemistry for 2023, highlighting its innovative approach in vaccine development.

HIV/AIDS Overview

The global impact of HIV/AIDS remains significant, with the Joint United Nations Programme on HIV/AIDS noting 39 million people living with HIV and 1.3 million new infections in 2022. In the U.S., the CDC estimated 32,100 new HIV infections in 2021. HIV requires ongoing antiviral treatment to prevent progression to AIDS, as there is currently no cure.

About Uvax Bio

Uvax Bio, a spin-off from Scripps Research, leverages the 1c-SApNP® platform to develop vaccines for pressing infectious diseases. Founded on technology created by Dr. Jiang Zhu from Scripps Research, Uvax Bio holds exclusive rights to this platform, advancing both clinical and preclinical vaccine candidates. Besides HIV, the company is developing vaccines for influenza, RSV, and hMPV. Their technology facilitates the production of virus-like protein particles capable of displaying multiple stabilized antigens, produced via a streamlined cell-based process.

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