NEWARK, DE — Uvax Bio, LLC this week announced that its HIV vaccine candidates have shown significant improvement in immune response compared with current vaccine strategies, according to results from preclinical studies described in a paper published in Nature Communications titled, “Single-component multilayered self-assembling protein nanoparticles presenting glycan-trimmed uncleaved prefusion optimized envelope trimers as HIV-1 vaccine candidates.”
Based on these results, the National Institutes of Health (NIH) has agreed to sponsor a Phase 1 clinical trial in healthy volunteers which is expected to launch in the first quarter of 2024.
“With this design we appear to have solved a big piece of the HIV vaccine puzzle,” said Jiang Zhu, Ph.D., senior author of the study, associate professor in the Department of Integrative Structural and Computational Biology at Scripps Research, and Co-Founder of Uvax Bio.
The single-component self-assembling protein nanoparticle (1c-SApNP®) platform vaccine technology and the lead HIV vaccine candidates utilized in the studies have been exclusively licensed to Uvax Bio under a comprehensive agreement with Scripps Research.
The novel vaccine design uses tiny protein “nanoparticles” to display multiple copies of HIV’s envelope glycoprotein (Env), mimicking HIV particles and inducing a strong immune response in hosts without causing HIV infection. The key innovation can be attributed to flexible sugar molecules called glycans, which normally cover Env on the real virus but are shortened in the new design allowing the antigens to be further exposed to the human immune system to induce functional antibodies.
“Dr. Zhu and his team at Scripps Research have made tremendous innovations in HIV vaccine design that we believe have the potential to improve outcomes in patients,” said Ji Li, Ph.D., Chief Executive Officer of Uvax Bio.
Uvax Bio is currently conducting two final preclinical studies in preparation for the submission of an Investigational New Drug (IND) application. GMP lot manufacturing was completed earlier this year on the two vaccine candidates which will be used in the Phase 1 clinical trial. Stability testing is underway with two months of stability at standard refrigeration and under accelerated conditions reported to date.
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