- Uvax Bio-owned vaccines demonstrated significant improvement in immune response compared with current vaccine strategies
- Phase 1 clinical trial sponsored by National Institutes of Health expected to commence in 2024
NEWARK, Del., April 26, 2023 (GLOBE NEWSWIRE) -- Uvax Bio, LLC, a privately held, preclinical-stage vaccine company, today 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.
About HIV/AIDS
The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that 38.4 million people worldwide are currently living with HIV, and 1.5 million people became newly infected with HIV in 2021 alone. According to the latest estimates from the Centers for Disease Control and Prevention (CDC), approximately 34,800 new HIV infections occurred in the United States in 2019. Apart from very rare cases involving bone marrow transplants, there is no cure for the infection, which must be held in check indefinitely with antiviral drugs to keep it from progressing to the deadly immune deficiency condition known as AIDS.
About Uvax Bio
Uvax Bio, a spin-off vaccine company from Scripps Research, employs proprietary 1c-SApNP® platform technology invented by Dr. Jiang Zhu of Scripps Research to develop and commercialize prophylactic vaccines for challenging infectious diseases. Uvax Bio holds the exclusive worldwide rights to the 1c-SApNP® platform and an expanding portfolio of 12 patented preclinical vaccine candidates. In addition to the leading candidates in HIV, Uvax is also working to advance its vaccines for Universal Flu and RSV. The company’s technology enables the production of virus-like protein particles that can display 20-60 stabilized antigens targeting a wide range of viral and bacterial diseases. The vaccines are produced using a single step, universal, cell-based manufacturing process.
For more information, visit www.uvaxbio.com.
Contact
Kevin O’Neill
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302-595-2285
