Uvax Bio Announces Dosing of First Participant in Phase 1 Clinical Trial Evaluating Two Vaccines to Prevent HIV-1 Infection

Study to assess safety and immunogenicity of novel protein nanoparticle vaccine candidates UVAX-1107 and UVAX-1197 in healthy volunteers

NEWARK, Del.–(BUSINESS WIRE)–Uvax Bio, LLC, (“Uvax” or “the Company”) a privately held, clinical-stage vaccine company utilizing rational and computational biology to design and deliver novel 1c-SApNP^® protein-based vaccines, today announced the first participant has been dosed in a Phase 1 clinical trial evaluating the Company’s HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197, in healthy volunteers in Australia.

“With an estimated 1.3 million people worldwide becoming infected with HIV annually, there is a tremendous unmet need for a vaccine to help protect against HIV-1 infection,” said Ji Li, Ph.D., Uvax Bio CEO. “UVAX-1107 and UVAX-1197 represent an advancement in HIV vaccine technology with industry-recognized innovations in our antigen design and delivery. I am proud of the Uvax Bio team for bringing our promising HIV-1 vaccine candidates into human testing, a significant milestone for the Company.”

The first-in-human clinical trial (ACTRN12624000064505) is evaluating two different regimens of the UVAX-1107 and UVAX-1197 vaccines in 34 healthy volunteer adults who meet the study inclusion criteria. The primary endpoints of the study will measure safety and immunogenicity of UVAX-1107 and UVAX-1197 after the primary and boosting dose series being evaluated in parallel arms. The study will also determine whether either vaccine or the combination of both produces the optimal immunological response. Uvax Bio expects to report topline data from the Phase 1 trial in the fourth quarter of 2024.

UVAX-1107 and UVAX-1197 utilize Uvax Bio’s 1c-SApNP^® platform displaying 20 copies of the native-like, prefusion-stabilized HIV-1 envelope (Env) trimer based on the uncleaved, prefusion-optimized (UFO) design. The novel protein nanoparticle vaccine candidates are designed for active immunization and are intended to prevent HIV-1 infection.

In a preclinical toxicology study, UVAX-1107 and UVAX-1197 combined with adjuvant was shown to be safe with no serious adverse events, consistent with previously approved protein-based vaccines. Additionally, a second preclinical immunogenicity study demonstrated immunization with UVAX-1107 and UVAX-1197 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.

About UVAX-1107 and UVAX-1197

UVAX-1197 and UVAX-1107 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). The two antigens differ insofar as UVAX-1197 retains the virus’ wild-type glycan shield, while UVAX-1107 has a portion of the glycan shield removed through glycan trimming (GT). GT is an enzymatic removal of glycans to allow better access to the conserved neutralizing epitopes on HIV-1 Env. This innovative GT strategy was recognized by the International Union of Pure and Applied Chemistry (IUPAC) – who dubbed it “low-sugar vaccination” – as one of the Top Ten Emerging Technologies in Chemistry for 2023. The UFO trimer, 1c-SApNP platform, and glycan trimming strategy were developed by Dr. Jiang Zhu, Associate Professor, Department of Integrative Structural and Computational Biology at Scripps Research in La Jolla, CA.

About HIV/AIDS

The Joint United Nations Programme on HIV/AIDS estimates that 39 million people worldwide are currently living with HIV, and 1.3 million people became newly infected with HIV in 2022 alone. According to the latest estimates from the Centers for Disease Control and Prevention, there were 32,100 estimated new HIV infections in the U.S. and the rate was 11.5 (per 100,000 people) in 2021. Apart from very rare cases involving bone marrow transplants, there is no cure for HIV, 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, LLC, a spin-off vaccine company from Scripps Research, employs proprietary 1c-SApNP^® platform technology invented by Jiang Zhu, Ph.D., of Scripps Research to develop and commercialize prophylactic vaccines for challenging infectious diseases. Uvax Bio holds exclusive worldwide rights to the 1c-SApNP^® platform and an expanding portfolio of two clinical and 10 patented preclinical vaccine candidates. In addition to the leading clinical candidates in HIV, Uvax Bio is working to advance its vaccines for influenza, RSV and hMPV. 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.

Contacts

Kevin O’Neill

SVP, Corporate Strategy

info@uvaxbio.com
302-595-2285