Uvaxbio

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 .

NEWARK, Del.--( BUSINESS WIRE )-- Uvax Bio, LLC , a privately held, clinical-stage vaccine company, today announced acknowledgement from Australian Therapeutic Goods Administration and approval from the Human Research Ethics Committee (HREC) to conduct a Phase 1 study of Uvax Bio's HIV-1 vaccine candidates in healthy volunteers in Australia. Uvax Bio will work with their Australia-based clinical research partners Avance Clinical and the Nucleus Network study site to initiate this study in January 2024. The two vaccines being tested 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). Uvax Bio’s HIV-1 vaccines are combined with CpG 1018 ® adjuvant and aluminum hydroxide. In a preclinical toxicology study, UVAX-1107 & 1197 combined with CpG 1018 ® and aluminum hydroxide were shown to be safe with no serious adverse events. These results are consistent with previously approved protein-based vaccines. In a second preclinical immunogenicity study, immunization with Uvax Bio’s HIV-1 vaccine candidates 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. “The body of evidence from our preclinical studies and GMP manufacturing runs was instrumental in facilitating this authorization to begin preparation for our first Phase 1 trial,” commented Ji Li, Ph.D., Uvax Bio CEO. “Our clinical team will immediately begin the preparation to initiate this trial in January 2024.” About the Phase I Clinical Trial The study will investigate the safety of two different regimens of UVAX-1107 and UVAX-1197 vaccines. Both vaccines utilize Uvax Bio’s 1c-SApNP ® platform displaying 20 copies of the native-like, prefusion-stabilized HIV- 1 envelope (Env) trimer based on the UFO design. The two antigens differ insofar as UVAX-1197 retains the virus’ “wildtype” (WT) glycan shield, while UVAX-1107 has a portion of the glycan shield removed through “glycan trimming” (GT). Glycan trimming is an enzymatic removal of glycans to allow better access to the conserved neutralizing epitopes on HIV-1 Env. The vaccine candidates are designed for active immunization and are intended to prevent HIV-1 infection. The Uvax Bio HIV-1 vaccines will be administered to 34 healthy adult subjects that meet the study inclusion criteria. The primary endpoints will measure the safety, reactogenicity, and immunogenicity of the Uvax Bio HIV-1 vaccines after the primary and boosting dose series. The study will investigate whether either vaccine or the combination of both produces the optimal immunological response. 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, LLC , a spin-off vaccine company from Scripps Research, employs proprietary 1c-SA p NP® 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 Bio is also 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 .

Dr. Jiang Zhu of Scripps Research participating as a featured speaker. Additional data on Uvax Bio HIV-1 to be presented in poster form. NEWARK, Del.--(BUSINESS WIRE)-- Uvax Bio, LLC, a privately held, preclinical-stage vaccine development company, today announced that Dr. Jiang Zhu, Associate Professor of Integrative Structural and Computational Biology at Scripps Research, and Co-founder of Uvax Bio, LLC will be presenting a review of the development of Uvax Bio’s HIV-1 vaccine candidates including the latest results from the company’s preclinical studies confirming safety and immunogenicity in rodent models. The presentation will be during the World Vaccine Congress – West Coast in Santa Clara, California on November 30th. Dr. Zhu invented the UFO HIV antigen trimer and utilized his single-component self-assembling protein nanoparticle (1c-SApNP®) vaccine platform technology to produce the two vaccines that were used in the preclinical program. Zhu added the innovative step to further modify his vaccine with a process called glycan trimming which demonstrated enhanced immune responses in the studies. The glycan trimming approach – referred to as “low-sugar vaccination” - was recently named one of IUPAC’s Top Ten Emerging Technologies in Chemistry. The 1c-SApNP platform technology and HIV-1 vaccine candidates have been exclusively licensed to Uvax Bio under a comprehensive agreement with Scripps Research. Animal Studies Show High Response Rates and Broad Neutralization In a recent preclinical immunogenicity study in rats, Uvax Bio tested its HIV-1 vaccines (UVAX-1107 and UVAX-1197) in different regimens, each combined with CpG 1018® adjuvant (Dynavax Technologies Corporation) and Alhydrogel® (Croda). Overall, immunization with Uvax’s HIV-1 vaccines elicited robust autologous tier 2 neutralization, with >93% showing positive neutralization. Furthermore, preliminary neutralization screening against a 12-virus panel of heterologous tier 2 HIV-1 pseudoviruses shows that 54 out of 72 rats tested thus far (75%) showed ≥ 50% neutralization against at least one non-vaccine-matched pseudovirus. “Our preclinical studies have confirmed both the safety and robust immunogenicity of our vaccine candidates for HIV-1. These data combined with our completed GMP manufacturing of the vaccine supplies were the final steps in our preparation for human trials,” said Ji Li, Ph.D., Chief Executive Officer of Uvax Bio. 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 to prevent life-threatening infectious diseases. The vaccines in development by Uvax Bio present a virus-sized protein nanoparticle with many copies of the antigen in its pre-fusion state. Animal studies have confirmed robust levels of broadly neutralizing antibodies in multiple disease states. Uvax Bio holds the exclusive worldwide rights to the 1c-SApNP® platform and an expanding portfolio of 12 patented preclinical optimized vaccine candidates. In addition to the leading candidates in HIV-1, Uvax is also working to advance universal influenza and RSV/hMPV vaccines. The 1c-SApNP technology enables the production of virus-like protein particles that can display 20-60 pre-fusion 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 on Uvax Bio, visit .