The UVAX-1107 protein nanoparticle vaccine was safe and well-tolerated in healthy volunteers at the planned Interim Analysis #1
The planned Interim Analysis #1 was performed after two priming doses of UVAX-1107, out of the planned two priming vaccinations with UVAX-1107 followed by two booster vaccinations with UVAX-1107/UVAX-1197
A planned immunogenicity analysis showed robust vaccine-matched IgG antibody responses in 100% of subjects after receiving two priming doses of UVAX-1107
NEWARK, DE, USA I November 19, 2024 I Uvax Bio, LLC, (“Uvax” or “the Company”) a privately held, clinical-stage vaccine company utilizing rational design principles to deliver novel protein-based nanoparticle vaccines, today announced the results of the interim analysis from their first Phase 1 clinical trial evaluating the Company’s HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197, in healthy volunteers in Australia.
In the first stage of this trial, the subjects received either UVAX-1107 adjuvanted with CpG 1018® (Dynavax) and aluminum hydroxide or placebo. UVAX-1107 utilizes Uvax Bio’s 1c-SApNP® vaccine development platform to generate virus-like particles (VLPs) which closely resemble the target virus in size, shape, and multivalent antigen display; in this case, 20 copies of the native-like, prefusion-stabilized trimeric HIV-1 antigen.
Safe and Well Tolerated
“We are pleased that our first Phase 1 trial is progressing smoothly, and we have preliminary confirmation that UVAX-1107 was well tolerated at all doses by the study participants, and no vaccine-related serious adverse events were reported,” said Pedro Garbes, M.D., Vice President and Global Clinical Lead of Uvax Bio. “As per the time of this 1st interim analysis, no participant was withdrawn from the study due to local/systemic reactogenicity; local and systemic adverse events were mild to moderate, transient, and they resolved on average within two days. These preliminary safety results are aligned with expectations for an adjuvanted protein-based vaccine.”
Early Immune Responses
UVAX-1107 was immunogenic and generated robust IgG responses to the vaccine antigen derived from an HIV-1 strain known as BG505. 100% of subjects in the vaccine group demonstrated antibody responses after two priming vaccinations with UVAX-1107. Antibody response titers increased >200-fold 14 days after the 2nd dose as compared to the same period following the first dose.
About the Uvax Bio HIV-101 Phase 1 HIV-1 Vaccine Trial
The first-in-human clinical trial UVAX-HIV-101 (ClinicalTrials.gov ID NCT06541093) is evaluating two different regimens of the UVAX-1107 and UVAX-1197 vaccines in 34 healthy adult volunteers who meet the study eligibility criteria. The primary endpoints of the study will measure safety and immunogenicity of UVAX-1107 and UVAX-1197 after the priming and boosting dose series being evaluated in parallel arms. The study will also investigate whether either vaccine or the combination of both produces the optimal immunological response. Uvax Bio expects to report topline data from a 2nd interim analysis after the first booster vaccination (out of two boosters with UVAX-1107/UVAX-1197/Placebo) for the Phase 1 trial in the first quarter of 2025.
The need for an HIV Vaccine
There is a tremendous unmet need for a vaccine to help protect against HIV-1 infection.
The Joint United Nations Programme on HIV/AIDS estimates that 39 million people worldwide are currently living with HIV. According to the World Health Organization (WHO), an estimated 1.3 million people worldwide become infected with HIV annually. Globally, 9.2 million people living with HIV are not receiving treatment. The majority of new infections come from undiagnosed or undertreated HIV patients (WHO/CDC).
About UVAX-1107 and UVAX-1197
The UVAX-1197 HIV-1 vaccine was designed and produced based on Uvax Bio’s proprietary 1c-SApNP® technology. These vaccines employ two innovative technologies. This first is the unique antigen design of the uncleaved prefusion-optimized (UFO) HIV-1 envelope (Env) trimers. The second is the self-assembled, multi-layered protein nanoparticle which displays 20 copies of the UFO trimer in a symmetrical manner. UVAX-1107 employs a third advanced technology called “glycan-trimming” to remove a portion of the glycan shield to allow better access to the conserved neutralizing epitopes on HIV-1 Env. This third technology 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’s laboratory at Scripps Research in La Jolla, CA (https://www.scripps.edu/faculty/zhu/).
About Uvax Bio
Uvax Bio, LLC, a spin-off vaccine company from Scripps Research, employs proprietary 1c-SApNP® platform technology invented by Scripps researchers to develop and commercialize vaccines for challenging infectious diseases. The 1c-SApNP® platform utilizes the latest advances in computational and structural biology to design and produce complex protein structures (VLPs) that closely resemble the target virus in its infectious form. These intricately designed VLPs activate and prolong interaction with the immune system, which is expected to generate more potent and durable immune responses compared to soluble protein vaccines.
Uvax Bio holds exclusive worldwide rights to the 1c-SApNP® platform and an expanding portfolio of 12 patented vaccine candidates in development at stages ranging from optimization to clinical development. In addition to the leading clinical candidates for HIV-1, Uvax Bio is working to advance its vaccine candidates for influenza, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and hepatitis C virus (HCV). Uvax Bio vaccines are produced using a single-step, universal, cell-based manufacturing process. For more information, visit www.uvaxbio.com.
UVAX HIV-101 Phase 1 Clinical Study
Clinical Trials.gov
https://clinicaltrials.gov/study/NCT06541093?term=NCT06541093&rank=1
SOURCE: Uvax Bio
Post Views: 89
The UVAX-1107 protein nanoparticle vaccine was safe and well-tolerated in healthy volunteers at the planned Interim Analysis #1
The planned Interim Analysis #1 was performed after two priming doses of UVAX-1107, out of the planned two priming vaccinations with UVAX-1107 followed by two booster vaccinations with UVAX-1107/UVAX-1197
A planned immunogenicity analysis showed robust vaccine-matched IgG antibody responses in 100% of subjects after receiving two priming doses of UVAX-1107
NEWARK, DE, USA I November 19, 2024 I Uvax Bio, LLC, (“Uvax” or “the Company”) a privately held, clinical-stage vaccine company utilizing rational design principles to deliver novel protein-based nanoparticle vaccines, today announced the results of the interim analysis from their first Phase 1 clinical trial evaluating the Company’s HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197, in healthy volunteers in Australia.
In the first stage of this trial, the subjects received either UVAX-1107 adjuvanted with CpG 1018® (Dynavax) and aluminum hydroxide or placebo. UVAX-1107 utilizes Uvax Bio’s 1c-SApNP® vaccine development platform to generate virus-like particles (VLPs) which closely resemble the target virus in size, shape, and multivalent antigen display; in this case, 20 copies of the native-like, prefusion-stabilized trimeric HIV-1 antigen.
Safe and Well Tolerated
“We are pleased that our first Phase 1 trial is progressing smoothly, and we have preliminary confirmation that UVAX-1107 was well tolerated at all doses by the study participants, and no vaccine-related serious adverse events were reported,” said Pedro Garbes, M.D., Vice President and Global Clinical Lead of Uvax Bio. “As per the time of this 1st interim analysis, no participant was withdrawn from the study due to local/systemic reactogenicity; local and systemic adverse events were mild to moderate, transient, and they resolved on average within two days. These preliminary safety results are aligned with expectations for an adjuvanted protein-based vaccine.”
Early Immune Responses
UVAX-1107 was immunogenic and generated robust IgG responses to the vaccine antigen derived from an HIV-1 strain known as BG505. 100% of subjects in the vaccine group demonstrated antibody responses after two priming vaccinations with UVAX-1107. Antibody response titers increased >200-fold 14 days after the 2nd dose as compared to the same period following the first dose.
About the Uvax Bio HIV-101 Phase 1 HIV-1 Vaccine Trial
The first-in-human clinical trial UVAX-HIV-101 (ClinicalTrials.gov ID NCT06541093) is evaluating two different regimens of the UVAX-1107 and UVAX-1197 vaccines in 34 healthy adult volunteers who meet the study eligibility criteria. The primary endpoints of the study will measure safety and immunogenicity of UVAX-1107 and UVAX-1197 after the priming and boosting dose series being evaluated in parallel arms. The study will also investigate whether either vaccine or the combination of both produces the optimal immunological response. Uvax Bio expects to report topline data from a 2nd interim analysis after the first booster vaccination (out of two boosters with UVAX-1107/UVAX-1197/Placebo) for the Phase 1 trial in the first quarter of 2025.
The need for an HIV Vaccine
There is a tremendous unmet need for a vaccine to help protect against HIV-1 infection.
The Joint United Nations Programme on HIV/AIDS estimates that 39 million people worldwide are currently living with HIV. According to the World Health Organization (WHO), an estimated 1.3 million people worldwide become infected with HIV annually. Globally, 9.2 million people living with HIV are not receiving treatment. The majority of new infections come from undiagnosed or undertreated HIV patients (WHO/CDC).
About UVAX-1107 and UVAX-1197
The UVAX-1197 HIV-1 vaccine was designed and produced based on Uvax Bio’s proprietary 1c-SApNP® technology. These vaccines employ two innovative technologies. This first is the unique antigen design of the uncleaved prefusion-optimized (UFO) HIV-1 envelope (Env) trimers. The second is the self-assembled, multi-layered protein nanoparticle which displays 20 copies of the UFO trimer in a symmetrical manner. UVAX-1107 employs a third advanced technology called “glycan-trimming” to remove a portion of the glycan shield to allow better access to the conserved neutralizing epitopes on HIV-1 Env. This third technology 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’s laboratory at Scripps Research in La Jolla, CA (https://www.scripps.edu/faculty/zhu/).
About Uvax Bio
Uvax Bio, LLC, a spin-off vaccine company from Scripps Research, employs proprietary 1c-SApNP® platform technology invented by Scripps researchers to develop and commercialize vaccines for challenging infectious diseases. The 1c-SApNP® platform utilizes the latest advances in computational and structural biology to design and produce complex protein structures (VLPs) that closely resemble the target virus in its infectious form. These intricately designed VLPs activate and prolong interaction with the immune system, which is expected to generate more potent and durable immune responses compared to soluble protein vaccines.
Uvax Bio holds exclusive worldwide rights to the 1c-SApNP® platform and an expanding portfolio of 12 patented vaccine candidates in development at stages ranging from optimization to clinical development. In addition to the leading clinical candidates for HIV-1, Uvax Bio is working to advance its vaccine candidates for influenza, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and hepatitis C virus (HCV). Uvax Bio vaccines are produced using a single-step, universal, cell-based manufacturing process. For more information, visit www.uvaxbio.com.
UVAX HIV-101 Phase 1 Clinical Study
Clinical Trials.gov
https://clinicaltrials.gov/study/NCT06541093?term=NCT06541093&rank=1
SOURCE: Uvax Bio
Post Views: 89
