The purpose of this Phase IIa study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule of T-lymphocytes and monocytes, is safe and effective when multiple doses are administered by intravenous infusion to asymptomatic HIV-1 infected adults and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.

Start Date01 Sep 2012

Sponsor / Collaborator

United Biomedical, Inc.

[+2]

100 Clinical Results associated with United Biomedical, Inc. Asia

0 Patents (Medical) associated with United Biomedical, Inc. Asia

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17 Oct 2022·The Journal of Infectious Diseases

High Neutralizing Antibody Levels Against Severe Acute Respiratory Syndrome Coronavirus 2 Omicron BA.1 and BA.2 After UB-612 Vaccine Booster

Article

Author: Wang, Shixia ; Rumyantsev, Alexander ; Hunt, Adam ; Monath, Thomas P ; Hu, Mei Mei ; Wang, Chang Yi ; Wang, Lixia ; Kuo, Hui Kai ; Peng, Wen Jiun ; Johnson, Marina ; Guirakhoo, Farshad ; Goldblatt, David ; Liu, Hope

AbstractThe highly transmissible severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant has caused high rates of breakthrough infections in those previously vaccinated with ancestral strain coronavirus disease 2019 (COVID-19) vaccines. Here, we demonstrate that a booster dose of UB-612 vaccine candidate delivered 7–9 months after primary vaccination increased neutralizing antibody levels by 131-, 61-, and 49-fold against ancestral SARS-CoV-2 and the Omicron BA.1 and BA.2 variants, respectively. Based on the receptor-binding domain protein binding antibody responses, the UB-612 third-dose booster may lead to an estimated approximately 95% efficacy against symptomatic COVID-19 caused by the ancestral strain. Our results support UB-612 as a potential potent booster against current and emerging SARS-CoV-2 variants.

medRxiv

UB-612, a multitope universal vaccine eliciting a balanced B and T cell immunity against SARS-CoV-2 variants of concern

Author: Peng, Wen-Jiun ; Chang, Po-Yen ; Chiu, Han-Chen ; Wang, Min-Sheng ; Liu, Hope ; Hwang, Kao-Pin ; Shen, Yea-Huei ; Hou, Kuo-Liang ; Ho, Yu-Hsin ; Kuo, Be-Sheng ; Kuo, Hui-Kai ; Yang, Ya-Ting ; Cheng, Jennifer ; Wang, Chang Yi ; Tsai, Wan-Yu

The SARS-CoV-2 non-spike structural proteins of nucleocapsid (N), membrane (M) and envelope (E) are critical in the host cell interferon response and memory T-cell immunity and have been grossly overlooked in the development of COVID vaccines.To determine the safety and immunogenicity of UB-612, a multitope vaccine containing S1-RBD-sFc protein and rationally-designed promiscuous peptides representing sequence-conserved Th and CTL epitopes on the Sarbecovirus nucleocapsid (N), membrane (M) and spike (S2) proteins.UB-612 booster vaccination was conducted in Taiwan.A UB-612 booster dose was administered 6-8 mo post-2^nd dose in 1,478 vaccinees from 3,844 healthy participants (aged 18-85 years) who completed a prior placebo (saline)-controlled, randomized, observer-blind, multi-center Phase-2 primary 2-dose series (100-μg per dose; 28-day apart) of UB-612.The interim safety and immunogenicity were evaluated until 14 days post-booster.Vaccination with a booster 3^rd-dose (100-μg) of UB-612 vaccine.Solicited local and systemic AEs were recorded for seven days in the e-diaries of study participants, while skin allergic reactions were recorded for fourteen days.The primary immunogenicity endpoints included viral-neutralizing antibodies against live SARS-CoV-2 wild-type (WT, Wuhan strain) and live Delta variant (VNT₅₀), and against pseudovirus WT and Omicron variant (pVNT₅₀).The secondary immunogenicity endpoints included anti-S1-RBD IgG antibody, S1-RBD:ACE2 binding inhibition, and T-cell responses by ELISpot and Intracellular Staining.No post-booster vaccine-related serious adverse events were recorded.The most common solicited adverse events were injection site pain and fatigue, mostly mild and transient.The UB-612 booster prompted a striking upsurge of neutralizing antibodies against live WT Wuhan strain (VNT₅₀, 1,711) associated with unusually high cross-neutralization against Delta variant (VNT₅₀, 1,282); and similarly with a strong effect against pseudovirus WT (pVNT₅₀, 6,245) and Omicron variant (pVNT₅₀, 1,196).Upon boosting, the lower VNT₅₀ and pVNT₅₀ titers of the elderly in the primary series were uplifted to the same levels as those of the young adults.The UB-612 also induced robust, durable VoC antigen-specific Th1-oriented (IFN-γ+-) responses along with CD8+ T-cell (CD107a+-Granzyme B+) cytotoxicity.With a pronounced cross-reactive booster effect on B- and T-cell immunity, UB-612 may serve as a universal vaccine booster for comprehensive immunity enhancement against emergent VoCs.

Potent Anti-Delta Effect By a Booster Third-Dose of UB-612, a Precision-Designed SARS-CoV-2 Multitope Protein-Peptide Vaccine

Author: Chiu, Han Chen ; Heppner, Donald ; Chang, Po-Yen ; Yu, Hui-Jiing ; Chen, Sky ; Hu, Mei Mei ; Jiang, Ming-Han ; Guirakhoo, Farshad ; Lin, Yi-Ling ; Huang, Juin-Hua ; Ho, Yu-Hsin ; wang, Chang Yi ; Hwang, Kao-Pin ; Liu, Hope ; Kuo, Besheng ; Peng, James ; Lan, Yu-Rou ; Liang, Jian-Jong ; Shen, Hsuan-Yu ; Shen, Daphne ; Kuo, Hui-Kai ; Ding, Shuang ; Monath, Tom ; King, Chwan-Chuen King ; Shih, Hao-Yu ; Hanson, Carl ; Kemp, Tracy ; Liu, Zhi ; Yang, Ya-Ting ; Lin, Feng ; Chou, Yu-Chi ; Wu, Huang-Ting ; Morris, Mary Kate ; Hou, Kuo-Liang ; Cheng, Jennifer ; Liao, Chun-Che ; Wang, Min-Sheng ; Hellerstein, Michael

AbstractSARS-CoV-2 breakthrough infection occurs due to waning immunity time-to-vaccine, to which the globally-dominant, highly-contagious Delta variant is behind the scene. In the primary 2-dose and booster series of clinical Phase-1 trial, UB-612 vaccine, which contains S1-RBD and synthetic Th/CTL peptide pool for activation of humoral and T-cell immunity, induces substantial, prolonged viral-neutralizing antibodies that goes parallel with a long-lasting T-cell immunity; and a booster (3rd ) dose can prompt recall of memory immunity to induce profound, striking antibodies with the highest level of 50% viral-neutralizing GMT titers against live Delta variant reported for any vaccine. The unique design of S1-RBD only plus multitope T-cell peptides may have underpinned UB-612’s potent anti-Delta effect, while the other full S protein-based vaccines are affected additionally by mutations in the N-terminal domain sequence which contains additional neutralizing epitopes. UB-612, safe and well-tolerated, could be effective for boosting other vaccine platforms that have shown modest homologous boosting. [Funded by United Biomedical Inc., Asia; ClinicalTrials.gov ID: NCT04967742 and NCT04545749]

100 Deals associated with United Biomedical, Inc. Asia

100 Translational Medicine associated with United Biomedical, Inc. Asia

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