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Find Clinical Drug Pipeline Developments & Deals by United BioPharma
UB-421 is an Fc-aglycosylated, non-T cell depleting and CD4-specific humanized IgG1 derived from the parent murine B4, which binds to discontinuous, conformational epitopes on the HIV-receptor complex, including CD4 (domain 1), and competitively blocks HIV entry.
New results demonstrate a newer class of anti-IgE antibody, UB-221, with superior neutralization, synthesis reduction, and durable relief in targeting allergic diseases.
UB-221 shows 2 to 5-folds inhibition of IgE synthesis than Xolair in the in vitro study. UB-221 only takes 1/10 dose to achieve the same effect of Xolair in huIGHE-knock-in mice model. PK study in cynomolgus monkeys demonstrated UB-221 has a longer serum half-life than Xolair.
UB-421 is a strong entry inhibitor of HIV with proven ability to substitute for ART, and it may also enhance CD8 T cell cytotoxicity function and improve immune exhaustions .
The current Phase 2 study is a randomized, single-blinded, placebo-controlled study to investigate the efficacy and safety of single dose UB-621 treatment for recurrent genital herpes.
United BioPharma has received Investigational New Drug approval from the China National Medical Products Administration to conduct a Phase 3 clinical trial with UB-421, an anti-CD4 monoclonal antibody, in patients with multi-drug resistant HIV-1 infection.
This trial is an open label, multi-dose study, to evaluate the safety, pharmacokinetics, and antiviral activity of UB-421 SC in HIV-1 positive, asymptomatic adults who have no prior or current treatment with anti-retroviral drugs.
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