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National Institute of Health Study: UB-421’s HIV Suppression is Superior to 4 Other Broadly Neutralizing Antibodies

Dr. Tae-Wook Chun and his colleagues in Dr. Anthony Fauci’s laboratory at the National Institute of Allergy and Infectious Diseases, NIH, with the NIH-supported AIDS Clinical Trials Group (ACTG) published their latest clinical data on VRC01 (a broadly neutralizing antibody to HIV, bNAb) in people living with HIV in the New England Journal of Medicine (November 24, 2016). In this publication, United BioPharma (UBP)’s UB-421 (an anti-CD4 antibody, which works by a different mechanism than VRC01) was included in the in vitro evaluation of neutralization capability against the HIV isolated from the trial participants. The anti CD4 antibody UB-421 was shown to have greater effect in vitro when compared to the traditional anti-HIV antibodies, VRC01 and 3 other bNAbs.

A total of 24 participants were enrolled in two phase I clinical trials (ACTG and NIH), and treated with VRC01 (monotherapy) prior to and following discontinuation of antiretroviral therapy (ART). Viral rebound was observed despite high plasma VRC01 concentration (> 50 µg/mL). The median time to rebound was 4 weeks and 5.6 weeks for the ACTG and NIH trials, respectively, suggesting that VRC01 monotherapy can only temporarily replace ART. The researchers demonstrated the persistence of pre-existing and emergence of resistant HIV to VRC01. The data from in vitro neutralization assays involving 182 replication-competent HIV strains isolated from the study participants before and after VRC01 infusion showed that UB-421 was effective in blocking HIV entry when compared to VRC01 and 3 other bNAbs:3BNC117, 10-1074, and PGT121. Of great interest, UB-421 also effectively blocked those HIV isolates that were resistant to those bNAbs (for details, refer to Fig.4A in main article and Fig. S14 in Supplementary Material of this article). UB-421 is currently being evaluated in clinical trials for HIV treatment and viral suppression by the mechanism of HIV entry inhibition.

Source of Article:

KJ Bar et al. Effect of HIV-specific antibody VRC01 on viral rebound after treatment interruption . New England Journal of Medicine, Nov. 24, 2016, Vol.375 No.21, 2037-2050.

About United BioPharma (6471)

Founded in October 2013, United BioPharm (UBP) was spun-off from its parent company, United Biomedical, Inc., Asia, to focus on its monoclonal antibody drugs business. UBP has established a strategic partnership with Taiwan conglomerate, Formosa Plastics Group and its Chang-Gung Memorial Hospital network. UBP possesses a comprehensive technology platform for antibody drug development and is focused on the R&D, manufacture, and global commercialization of innovative monoclonal antibodies and biosimilar antibodies with significant market potential. Driven by innovation and execution, UBP strives to provide effective therapeutics to address unmet medical needs, improve human health and contribute to Taiwan’s economic development.

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