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 UBP (6471)
UBP was established in September 2013 as a spinoff from United Biomedical, Inc., Asia, and is strategically partnering with Formosa Plastics Group. UBP has an integrated monoclonal antibody drug development platform, and focuses on development, manufacturing, and marketing of innovative monoclonal antibody drugs and biosimilars. With a spirit of “innovation and practicality,” UBP is dedicated to addressing unmet medical needs, thereby improving the health of mankind and economic advancement of Taiwan. For more information, please visit http://www.unitedbiopharma.com
UB-421 is a humanized monoclonal antibody, which recognizes and binds to domain 1 of the CD4 molecule, the same site for HIV virus binding. This direct competition for binding to CD4 is termed competitive inhibition and effectively blocks the entry of HIV virus into CD4+ cells, thus inhibiting HIV infection. Competitive inhibition also prevents generation of drug resistance resulting from the mutation of the HIV virus.
UB-421 is an innovative antibody drug developed solely by UBP. UBP has received the Technology Development grants from Taiwan government five times, won the Silver Prize in 2012 and Gold Prize in 2014 of the Pharmaceutical R&D Award. UBP also won the Gold Prize of the Taipei Biotech Award for its innovative R&D, and was selected as a Flagship Project and a Cross-Strait Pilot Program of Pharmaceutical Collaborative Development by the Taiwan FDA. UBP’s achievement in R&D and UB-421’s potential to treat AIDS have been repeatedly recognized.
United BioPharma Forward-Looking Statements
The information in this press release should be considered accurate only as of the date of the release. UBP has no intention of updating and specifically disclaims any duty to update the information in this press release. The press release may contain forward-looking statements involving risks and uncertainties and UBP’s actual results may differ materially from those in the forward-looking statements.
Victor Run-Ben Sun
Spokesperson and Vice President of Administration & Legal Affairs
+886-3-6684800 # 3808