UBI集團訊息
United Biopharma Submitted completed anti-HIV therapeutic mAb UB-421 Phase II Clinical Trial Report, to TFDA for review
This phase II trial was conducted to evaluate the safety and efficacy of UB-421 monotherapy in substitution for stable antiretroviral therapy(HAART) in HIV-1 infected patients. The HIV viral load is well controlled at a certain level by antiretroviral therapy (HAART). During the treatment period of 16 weeks, no viral rebound was observed in all patients administered UB-421 by injection, i.e. the trial met the primary endpoint in 100% of the participants Based on the phase II results, UBP has filed an IND to TFDA to conduct a phase III clinical trial, which is a randomized, open-label, controlled trial to investigate the efficacy and safety of UB-421 monotherapy as substitution for stable antiretroviral therapy in HIV-1 infected adults. Once the trial is approved and initiated, UBP aims to complete the phase III clinical trial in two years.
About United BioPharma (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 the development, manufacture and marketing of innovative monoclonal antibody drugs and biosimilars. With a spirit of “innovation and practicality,” UBP is dedicated to addressing unmet medical needs to improve the health of mankind.
About UB-421
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 by UBP. UBP has received Technology Development grants from Taiwan government four 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 achievements 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.