United Biopharma obtains approval from the U.S. FDA to conduct a clinical trial with UB-421 in Patients with Multi-Drug Resistance HIV-1 infection
Taipei, Taiwan, May 21, 2019 -- United BioPharma (UBP) announced today that the company has obtained U,S. FDA’s approval to conduct a clinical trial with UB-421 in the USA, under the protocol entitled “A Multicenter, Single-Arm, 24-Week Study of UB-421 in Combination with Optimized Background Therapy (OBT) Regimen in Patients with Multi-Drug Resistant (MDR) HIV-1 Infection.”
Although HIV infection is manageable with a combination of two or more small molecule antiretroviral drugs, i.e. Antiretroviral Therapy (ART), a 4-8% small percentage of treated patients, who initially achieve viral suppression on effective ART, still develop persistent, low level plasma viremia . In other words, these patients have developed multi-drug resistance (MDR) to HIV and have exhausted treatment options, such that exposing to a high risk of AIDS complications and eventual progression to death.
In this study protocol, the eligible study participants will receive a single intravenous infusion of 5 mg/kg UB-421 plus their failing regimen in the first week, with a primary endpoint to achieve at least 0.5 log reduction in plasma viral load at the end of the week. The participants will then receive weekly 5 mg/kg UB-421 doses plus Optimized Background Therapy (OBT) Regimen for 24 weeks during the maintenance treatment period.
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. Both the murine and humanized mAbs bind to CD4+ T cells with approximately 50-100-fold higher affinity than HIV-gp120. UB-421 has been shown to inhibit viral entry with remarkable viral load reduction potency in Phase 1 and Phase 2a clinical studies involving treatment-naïve HIV-infected patients. In the Phase 2 study with ART-stabilized HIV-infected patients, UB-421 monotherapy maintains viral suppression for up to 16 weeks without viral rebound in the absence of ART. UB-421 is currently in the stage of a multi-nation and multi-center clinical trial for ART substitution, as well as other trials for multi-drug resistance and proof-of-concept study of HIV functional cure.
About United BioPharma
United BioPharma (UBP) is a multi-national clinical-stage biopharmaceutical company dedicated to the research, development and manufacture of innovative and biobetter monoclonal antibody therapeutics for treatment of infectious, cancerous and immunological diseases. With R&D and manufacturing conducted at UBP’s headquarters in Hsinchu Industrial Park (Hukou), clinical research centered at the laboratories in Hsinchu Biomedical Park (Zhubei), and business operations at offices at Taipei 101, UBP is effectively positioned to employ its cutting edge and solid integrated technology platform and utilize its state-of-the-art research and manufacturing facilities to address unmet medical needs in mankind and to improve patient health and quality of life. UBP has its liaison offices in Long Island, New York; a research base for clinical development and regulatory affairs in Shanghai; a clinical laboratory, and pilot as well as commercial scale protein drug GMP manufacturing facilities currently being established in Yangzhou, China.
For more information, please visit http://www.unitedbiopharma.com
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.
Dr. Mei June Liao, Executive Vice President, Product Development
+886-3-5979288 # 6700
1.Ryscavage P, et al., Significance and clinical management of persistent low-level viremia and very-low-level viremia in HIV-1-infected patients. Antimicrob Agents Chemother. 2014;58:3585-3598
2.Murray AJ, et al. The latent reservoir for HIV-1: How immunologic memory and clonal expansion contribute to viral persistence. J Immunol. 2016;197:407-417.
3.Chun TW, et al. Rebound of plasma viremia following cessation of antiretroviral therapy despite profoundly low levels of HIV reservoir: implications for eradication. AIDS. 2010;24:2803-2808.
4.Chun TW, Fauci AS. HIV reservoirs: pathogenesis and obstacles to viral eradication and cure. AIDS. 2012;26:1261-1268.