– United BioPharma’s novel antibody suppresses HIV without eliciting resistance
TAIPEI, Taiwan, April 17, 2019 — United BioPharma (UBP) today announced that its monoclonal antibody product, UB-421, is able to suppress HIV for at least four months in patients who previously paused their antiretroviral therapy (ART) regimen. The results of the study were published in The New England Journal of Medicine (NEJM). The article, “Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound after Treatment Interruption,” appears in the April 18 issue of NEJM and reports on the ability of UB-421 to maintain viral remission without inducing antibody-resistant HIV production and the safety of the antibody.
“Durable maintenance of viral remission with a single agent such as UB-421 is unprecedented. This breakthrough opens up a host of potential new treatment options for patients with resistance-prone HIV infections. We are currently planning a series of Phase 2 and Phase 3 trials to assess UB-421 for use in long-term ART-substitution, multi-drug resistance infections and as a functional cure,” said Chang Yi Wang, Ph.D., Chief Scientific Officer and Chairperson of UBP.
In the study conducted in Taiwan, 29 volunteers discontinued their normal daily regimen of ART and received weekly or biweekly injections of UB-421. Fourteen study participants received weekly injections of UB-421 over eight weeks while 15 received a higher dose biweekly for 16 weeks. All participants in both groups who completed their regimen maintained HIV suppression throughout the treatment period. Previous Phase 1 and 2a clinical data are also included in the Appendix section of this report. Together, a total of 78 patients received the UB-421 treatment in various phases of studies.
Previous studies using broadly neutralizing antibodies as a single agent to substitute for ART have shown transitory success, suppressing HIV for a few weeks, but the rapid mutation rate of HIV leads to the development of resistant strains. UB-421 avoids the development of resistance by blocking the HIV competitive binding sites on an immutable human protein that HIV uses to infect T cells. Collaborators at the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health, provided additional analyses and laboratory support for the study.
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 a Phase 2, 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. Be-Sheng Kuo, Senior Vice President of Clinical Pharmacology
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