United BioPharma Receives US FDA Approval for UB-621 Phase 2 Trial in Recurrent Genital Herpes Patients
Taipei, Taiwan, June 10th , 2019 -- United BioPharma (UBP) announced the receipt of Investigational New Drug (IND) approval from the U.S. FDA to conduct a phase 2 clinical trial with UB-621 monoclonal antibody for recurrent genital infection caused by Herpes Simplex Virus, type II (HSV-2). UB-621 works to inhibit the infection through high-affinity binding to the same epitope on viral surface envelope gD protein on both type I (HSV-1) and type II (HSV-2) viruses.1
The phase 2 clinical trial is a multi-center, randomized, double-blind, and placebo controlled study to be conducted in the U.S., and led by Principle Investigator, Dr. Anna Wald, the Head of Allergy and Infectious Diseases Division and professor of Medicine, Laboratory Medicine & Epidemiology at University of Washington, Seattle.
The phase 2 study will evaluate the safety and efficacy of UB-621 on HSV shedding in adults with recurrent genital infection following a single subcutaneous (SC) dose at 2.5 or 5.0 mg/kg. UB-621 in an earlier phase 1 trial with healthy human volunteers conducted in Taiwan has been shown to be safe and well tolerated, with a remarkably long elimination half-life of 25 days.
Genital Herpes (GH) disease is a life-long HSV-2 infection of the genitalia and urogenital tract. It is one of the most common sexually transmitted infections and is a leading cause of genital ulcers around the world. Patients with GH infection would suffer from recurring episodes of symptom outbreaks, which usually involve painful ulcerations. GH infection has been viewed as a significant global public health problem, as it can also assist and exacerbate the transmission of human immunodeficiency virus 1 (HIV-1).
Currently no effective preventative vaccine or cure for GH infection, and the treatment landscape is dominated by generic nucleoside acyclovir analogues. Despite the effectiveness of these drugs in managing the symptoms in the majority of patients, the lack of treatment alternatives and the shortcomings of the current treatments have stimulated investments in new treatment options for this vast patient population.
Of interest to note as well, UB-621 binds to the same epitope on the gD envelope protein shared by both HSV-1 and HSV-2 viruses. UB-621 has been shown in vitro to block HSV-1 infections of wild type and acyclovir-resistant viral strains with over hundreds-fold higher potency.
UB-621, a fully humanized IgG1 monoclonal antibody, functions to block viral entry through binding to the surface envelope glycoprotein D (gD) of HSV, type I and type II. UB-621 has exhibited a high-affinity binding (Kd, 3.6 × 10-11 M) to gD and a high potency against both HSV-1 and HIV-2 infections.
UB-621, a subcutaneous (SC) liquid formulation product, has been demonstrated safe and well tolerated in healthy human volunteers in a phase I trial, where no anti-drug antibodies, clinically significant abnormality or dose limited toxicities (DLTs) were observed. UB-621 exhibits a long half-life of 25 days in humans, which may allow a monthly or quarterly dose scheme to treat HSV infection, type I or type II.
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
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Dr. Mei June Liao, Executive Vice President, Product Development
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1.Li C-C, et al. Structural basis for the antibody neutralization of herpes simplex virus. Acta Crystallogr. D Biol. Crystallogr. 2013 Oct;69 (Pt 10):1935-1945.