UB-621 Long-Acting Herpes Treatment Description
United BioPharma UB-621 is a long-acting treatment for genital herpes caused by simplex viruses 1 and 2 (HSV-1 and HSV-2). UB-621 is an anti-gD mAB that has demonstrated strong viral suppression of transmission and recurrence of HSV1 and HSV2.
UB-621 is a novel, fully human monoclonal antibody that interferes with HSV infection by binding specifically to HSV envelope glycoprotein D (gD). It can neutralize both wild-types HSV lab strains and multi-drug-resistant clinical isolates. UB-621 has been demonstrated to exhibit a high-affinity binding (Kd, 3.6 × 10-11 M) to gD protein and high potency against both HSV-1 and HIV-2 infections. UB-621 also shows the capability to inhibit the cell-to-cell spread of HSV-1 and HSV-2.
UB-621 has been developed over 10 years of research collaboration between the University of Washington, the National Institute for Allergy and Infectious Diseases, the University of Duisburg Essen, Germany, and Dartmouth College. The new UB-421 SC formulation was developed to provide a convenient delivery method as compared with the IV route so patients can self-administer the medication.
UBP’s cell-line, process development, protein analysis, and formulation methods empower the develop a high titer, robust, scalable cell culture and establish an optimized-yield and robust monoclonal antibody drug purification process. UBP has developed more than 30 analytical development methods and validation for physiochemical and protein characterization, drug formulation development, comparability studies, and quality control.
Shanghai Public Health Clinical Centre and Cheng Kung University's Department of Microbiology and Immunology have joined United BioPharma's fight against the global herpes endemic. Together with United BioPharma, the two institutions will test the effectiveness of UB-621 in the United States and China.
UBP's Headquarters Centers of Excellence in R&D and Manufacturing is located at 45-1 Guangfu N. Rd., Hukou Industrial Park, Hukou Township, Hsinchu County, TAIWAN 30351.
UB-621 Long-Acting Herpes Treatment Indication
UB-621 is indicated to treat HSV1 and HSV2. United BioPharma's UB-621 – with a half-life of 23-28 days - is administered via subcutaneous injection and targets surface glycoprotein gD found to inhibit viral entry into cells. A subcutaneous liquid formulation may allow a monthly or quarterly dosing scheme to treat HSV infection.
UB-621 Long-Acting Herpes Treatment Dosage
Earlier in an open-label, dose-escalation Phase 1 study, UB-621 was demonstrated to be safe and well-tolerated in 15 healthy volunteers receiving a single subcutaneous injection at doses ranging from 0.1 mg/kg to 5 mg/kg.
The phase 2 study is evaluating 2.5 mg/kg UB-621 group mAb, and by SC administration 5 mg/kg UB-621 group.
UB-621 Long-Acting Herpes Treatment News
October 18, 2021 - UB-621 will be heading into Phase 2 clinical trials in the United States and China. "Data from our initial trials suggest that UB-621 is not only a best-in-class treatment but a potential game-changer for billions of patients suffering from herpes worldwide Testing on clinical isolates will help confirm whether UB-621 can work well against herpes strains, especially those that have already been shown to be resistant to currently marketed drugs", said Dr. Shugene, Lin, President of United BioPharma.
July 13, 2021 - United BioPharma announced that its subsidiary company in Shanghai has received Investigational New Drug approval from China's National Medical Products Administration for a larger Phase 2 clinical trial with UB-621.
November 10, 2020 - United BioPharma announced they had received Investigational New Drug approval from China National Medical Products Administration to conduct a Phase 2 clinical trial with UB-621.
August 5, 2020 - United BioPharma (UBP) announced today that they have received approval of an Investigational New Drug from the Taiwan Food and Drug Administration to conduct a Phase 1 clinical trial with UB-421 SC, an anti-CD4 monoclonal antibody formulated for subcutaneous injection in treatment-naïve, HIV-1 infected patients.
UB-621 Long-Acting Herpes Treatment Clinical Trials
UB-621 has completed a Phase 1 clinical trial and is preparing to enter into 3 Phase 2 clinical trials.