United BioPharma Received Approval from Taiwan FDA for a Phase 1 Trial with UB-421 Subcutaneous Formulation in HIV-1 Infected Patients
Taipei, Taiwan –Aug. 5 2020 –United BioPharma (UBP) announced today that they have received approval of an Investigational New Drug (IND) from Taiwan Food and Drug Administration (TFDA) 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.
This trial is an open label, multi-dose study (weekly injection of UB-421 SC at 250 mg, 500 mg and 700 mg for four weeks followed by standard ART), to evaluate the safety, pharmacokinetics, and antiviral activity of UB-421 SC in HIV-1 positive, asymptomatic adults who have no prior or current treatment with anti-retroviral drugs. A total of 18 eligible subjects (six per cohort) will be enrolled in this trial.
The new UB-421 SC formulation is developed to provide a more convenient delivery method as compared with the IV route, so that patients can easily self-administer the medication at home, and patient’s treatment compliance may also be improved. UB-421 SC is produced from a relatively high yield clone and formulated into a lyophilized form as the final drug product. Upon reconstitution with Water-for-Injection (WFI), a highly concentrated UB-421 suitable for subcutaneous injection is generated. Preclinical studies demonstrate that UB-421 SC is equally potent as the IV formulation in neutralizing HIV and suppressing viral load in animal models.
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 a multi-nation, 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 clinical stage biopharmaceutical company, founded in 2013 as a spin-off from UBIAsia, its parent company. UBP is dedicated to the research, development and manufacture of novel monoclonal antibodies (mAbs) for infectious diseases, cancer and immune disorders. UBP’s Headquarter is located in Taiwan, with subsidiary companies in Shanghai and Yangzhou China, and liaison offices in the U.S. The company has a highly passionate global team, developing first-in-class, best-in-class therapeutic mAbs and delivering high-quality, affordable treatments to bring a better quality of life to patients.
For more detailed information, please visit the website at: http://www.unitedbiopharma.com
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Dr. Mei June Liao, Executive Vice President, Product Development
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