United BioPharma Received Approval from China NMPA for a Phase 1 Trial with UB-221 in Healthy Volunteers
Taipei, Taiwan – Mar. 20 2020 –United BioPharma (UBP) announced approval of an Investigational New Drug (IND) application from China National Medical Products Administration (NMPA) to conduct a phase 1 clinical trial with the company’s anti-IgE UB-221 monoclonal antibody (mAb).
The phase 1 trial is an open label, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of UB-221 in 15~30 healthy volunteers. Another phase I trial of UB-221 in patients with moderate to severe chronic spontaneous urticaria (CSU) is currently underway in Taiwan. (ClinicalTrials.gov Identifier: NCT03632291). A similar clinical trial protocol with UB-221 has also been approved by the US FDA in November 2019.
UB-221 is a humanized, anti-IgE antibody with unique properties not only to neutralize serum free IgE but also inhibit the IgE synthesis by B cells. UB-221 binds free IgE and blocks its binding to the high-affinity receptor FcεRI on mast cells and basophiles, so as to inhibit the release of allergic factors such as histamines, proteases, and inflammatory cytokines. UB-221 can also inhibit the production of new IgE by binding to the IgE already bound on the low-affinity receptor CD23 (FcεRII), a unique IgE binding nature not shared by Xolair® (Omalizumab), the only anti-IgE mAb approved for clinical use.
In the preclinical, UB-221 exhibits a 3- to 8-fold higher activity in regard to IgE binding, neutralization of IgE binding to the receptor FcεRI, reduction of new IgE synthesis, and suppression of de-granulation from allergic basophils, as compared to Xolair®. A PK study in cynomolgus monkeys demonstrated UB-221 has a longer serum half-life (~11 days with SC administration) than Xolair®.
Anti-IgE therapy by controlling IgE levels in the body has been identified as a new treatment option for allergic diseases. Potential indications of UB-221 include IgE-mediated allergies such as chronic spontaneous urticaria, allergic asthma, allergic rhinitis, food allergies, and atopic dermatitis.
UB-221 is a humanized IgG1 that targets the Cε3 domain of IgE antibody. UB-221 is not only able to neutralize free/soluble IgE, but also to inhibit the IgE synthesis by binding to IgE on FcεRII (CD23) receptor on the surface of B cells. According to pre-clinical studies, UB-221 is superior to the currently marketed anti-IgE therapeutic antibody by 3 to 8-folds in terms of pharmacologic effects. Currently, a first-in-human, phase I, open-label, and dose-escalation clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with chronic spontaneous urticaria (CSU) is in progress in Taiwan.
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 research, development and manufacturing 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 global team, highly passionate about developing first-in-class, best-in-class therapeutic mAbs and delivering high-quality, affordable medicines to bring better life to the 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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