UBI Asia announces IND acceptance by TFDA to conduct the first-in-human (FIH) phase-I trial in adults allergic rhinitis patients for UB-211, an UBITh® Allergy Immunotherapeutic Vaccine
公佈日期:2019/09/25 by Ivy

Taipei, Taiwan, -- September 25, 2019
United Biomedical, Inc., Asia (UBIA) announced today that Taiwan Food and Drug Administration (TFDA) has accepted the Investigational New Drug (IND) application for its flagship human vaccine product UB-211, to be studied in adults with IgE-mediated allergic rhinitis (AR). The objective of this first-in-human (FIH) phase I trial is to evaluate the safety, tolerability and immunogenicity of UB-211.

About UB-211
UB-211, an UBITh® Allergy Immunotherapeutic Vaccine developed by UBI and UBIA, is designed to provide a cost-effective treatment for a broad-spectrum treatment of IgE-mediated allergic diseases including AR. The UB-211 immunogen contains a chemically synthesized peptide derived from the extracellular membrane proximal domain of IgE (IgE-EMPD), which is covalently linked to a UBITh® T helper peptide modified from measles virus fusion (MVF) protein. UB-211 induces IgE-EMPD-specific antibodies that can eliminate IgE-switched B cells and thus prevent formation of IgE-producing plasma cells, cutting off the source of IgE immunoglobulins, including those specific to all allergens.

Studies with guinea pigs, human IGHE knock-in mice and cynomolgus macaques have shown UB-211 to be effective in inducing anti-IgE-EMPD antibody responses that are long-lasting, i.e. over 10 months post last immunization observed in the mouse model. The vaccine-induced antibodies can bind and kill IgE-positive B cells through apoptosis and antibody-dependent cytotoxicity (ADCC). It is significant to note that UB-211 vaccination could reduce both total and allergen-specific IgE antibody levels, in preventive (vaccination prior to allergen challenge) and therapeutic (allergen challenge prior to vaccination) models. UB-211 vaccination was safe and well-tolerated in the studied animals.

About Allergic Rhinitis
Allergic rhinitis (AR) affects 10-30% of adults and 40% of children worldwide. The disease is caused by immunoglobulin E (IgE)-mediated type-I hypersensitive reaction of the immune system to environmental and harmless allergens. Clinical symptoms of AR are characterized by nasal congestion, anterior and posterior rhinorrhea, sneezing, and nasal itching secondary to IgE-mediated inflammation of the nasal mucosa. Although AR is not life-threatening, the disease can have a serious impact on the quality of life of those who are affected. In the United States, the annual cost related to AR is estimated to be up to USD 20.9 billion. In addition, poor AR management has been identified as a risk factor for the development of asthma.

Current first-line treatments of AR involve allergen avoidance and medications for symptom-relief (i.e., oral antihistamines, intranasal corticosteroids and leukotriene receptor antagonists). Nevertheless, up to 20% of AR cases are not sufficiently controlled by regular medical treatments.

About UBI Asia
United Biomedical, Inc., Asia (UBIA), teamed up with its parent United Biomedical, Inc. (UBI), is mainly engaged in research, development, and manufacturing of fully synthetic peptide-based human and animal vaccines, which are designed using the innovative, proprietary UBITh® platform technology.

Human vaccines under research and development include those for treatment of allergy, inflammation and autoimmune diseases, of which UB-211 targeting IgE-bearing B cells is the first to reach clinical trial for adult with allergic rhinitis. Other vaccines are targeting important cytokines for various allergy and autoimmunity indications. Animal vaccines under development include those for swine foot-and-mouth disease (FMDV vaccine), swine immunocastration , and pig blue ear disease (PRRS vaccine). The FMDV vaccine received the first class of veterinary drug certificate in China in 2007, and has sold over 4 billion doses in China through its affiiate Shen Lian Biomedical (aka UBI Shanghai Biomedical), while the LHRH vaccine is approved andhas been sold for swine immunocastration r use in Mexico, Brazil, Russia and Taiwan.