United Biopharma (UBP, 6471) today announced that the Taiwan Food and Drug Administration (TFDA) has approved the company’s application to conduct a phase I clinical trial of UB-921 for the treatment of HER2-positive breast cancer.
The phase I trial of UB-921 is designed to evaluate the safety, tolerability and pharmacokinetics of the drug on healthy volunteers.
Traditional chemotherapy for cancers works on inhibiting cell division and DNA synthesis of the tumor cells, however, the anti-cancer drugs not only attack the tumor cells but also kill the normal cells, resulting in considerable side effects. The biopharmaceutical, monoclonal antibodies (mAbs) therapeutics such as Herceptin® work like a magic bullet, targeting the antigens dysregulated in cancers, and therefore generate more significant efficacy with limited side effects.
In the United States alone, 1 in 8 women (about 12%) will develop invasive breast cancer over the course of her lifetime. In 2017, an estimated 252,710 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. Herceptin® is one of the top-selling drugs with 2016 global sales of US$6.8 billion.
UB-921 is a biosimilar candidate of Herceptin® (Trastuzumab) that targets the HER2 receptor, a protein found in high quantities on the outside of cells in HER2-positive cancers. The pre-clinical studies, including anti-proliferation assay, pharmacokinetics study in rats, toxicology testing in non-human primates and in vivo tumor growth inhibition assay, showed that UB-921 has highly comparable characteristics with its reference product Herceptin®.
About United BioPharma (6471)
United BioPharma (UBP) was established in September 2013 as a spinoff from United Biomedical, Inc., Asia, and is strategically partnering with Formosa Plastics Group. UBP has an integrated monoclonal antibody drug development platform, and focuses on development, manufacturing, and marketing of innovative monoclonal antibody drugs and biosimilars. With a spirit of “innovation and practicality,” UBP is dedicated to addressing unmet medical needs, to improve the health of mankind. For more information, please visit http://www.unitedbiopharma.com
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Victor Run-Ben Sun
Spokesperson and Vice President of Public Affairs