SAN DIEGO, March 15, 2016 /PRNewswire/ -- HUYA Bioscience International (HUYA), the leader in accelerating global development of China's pharmaceutical innovations, today announced it has signed an exclusive license with Fudan University for the ex-China rights to a series of novel immuno-oncology drug candidates discovered by Fudan researchers. The agreement includes a panel of novel inhibitors of indoleamine 2,3-dioxygenase (IDO) developed for more than 10 years by the research group of professor Qing Yang of the School of Life Sciences at Fudan University. The IDO pathway is one of several immune response checkpoints thought to play an important role in suppressing T-cell function, allowing tumors to avoid immune surveillance. HUYA plans to advance the products into clinical testing in parallel with the ongoing development of HBI-8000, HUYA's novel histone deacetylase inhibitor, which has been shown to demonstrate its own immunomodulatory properties.
"HUYA was the first company to recognize China's potential as an important source of innovative preclinical stage compounds for worldwide development," said Dr. Mireille Gillings, CEO & Executive Chair of HUYA. "We are pleased to continue HUYA's track record of identifying the most promising new therapeutics from premier institutions in China--in this case with Fudan University, which produces world class researchers and science."
Dr. Li Jin,Vice-president of Fudan University & Academician of Chinese Academy of Sciences said, "We are pleased to be working with HUYA on this program. Their expertise will help to maximize global value and showcase Fudan's world-class research capabilities."
The agreement with Fudan builds in a powerful way relationships with important research institutions in China that are leading a new generation of innovation in Life Sciences.
"These new IDO compounds will dramatically expand our immuno-oncology platform, enabling combination therapy with other drugs to address the limitations of immune therapy due to checkpoint T cell suppression," said Bob Goodenow, PhD, HUYA's CBO.
HBI-8000 is a member of the benzamide class of histone deacetylase (HDAC) inhibitors designed to block the catalytic pocket of Class I HDACs. HBI-8000 is an orally bioavailable, low-nanomolar inhibitor of cancer-associated HDAC enzymes with favorable pharmacology and safety profiles. HBI-8000 inhibits cancer-associated Class I HDAC1, HDAC2, HDAC3, as well as Class IIb HDAC10 at nanomolar concentrations and stimulates accumulation of acetylated histones H3 and H4 in tumor cells. Studies with human-derived tumor cell lines have demonstrated that HBI-8000 inhibits the growth of many tumor cell lines via multiple mechanisms of action, including epigenetic regulation of tumor cell growth and apoptosis, immunomodulatory effects regulating antitumor activity, as well as repression of genes associated with drug resistance. HBI-8000 became the first benzamide HDAC inhibitor approved worldwide when the drug was approved for the treatment of peripheral T cell lymphoma (PTCL) in China, where it is now marketed under the trade name Epidaza. In 2013, HUYA was the first company to use the China-Japan-Korea Tripartite Cooperation Treaty to reach an accelerated development path for Non-Hodgkin's Lymphoma with Japan's Pharmaceutical and Medical Devices Agency (PMDA) based on the China data. In 2015, Japan's Ministry of Health, Labour and Welfare granted HBI-8000 orphan drug designation for the treatment of PTCL. In 2016, HUYA and Eisai Co. Ltd signed an agreement for exclusive rights to HBI-8000 in Japan and 7 other Asian countries. Under the terms of the agreement, HUYA will continue the development in lymphoma through regulatory approval. Eisai will commercialize the product for lymphoma and other future indications including for solid tumors.
HUYA Bioscience International is the leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. Extensive collaborations are established with Chinese biopharmaceutical, academic and commercial organizations to speed development and value creation in worldwide markets for China-sourced product candidates. With the largest Chinese compound portfolio covering all therapeutic areas, HUYA has emerged as the partner-of-choice for maximizing the value of biopharmaceutical innovation in China. In addition to the lead compound HBI-8000, the Company also has two other pipeline drugs in development for arrhythmia and acute myocardial infarct. HUYA has offices in the U.S., Japan, South Korea and eight strategic locations across China. With the largest team of scientists working with Chinese innovators, HUYA identifies and advances promising drug candidates globally. HUYA received the Asia-Pacific Stevie(R) Award in the Health Products and Services & Pharmaceuticals category and Dr. Mireille Gillings received the Gold Stevie Award in the Woman of the Year 2015 American Business Award category. For more information, please visit www.huyabio.com.
About Fudan University
Fudan University, founded in 1905, is a comprehensive national key university with a long history and enjoys a good reputation both at home and abroad. With the national "211 project" and "985 project" providing continued support, the college vigorously develops excellence in arts, science, engineering and medicine. Fudan continually improves its teaching staff, a innovative talented team of 2660, with more than 75% with doctorates. The University actively undertakes major scientific research projects, steadily promotes independent innovation, and is responsible for national major projects for top colleges and universities. Major innovations constantly emerge from Fudan. From 2006 to 2012, it won 18 state science and technology first place awards; and Gu Chaohao, academician, has won State Science and Technology Top Awards. From 2010 to 2012, it had published 25 papers in Science, Nature, and Cell; and the SCI and average number of references of papers both ranked third in the country. Established in the Yangtze River delta, the WuXi Institute and Ningbo Institute has formed a new industry-university-institute cooperation pattern, and has had obvious effects on social and economic growth.
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