Second cohort underway in non-Hodgkin’s lymphoma patients
San Diego, CA, USA – March 19, 2015 –HUYA Bioscience International (HUYA) has completed the first cohort in a Phase 1 clinical trial in Japan of its cancer drug HBI-8000, a novel oral histone deacetylase (HDAC) inhibitor. This follows acceptance by the Pharmaceutical and Medical Devices Agency (PMDA) of the company’s accelerated development strategy in Japan.
The Phase 1 open-label, dose escalation trial is evaluating the safety and pharmacokinetics of HBI-8000 in Japanese patients with non Hodgkin’s lymphoma. The first cohort received HBI-8000 tablets twice weekly, with no dose-limiting toxicities observed. The second cohort is now underway with a higher dose. The trial is designed to establish a maximum tolerated dose (MTD) to proceed to Phase 2 trials for the treatment of adult T-cell leukemia/lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) in Japan.
“This is an exciting milestone in the global development of this novel cancer treatment as a monotherapy in hematological cancers or as a combination therapy in solid tumors,” said Mireille Gillings, Ph.D., CEO of HUYA. “The initiation of clinical trials of HBI-8000 in Japan follows the recent approval of the drug by the Chinese FDA; in China, the drug is known as chidamide, and is being developed in that country by Shenzhen Chipscreen Biosciences.”
The clinical development of HBI-8000 in Japan leverages clinical data from Chinese clinical trials through the Tripartite Cooperation on Health between China, South Korea and Japan. Shenzhen Chipscreen Biosciences recently announced the approval of chidamide in China as the world’s first oral HDAC inhibitor for the treatment of relapsed or refractory PTCL. HUYA holds exclusive rights to chidamide (HBI-8000) worldwide, excluding China, and is developing the compound for hematological malignancies and solid tumors.
About HBI-8000 (chidamide)
HBI-8000 (chidamide) 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 such as activation of NK- and CD8 T-cell-mediated antitumor activity, as well as repression of genes associated with drug resistance. To date, HBI-8000 has been dosed in various types of hematological and solid tumors in several clinical trials, including a Phase 1 trial completed in the United States.
About NHL, PTCL and ATL
Lymphoma is the most common blood cancer. The two main forms of lymphoma are Hodgkin’s lymphoma and non-Hodgkin’s lymphoma (NHL). Lymphoma occurs when lymphocytes, a type of white blood cell, grow and multiply uncontrollably. There are approximately 138,000 cases and 53,000 NHL deaths per year in the U.S. and Europe. NHL is the seventh most commonly diagnosed cancer in both men and women in the U.S. Peripheral T-cell lymphoma (PTCL) comprises a group of rare and usually aggressive NHLs that develop from mature T-cells. Most T-cell lymphomas are PTCLs, which collectively account for about 10 to 15 percent of all NHL cases in the U.S. In Japan, the rate of PTCL is estimated at 2-3 people per 100,000. The most common form of T-cell lymphoma in Japan is adult T-cell lymphoma/leukemia (ATL) caused by HTLV-1 infections. ATL represents a high unmet medical need and accounts for about 30% of all T-cell lymphomas in Japan, where ATL is responsible for approximately 1,000 deaths per year. HTLV-1, the virus that causes ATL, has a high prevalence in Japan, with more than one million people infected. Worldwide, HTLV-1 infects an estimated 10 million or more, and is endemic in countries including the Caribbean islands and certain regions of Africa, Central and South America and the Middle East.
About HUYA Bioscience International
HUYA Bioscience International is a leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. HUYA has established extensive collaborations 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 and the largest team of scientists working with Chinese innovators, HUYA has emerged as the partner-of-choice for building and maximizing the value of biopharmaceutical innovation in China. HUYA has offices in the U.S., Japan and in eight strategic locations across China, with joint headquarters in San Diego and Shanghai. HUYA identifies and advances promising drug candidates globally.
Jill Dawson, Ph.D.
HUYA Bioscience International