BEIJING, Oct. 12, 2015 (GLOBE NEWSWIRE) -- BeiGene, Ltd., a clinical-stage biopharmaceutical company focused on developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the first patient has been dosed with BGB-283 in a Phase I clinical trial in China, a novel RAF dimer inhibitor for the treatment of solid tumors harboring B-RAF mutations and other aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway. The study is being conducted across multiple centers in China.
"We are extremely excited about the initiation of the BGB-283 study in China. This is another important milestone for BeiGene" said John V. Oyler, Chief Executive Officer. "BGB-283 represents one of the BeiGene compounds supported by China's 12-5 Major New Drugs Development Projects. We hope that this novel targeted anti-cancer agent will bring benefits to cancer patients in China."
"Ongoing clinical trials of BGB-283 in Australia and New Zealand have shown promising early anti-tumor activities as well as a favorable safety profile," Jason Yang, MD, PhD, Senior Vice President, Head of Clinical Development commented. "We will explore the safety and tolerability, and the antitumor activity of BGB-283 in cancer patients in China."
The clinical trial in China will investigate BGB-283 in patients with B-RAF mutations in a range of tumors for which no other effective standard therapies are currently available in China. Additionally, BGB-283 will be investigated in patients with K-RAS/N-RAS mutated cancers and hepatocellular carcinoma (HCC).
The phase I multi-center, open-label, dose escalation clinical trial of BGB-283 is designed to assess the safety, tolerability and pharmacokinetic properties of BGB-283 as a single agent. Key objectives in the study include determining the maximum tolerated dose, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BGB-283 in Chinese patients. Disease-specific expansion cohorts will be dosed to investigate the preliminary anti-tumor activity of BGB-283 in selected solid tumors.
BGB-283 is a novel RAF inhibitor with unique RAF dimer and EGFR inhibition activity. BGB-283 shows promising antitumor activities in the preclinical models and in cancer patients not only with B-RAFV600E mutation but also with non-V600E B-RAF mutation and K-RAS/N-RAS mutations. BeiGene retains exclusive development and commercial rights to BGB-283 in China; we have granted an exclusive license to develop and commercialize BGB-283 to Merck KGaA for markets outside of China.
B-RAF monomer inhibitors which selectively target mutant B-RAFV600Ehave exhibited significant clinical activities in melanoma patients with the B-RAFV600E mutation. They are approved for the treatment of patients with B-RAFV600E melanoma. However, B-RAF monomer inhibitors have limited clinical activity outside of melanoma, thyroid and non-small cell lung cancers with B-RAFV600E mutation and the patients developed resistance to the drugs relatively quickly.
BeiGene is a global, clinical-stage, research-based company focused on targeted and immuno-oncology therapeutics. With a team of 175+ scientists and staff, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions that will have both a meaningful and lasting impact on cancer patients. For more information, please visit our website at www.beigene.com.
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