BEIJING -- (BUSINESS WIRE) -- BeiGene (Beijing), Co., Ltd., an innovative oncology company focused on developing targeted and immune-oncology therapeutics, today announced the achievement of a clinical milestone in the company’s collaboration with Merck Serono, the biopharmaceutical division of Merck, Darmstadt, Germany, for BGB-283, a second-generation BRAF inhibitor candidate currently in Phase 1 development. The milestone triggers a US$ 5 million payment from Merck to BeiGene.
“We are very pleased to successfully reach this development milestone for BGB-283, as this exciting oncology candidate demonstrates the potential of BeiGene’s innovative translational research platform to deliver targeted therapeutics that address the unmet need of cancer patients,” said John V. Oyler, CEO of BeiGene. “We look forward to working with Merck Serono as it continues to progress through the clinic.”
In December 2013, BeiGene announced the enrollment of the first patient in a Phase 1 study of BGB-283 in patients with BRAF or KRAS mutations. BGB-283 is an investigational, oral, selective, potent-second generation inhibitor of BRAF, making it a targeted therapeutic candidate to potentially treat and bring benefit to patients with cancers that harbor BRAF mutations and/or aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway.
BGB-283 is part of BeiGene’s two-asset strategic collaboration with Merck that was established in 2013.
About the Study
The Phase 1 multicenter, 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. The study is expected to only enroll subjects who have BRAF or KRAS mutations. Key objectives in the study include determining maximum tolerated dose, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BGB-283. Disease-specific expansion cohorts will be enrolled at the maximally tolerated or biologically relevant dose.
About BRAF Mutation and the RAS-MAPK Pathway
The mitogen-activated protein kinase (MAPK) pathway comprises several key signaling components that play critical roles in tumorigenesis. Alteration of the RAS-MAPK pathway has frequently been reported in human cancer as a result of abnormal activation of receptor tyrosine kinases or gain-of-function mutations mainly in the RAS or RAF genes. Activating mutations of the RAS family genes (HRAS, KRAS, and NRAS) comprise up to 30% of all human cancers. BRAF mutations also have been reported in 7-8% of all human cancers. Accordingly, components of this pathway are important therapeutic targets for cancer treatment.
About BeiGene (Beijing), Co., Ltd.
BeiGene is an innovative Chinese oncology R&D company focused on discovering, developing and commercializing targeted and immune-oncology therapeutics through a novel translational research platform that combines unique access to internal patient-derived biopsies with strong oncology biology. With a team of 150 scientists and staff, its pipeline is comprised of novel oral small molecules and monoclonal antibodies for cancer. BeiGene Ltd. is a Cayman Islands exempted company that is an investor in and collaborator with BeiGene (Beijing), Co. Ltd. For more information, please visit our website at www.beigene.com.