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BeiGene Enrolls First Patient in Phase 1 Study of BGB-283

2013年12月19日 PM10:25
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BEIJING

BeiGene (Beijing), Co., Ltd., today announced dose administration for the first patient in a Phase 1 study of BGB-283 in patients with B-RAF or K-RAS mutations. BGB-283 is an investigational, oral, selective, potent second generation inhibitor of B-RAF, 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.

“As the first second generation BRAF inhibitor to enter the clinic, BGB-283 represents one of the more exciting prospects in targeted cancer therapies,” said John Oyler, CEO of BeiGene. “BeiGene is dedicated to discovering and developing better targeted cancer therapeutics to address the unmet medical needs of cancer patients. We strive to use our deep understanding of cancer biology and translational medicine platform and our experience in drug discovery and development to bring more compounds like BGB-283 into the clinic.”

“We are very excited to have commenced dosing on the first-in-human trial of BGB-283, which has been specifically developed for the treatment of patients with BRAF and RAS driven cancers,” said Dr. Jayesh Desai, lead investigator at the Royal Melbourne Hospital and Chair of the Cancer Trials Australia Phase I Group. “All patients enrolled onto this trial will be pre-selected based on having the appropriate genomic background. This approach will hopefully accelerate our ability to understand the safety, tolerability and efficacy of BGB-283.”

BGB-283 is part of BeiGene’s two-asset strategic collaboration with Merck. Established earlier this year, the goal of the partnership is to leverage Merck’s global oncology development and commercialization expertise.

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 B-RAF or K-RAS 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 B-RAF 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 (H-RAS, K-RAS, and N-RAS) comprise up to 30% of all human cancers. B-RAF 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 focusing on discovering, developing and commercializing targeted and immune-oncology therapeutics. 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.

CONTACT

BeiGene (Beijing), Co., Ltd.
Media/Investors:
Jesse
Baumgartner, 212-362-1200
pr@beigene.com

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