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BeiGene Presents Clinical Data for RAF Dimer Inhibitor BGB-283 at the 2016 American Association for Cancer Research Annual Meeting

WALTHAM, Mass., April 17, 2016 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE) ("BeiGene"), a clinical-stage biopharmaceutical company focused on developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced the presentation of initial clinical data from an ongoing Phase I clinical trial of BGB-283 in patients with BRAF or KRAS/NRAS-mutated cancers in the Clinical Trials Plenary Session at the 2016 American Association for Cancer Research (AACR) Annual Meeting in New Orleans, LA. BGB-283 is a novel inhibitor of RAF, in both its monomeric and dimeric forms, and has demonstrated activity in both BRAF and KRAS-mutated tumors in preclinical studies. These preliminary clinical data show that treatment with single-agent BGB-283 is well tolerated with a favorable safety profile, and can result in durable responses in a range of cancers with mutations in BRAF and KRAS.

"We believe BGB-283 works differently than the currently approved BRAF V600E inhibitors, inhibiting the activity of all RAF family proteins as well as the BRAF V600E mutant protein," said Jayesh Desai
, MD, FRACP, a medical oncologist at The Royal Melbourne Hospital and Peter MacCallum Cancer Centre in Melbourne, Australia, coordinating principal investigator of the study. "The responses observed in this preliminary analysis in some patients with RAS-mutated tumors, in addition to those with the BRAF V600E mutation, appear to validate the hypothesis that inhibiting the dimeric form of RAF may demonstrate activity in both RAF and potentially some RAS mutated tumors."

"BGB-283 is a novel RAF dimer inhibitor that could potentially address an unmet need in cancer patients with RAS mutations. The initial dose-escalation clinical data on BGB-283 in a range of different solid tumors are encouraging so far. We look forward to further validation from the ongoing dose-expansion phase of this study," commented Eric Hedrick
, MD, Interim Chief Medical Officer for BeiGene.

The multi-center, open-label, dose-escalation Phase I trial in patients with solid tumors with BRAF, KRAS, and NRAS mutations, conducted at five centers in Australia and New Zealand, was designed to assess the safety, tolerability, pharmacokinetic properties and antitumor activity of BGB-283 as monotherapy. Thirty-one advanced solid tumor patients, including 12 patients with colorectal cancer (CRC), seven with lung cancer, four with melanoma, three with thyroid cancer, two with cholangiocarcinoma, two with endometrial cancer...


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