BeiGene Announces Presentation of Phase IB Data on BGB-283 at the 2017 American Association for Cancer Research Annual Meeting

19:00 EST 1 Mar 2017 | Globe Newswire

CAMBRIDGE, Mass., March 02, 2017 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that it will present data from the Phase IB dose expansion study of RAF dimer inhibitor BGB-283 in patients with B-RAF or K-RAS/N-RAS mutated solid tumors in an oral presentation during a Clinical Trials Plenary Session at the 2017 American Association for Cancer Research (AACR) Annual Meeting. In addition, the company expects a decision in the first quarter of 2017 from its partner Merck KGaA on its continuation option to develop and commercialize BGB-283 outside China after Merck’s review of Phase I data.

At AACR, BeiGene will also present three posters related to its pipeline agents, BGB-A317 (PD-1 antibody), BGB-3111 (BTK inhibitor), and BGB-A425 (Tim-3 antibody). The AACR Annual Meeting will take place April 1-5 in Washington, DC. Details for the oral presentation and posters are provided below. Further details can be found on the AACR website.

Oral Presentation, Abstract # CT002

Title: A Phase IB study of RAF dimer inhibitor BGB-283 in patients with B-RAF or K-RAS/N-RAS mutated solid tumors

Authors: Jayesh Desai, Hui Gan, Catherine Barrow, Michael B. Jameson, Benjamin Solomon, Victoria Atkinson, Andrew Haydon, Michael Millward, Stephen Begbie, Michael Brown, Benjamin Markman, William Patterson, Andrew Hill,  Lisa Horvath, Adnan Nagrial, Gary Richardson, Christopher Jackson, Michael Friedlander, David  Gibbs, Phillip Parente, Jason Yang, Lai Wang, Yunxin Chen, Lusong Luo

Presenter: Dr. Jayesh Desai

Session: Precision Medicine Clinical Trials

Date: Sunday, April 2, 2017

Time: 12:45 PM - 3:00 PM ET

Location: Ballroom C, Level 3, Washington Convention Center

Poster Presentations:

Abstract #2010: Hu N. et al., BTK inhibitor BGB-3111 demonstrates anti-tumor activity in solid tumor models. Mon., Apr. 3, 8:00 AM -12:00 PM

Abstract #2628: Zhang T. et al., BGB-A425: a humanized anti-human Tim-3 antibody that exhibits strong immune cell activation. Mon., Apr. 3, 1:00 PM – 5:00 PM

Abstract #5626: Luo L. et al., Investigation of T cell activation by anti-human PD-1 antibodies Nivolumab, Pembrolizumab and BGB-A317 using tumor-infiltrating lymphocytes (TILs) from colorectal cancer and colorectal liver metastasis patients. Wed., Apr. 5, 8:00 AM – 12:00 PM

About BGB-283 and Merck KGaA Agreements

Discovered by BeiGene scientists, BGB-283 is a novel RAF inhibitor with unique RAF dimer and EGFR inhibition activities. BGB-283 has shown antitumor activities in preclinical models and in cancer patients not only in tumors with BRAF V600E mutation but also those with non-V600E BRAF mutations and KRAS/NRAS mutations.

BGB-283 was partnered with Merck KGaA in 2013 prior to the initiation of its clinical development. Pursuant to the license agreements for territories in and outside China respectively, BeiGene has exclusive development and commercial rights to BGB-283 in China, and Merck KGaA has an exclusive license to develop and manufacture BGB-283, and, subject to the exercise of a continuation option based on review of Phase I data, to commercialize and manufacture BGB-283 in markets outside of China. BeiGene retained the responsibility to perform pre-specified Phase 1 clinical trials and if Merck KGaA exercises its continuation option, it will pay BeiGene a continuation fee based on the costs of conducting the relevant trials, subject to a certain cap. If Merck KGaA does not exercise its continuation option, the ex-China agreement will terminate in its entirety except for certain provisions that will survive the termination.

About BeiGene

BeiGene is a global, clinical-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 300 scientists, clinicians and staff in mainland China, the United States, Australia and Taiwan, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the timing of Merck KGaA’s decision to exercise its continuation option to develop and commercialize BGB-283 outside China after Merck’s review of Phase I data. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; BeiGene's ability to achieve market acceptance in the medical community necessary for commercial success; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct preclinical studies and clinical trials; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

Investor/Media Contact

Lucy Li, Ph.D.
+1 781-801-1800

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