WALTHAM, Mass., Oct. 04, 2016 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE ), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncological drugs for the treatment of cancer, today announced that updated data from its Phase I study of Bruton’s tyrosine kinase (BTK) inhibitor BGB-3111 in patients with Waldenström’s Macroglobulinemia (WM) will be presented at the 9th International Workshop on Waldenström’s Macroglobulinemia and Symposium on Advances in Multiple Myeloma (IWWM-9). IWWM-9 will take place October 5–8 in Amsterdam, The Netherlands. Following its oral presentation, BeiGene will host an investor conference call and webcast to discuss the presented data.
BeiGene also announced today that updated data from its Phase I study of its PD-1 antibody BGB-A317 will be presented in a poster at the 2016 Society for Immunotherapy of Cancer (SITC) Annual Meeting, which will be held from November 11–13 in National Harbor, Maryland.
IWWM-9 Oral Presentation
Title: The BTK Inhibitor, BGB-3111, is Tolerable and Highly Active in Patients with Waldenström’s Macroglobulinemia: Interim Data from an Ongoing Phase 1 First-in-Human Trial
Authors: Constantine S Tam, Judith Trotman, Stephen Opat, Paula Marlton, Gavin Cull, David Simpson, Matthew Ku, David Ritchie, Emma Verner, Sumita Ratnasingam, Mary Ann Anderson, Peter Wood, Mark Kirschbaum, Lai Wang, Ling Xue, Eric Hedrick, John F Seymour, Andrew W Roberts
Session: Session 9 – BTK Directed Therapy in WM Date: Friday, October 7, 2016 Time: 3:45 PM CEST Location: Renaissance Hotel, Amsterdam, the Netherlands
Post-Presentation Investor Conference Call
Date: Friday, October 7, 2016 Time: 5:00 PM CEST (11:00 AM EDT, 11:00 PM China Standard Time) Dial-In Number: 1-845-675-0437 or 1-866-519-4004 (US), 400-620-8038 or 800-819-0121 (China), +852 30186771 or 800906601 (Hong Kong), +65 67135090 (International)
Conference ID Number: 84900844
A live webcast and replay of the event will be available on BeiGene’s investor website, http://ir.beigene.com/ . The dial-in replay will be available approximately two hours after the conference and will be available for two days following the event. It can be accessed by dialing 1-646-254-3697 (US), 400-632-2162 (China), +852 30512780 (Hong Kong), or +61 2 8199 0299 (International).
2016 SITC Annual Meeting Poster Presentation
Title: Updated safety, efficacy, and pharmacokinetics (PK) results from the phase I study of BGB-A317, an anti-programmed death-1 (PD-1) mAb in patients with advanced solid tumors
Authors: Jayesh Desai, Ben Markman, Shahneen Sandhu, Hui K. Gan, Michael Friedlander, Ben Tran, Tarek Meniawy, Joanne Lundy, Duncan Colyer, Malaka Ameratunga, Christie Norris, Jason Yang, Kang Li, Lai Wang, Lusong Luo, Zhen Qin, Song Mu, Xuemei Tan, James Song, Michael Millward
Poster Number: 159 Poster Presentation Session Date/Time: Friday, November 11, 2016, 12:15-1:30 PM EST, 6:15-7:30 PM EST Location: Gaylord National Hotel & Convention Center, National Harbor, Maryland
About BGB-3111
BGB-3111 is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that has demonstrated higher selectivity against BTK and higher exposure than ibrutinib, the only BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency. In addition, available clinical data with BGB-3111 demonstrated sustained 24-hour BTK occupancy in the blood as well as the lymph node.
About BGB-A317
BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1, and we believe it is differentiated from the currently approved PD-1 antibodies with the ability to bind Fc gamma receptor I specifically engineered out. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.
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 250 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 BeiGene’s advancement of, and anticipated development and regulatory milestones and plans related to, BeiGene’s drug candidates and clinical trials, including providing data readouts and updates for its clinical candidates. 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, 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 ir@beigene.com media@beigene.com
