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BeiGene Announces Initiation of a Combination Trial of the BTK Inhibitor BGB-3111 with the PD-1 Antibody BGB-A317

WALTHAM, Mass., June 29, 2016 (GLOBE NEWSWIRE) -- BeiGene, Ltd., a clinical-stage biopharmaceutical company focused on developing molecularly targeted and immuno-oncology drugs for the treatment of cancer, today announced the dosing of the first patient in a Phase I clinical trial of BGB-3111, a Bruton’s tyrosine kinase (BTK) inhibitor, in combination with BGB-A317, a PD-1 antibody, for the treatment of various B-cell malignancies. This combination study of two internal drug candidates wholly-owned by BeiGene follows an ongoing study of another internal combination of BGB-A317 with PARP inhibitor BGB-290.

“We have presented initial clinical data on both of these candidates as single agents,” commented Eric Hedrick, MD, Interim Chief Medical Officer at BeiGene. “We believe the combination of BGB-3111 and BGB-A317 in clinical trials has been well-supported by compelling preclinical data. Additionally, we believe ownership of both components in the combination regimen puts us in an advantageous position to develop the regimen to its full potential.”

The Phase I multi-center, dose escalation and expansion clinical trial of the BGB-3111 and BGB-A317 combination is designed to assess the safety, tolerability, pharmacokinetics, and anti-tumor activities of this combination in patients with B-cell lymphoid malignancies. BGB-3111 will be dosed orally and BGB-A317 will be administered intravenously every three weeks. It is anticipated that about 25 patients will be enrolled into the study. The trials will be conducted across four centers in Australia.

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 both the blood as well as the lymph node.

About BGB-A317

BGB-A317 is an investigational humanized monoclonal antibody that belongs to a new 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 differs from the currently approved PD-1 antibodies with the ability to bind Fc gamma receptor I specifically engineered out.

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 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 a 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 preliminary clinical data of both BGB-3111 and BGB-A317, the potential implications of these data for the future development of BGB-3111 and BGB-A317, including the combination of these drug candidates, and anticipated clinical development and regulatory milestones and plans related to the combination of BGB-3111 and BGB-A317. 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 our 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

Source: BeiGene, LTD.