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