BEIJING, June 19, 2015 (GLOBE NEWSWIRE) -- BeiGene Ltd., an innovative oncology company focused on developing targeted and immune-oncology therapeutics, today announced that the United States Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for the clinical development of BGB-3111, a proprietary Bruton tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies. BGB-3111 is an investigational, oral, highly selective and potent inhibitor of BTK, a critical component of B-cell receptor (BCR) signaling that plays an important role in B-cell malignancies.
John V. Oyler, CEO of BeiGene commented "We are delighted to receive our first approval from the FDA to start clinical studies with BGB-3111 in the United States. BTK is a well validated target in B-cell malignancies and data from our pre-clinical studies indicates that BGB-3111 may demonstrate a superior efficacy and safety profile compared to the market leading BTK inhibitor. We look forward to expanding our clinical studies of BGB-3111 in B-cell malignancies into the United States over the next few months."
BGB-3111 has completed dose-escalation in Australia, and has now moved into proof of concept trials.
About the Study
The Phase I multicenter, open-label, dose escalation and expansion clinical study of BGB-3111 is designed to assess the safety, tolerability and pharmacokinetic properties and antitumor activities of BGB-3111 as a single agent. Key objectives in the study include determining maximum tolerated dose, if any, recommended phase II dose, pharmacokinetics, and preliminary anti-tumor activity of BGB-3111 in a variety of human tumors.
About BTK Proteins and Inhibitors
Bruton tyrosine kinase (BTK), a member of the TEC family of kinases, is a signaling molecule positioned within the B-cell receptor signaling cascade. BTK is predominantly expressed in B lymphocytes at various stages of development. Activation of BTK in B cells initiates a series of signaling events that leads to subsequent NF-κB activation and the expression of genes involved in proliferation and survival. Several BTK inhibitors have demonstrated sustained antitumor responses as a single agent in patients with B-cell malignancies.
About BeiGene Ltd.
BeiGene is an innovative oncology R&D company focused on immune-oncology therapeutics. With a team of 170+ scientists and staff, working from their Beijing based R&D facility; BeiGene's pipeline is comprised of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions that will have both a meaningful and lasting impact on cancer patients. For more information, please visit our website at www.beigene.com.