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news.China-based oncology firm BeiGene has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for the clinical development of BGB-3111, a proprietary Bruton tyrosine kinase (BTK) inhibitor, to treat B-cell malignancies.
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BGB-3111 is the company’s investigational, oral, highly selective and potent inhibitor of BTK, a critical component of B-cell receptor (BCR) signaling that plays a major role in B-cell malignancies.
BeiGene CEO John Oyler said: "We are delighted to receive our first approval from the FDA to start clinical studies with BGB-3111 in the US.
"TK 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."
The company said that BGB-3111 has completed dose-escalation in Australia and has now moved into proof of concept trials.
According to the company, BGB-3111 will be its first drug candidate to enter clinical trials in the US.
The multicenter, open-label, dose escalation and expansion Phase I clinical trial of BGB-3111 is designed to evaluate the safety, tolerability and pharmacokinetic properties and antitumor activities of BGB-3111 as a single agent.
The trial’s key objectives 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.