BeiGene Announces Initiation of a Combination Trial of the BTK Inhibitor BGB-3111 With the PD-1 Antibody BGB-A317
BeiGene, Ltd. recently 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,” said 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 3 weeks. It is anticipated that about 25 patients will be enrolled into the study. The trials will be conducted across four centers in Australia.
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 US FDA 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.
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.
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 US, 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. For more information, visit www.beigene.com.
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