Date: 2017-03-08
Type of information: Clinical research agreement
Compound: BGB324 and pembrolizumab
Company: BergenBio (Norway) Merck&Co (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism:
- monoclonal antibody/immune checkpoint inhibitor/AXL inhibitor/ receptor tyrosine kinase inhibitor. BGB324 is a first-in-class, highly selective small molecule inhibitor of the Axl receptor tyrosine kinase that blocks the epithelial-mesenchymal transition, which is a key driver of metastasis and drug-resistance.. Preclinical in vivo studies have shown that BGB324 has both single agent activity in leukemia and solid tumors and is very effective in preventing and reversing acquired resistance to existing therapies including cytotoxics, protein kinase inhibitors and other targeted therapies.
- Keytruda® (pembrolizumab - MK-3475) is an highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system.
Disease: dvanced non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC).
Details:
- • On March 8, 2017, BerGenBio announcde it has entered into a collaborative agreement with Merck & Co, through a subsidiary, focused on the clinical evaluation of BGB324 with KEYTRUDA® (pembrolizumab) in patients with advanced non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).
- Under the terms of the collaboration, BerGenBio will conduct two international Phase II studies to evaluate the potential clinical synergy of combining BGB324 with MSD’s anti-PD-1 therapy, Keytruda®. Details of the studies are as follows:
- -BGBC007 – A Phase II multi-centre study of BGB324 in combination with Keytruda® in patients with previously treated, locally advanced or unresectable TNBC.
- -BGBC008 – A Phase II multi-centre study of BGB324 in combination with Keytruda® in patients with previously treated unresectable adenocarcinoma of the lung.
- Biomarker studies will be conducted in parallel to the above studies with the goal of developing companion diagnostics to identify patients who would be most suitable for treatment with the BGB324/Keytruda® combination.
- The clinical trials will be sponsored by BerGenBio while MSD will provide the trial with Keytruda®. The rights to the study results will be shared. No further details are disclosed.
Financial terms:
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